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U.S. Department of Health and Human Services

Regulatory Information

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Stakeholders Comments Organized by FDAMA Objectives

FDAMA Objective: A

 

Maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications and any other similar forms of request) made under this Act.

11023 Streamline the process for approval of food and color additive petitions
11063 Develop a simplified Generally Recognized as Safe (GRAS) notification procedure, in addition to the current procedure
11067 Significantly improve the food additive approval process to increase efficiency, predictability, and accountability
11068 Enhance communication in the food additive approval process with emphasis on presubmission consultations
11103 Place notifications for health claims in a public docket so that interested parties can review the submission and provide comments to the Agency on the scientific validity of the claim
12021 Improve information provided to consumers and improve clinical trial information provided to regulatory and health care professionals
12057 Collaborate and interact more with the regulated industries to avoid issuing guidance documents that do not adequately take into account useful perspectives that can be provided by industry to the Food and Drug Administration (FDA)
12058 Model Agency and industry interaction after that used for pregnancy labeling; by contrast, the guidance on gender was unproductive because it was issued as a final rule without industry input
12068 Make sure true experts of the disease under review are represented on the Advisory Panel, given the deference that FDA gives these panels
12069 Utilize expertise from the World Federation of Neurology and the Committee of Motor Neuron Disease in the Amyotrophic Lateral Sclerosis (ALS) review process
12070 Use ad hoc review from experts in diseases such as ALS
12071 Explore further options to effectively incorporate patient testimonies into the process
12072 Educate patient advocacy groups, disease-specific organizations, disease experts, and new biotechnology companies about FDA's function, process, and scope
12073 Solicit information regarding potentially effective drugs in certain diseases from the disease-specific groups
12084 Arrange public input in Advisory Panels so that data remains scientific rather than emotional
12089 Collaborate with the Pharmaceutical Research and Manufacturers of America (PhRMA) in the development of guidance documents and pilot programs instead of soliciting PhRMA's input after guidance issued or pilot programs are initiated
12103 Have Congress investigate the publishing processes for information about results of clinical trials and provide the FDA with adequate resources to monitor clinical trial quality
12113 Time public comment periods in Advisory Committee meetings after the sponsor and the Agency have both had a chance to present data and discuss it
12151 Develop methods for candidly presenting approval issues to the public
12171 Ensure that Advisory Committee members have the adequate skill level necessary
12172 Include at least one clinical pharmacologist and one biopharmaceutical scientist on every Advisory Committee
12175 Dedicate resources and staff to ensure that public reporting of all clinical trials is done as required under the Food and Drug Administration Modernization Act (FDAMA)
13005 Convene a working group from the regulated industries to review present Agency use of Advisory Panels and make recommendations as to how the process might be improved to maximize their utility to the FDA
13007 Reach out to stakeholders for discussion of outdated or vague regulations or guidance documents
13012 Make procedures more transparent, particularly in terms of Good Review Practices (GRPs)
13013 Provide to industry and stakeholders copies of GRPs, as well as Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) Reviewer Handbooks, plus Manual of Policies and Procedures (MaPPS) for New Drug Application (NDA) and Investigational New Drug (IND) reviews, even though these documents may still be in draft form
13014 Allow more time for companies to respond to FDA proposed labeling changes near the end of the review period
   
13015 FDA should put information about all new products on the Internet at the time of approval
13038 Take further steps in publishing proposed regulations in a timely fashion, providing adequate comment periods, providing early dissemination of draft guidance documents, and holding more frequent Agency workshops on regulatory changes
13039 Strictly adhere to the FDA Good Guidance Practices document
13040 Broaden the Good Guidance Practices document's scope of application
13041 Work with groups like the Coalition for Regulatory Reform (CFRR) and others in developing even initial drafts of Agency guidance documents
13045 Issue guidance documents specific to blood and plasma for CBE30 Supplements (changes to an approved application)
13046 Issue guidance documents specific to blood and plasma for annual reports
13047 Issue guidance specific to blood and plasma for comparability protocols
13048 Engage industry in a dialogue about the pilot program for approval of certain blood and plasma products through a monograph system
13064 Expand the use of guidance documents and notifications to facilitate licensed blood center use of new technologies where the technology has a proven track record for many years, or where the benefits clearly outweigh the risks
13077 Develop clear guidelines for the use of the comparability protocol process
13079 Think more innovatively about improving the ranking and grading of specific blood and blood products as the foundation of the blood licensure review process
13083 Define what information is necessary to evaluate the licensure submission reviews
13084 Create a tier for submissions and reviews based on hazard and impact
13089 Guidance should describe the obligations of both the sponsor and the FDA in setting up meetings
13090 Have a classification for meetings (e.g., A, B, C) with defined timelines (e.g., 30, 60, 75 days) for holding the meeting after the request
13091 Prepare common minutes from meetings to be provided by FDA within 30 days with comments from the sponsor within 10 days
13092 Have monthly updates or a progress report of a submission, specifically a fast track submission
13094 Define the concept of a comparability protocol
13102 Include discussion of the selection process for surrogate end points in guidance documents
13105 Provide recommendations in the surrogate end point guidance document with regard to quality-of life-scales as perhaps the primary clinical end point
13106 Provide recommendations and guidance in the surrogate end point guidance document with regard to dissemination of information on surrogate end points
13110 Notify the sponsor in advance of the withdrawal of a fast track designation and give them an opportunity to meet informally with the FDA prior to the final notification
13113 Develop a general schedule with the sponsor, with major action dates and milestones, so that both parties are very clear on what is expected when an IND receives a fast track designation
13114 Work with sponsors to obtain early approval and agreement on the protocol for a fast track IND
13115 Create an information or tracking system for fast track New Drug Applications/Biologic License Applications (NDA/BLAs) that allows companies to track the status of their NDA/BLA through the process
13137 Adopt CBER's model of providing the sponsor a copy of the draft submission document prior to submitting it to the Advisory Panel
13138 Put more self-reviewing or self-policing mechanisms in place (e.g., defining and developing more uniform timetables Agency-wide that would be adhered to)
13153 Configure Advisory Committees to have consumer representatives as an essential component in the FDA regulatory process
13154 Continue to use consumer advisors
13164 Communicate via a policy memorandum any decisions that come out of back and forth communication with industry, building upon guidance documents that exist
13165 Provide as much feedback to industry as possible in the earliest time frame because many of the questions that are generated will result in long-term experiments or clinical trials
14001 Formally communicate the basis for significant new submission/review requirements to industry before demanding compliance
14045 Make the Center for Veterinary Medicine's (CVM's) stakeholder involvement in decision-making a transparent process but formalized through the Federal Register; a good model to follow is the United States Department of Agriculture's (USDA's) building the Hazard Analysis Critical Control Points (HACCP) rule
14052 Do a better job of developing and explaining to stakeholders the principles that guided policy decisions (i.e., the evaluation of needs of the animal versus needs of the public)
14076 Work closely with sponsors to ensure submissions are in the proper format, possibly through the use of a sample submission guide
14078 Target key industry persons who can provide alerts on new products that are in the pipeline to the Federal Register and have already been approved by the FDA
14095 Continue emphasis on providing education, information, and compliance assistance to regulated industry
14096 Use teleconferencing and the Internet to communicate with the industry
14097 Partner with industry organizations to produce brief, concise, and consumable information that will be useful for smaller establishments
14104 Use industry organizations to assist in developing literature that uses industry terminology, writing in a less regulatory way, and stressing the importance of compliance
14113 Make science-based decision-making understandable and clear
14116 Include a broad variety of scientists, such as chemists, physiologists, immunologists, biostatisticians, etc., in the CVM Advisory Committee, not just clinicians
15018 Publish a flow chart of all the internal processes that FDA has for all submissions, e.g., 510 (k)s, Device Premarket Approval Applications (PMAs), Investigational Device Exemptions (IDEs), etc. to promote better understanding
15019 Make available more templates, prototypes, and examples to give industry greater understanding
15033 Put prototype abbreviated submissions on the web and give clear instructions and encouragement on how to use them
15039 Revisit the structure and number of FDA Advisory Committees in order to increase the number of participants, broaden the committee's mission, and increase the total number of committees
15047 Clarify FDA expectations better to industry to help minimize differences of scientific opinion, and so the industry knows exactly what is needed from them to move forward efficiently
15058 Make consumer representatives on Advisory Panels an integral part of the process from the beginning
15062 Prepare the consumer representatives on Advisory Panels for their role and be invested in helping them overcome the technical and cultural barriers.

FDAMA Objective: B

Maximizing the availability and clarity of information for consumers and patients concerning new products.

11030 Increase the amount and effectiveness of food safety educational efforts for food preparers and food service at the retail level and the home
11038 Develop educational programs for consumers, with a special emphasis on children, young adults, and other vulnerable populations
11076 Increase the number of educational programs for consumers and food handlers
11101 Target programs that ensure that consumers know what they are buying and act decisively in cases of mislabeled products
11105 Develop effective communication strategies about dietary supplements for use by health professionals by working with the American Dietetics Association (ADA), the American Heart Association (AHA), and the National Institutes of Health's (NIH's) Office of Dietary Supplements, among others
11106 Research consumer perception of labeling information of foods and dietary supplements, sharing the cost among the FDA, the food and dietary supplement industry, and other organizations
12001 Make FDA an information source
12004 Reevaluate CDER's policy on direct-to-consumer advertising
12005 Submit a formal CDER proposal to the administration for delivery to Congress to permit distribution of peer-reviewed articles on unapproved uses directly to prescribers
12006 Stay the course with FDA's policy on controlling marketing through pharmacy benefits management companies (PBMs) directly to physicians and pharmacists
12009 Use a consumer panel to assess reactions to drug advertisements
12010 Do not depend on scientists to review direct-to-consumer advertisements
12011 Define appropriate direct-to-consumer messages; they may be different for individual drugs
12012 Solicit input and directions from health care professionals and ethnic communities in the review processes for direct-to-consumer advertisements
12021 Improve information provided to consumers as well as clinical trial information provided to regulatory and health care professionals
12022 Ensure the validity of and integrity of drug information provided on the Internet
12023 Improve information dissemination by using articles in professional journals, Internet messages, consumer articles, and news media
12024 Counter some of the direct-to-consumer advertisements by using radio and television ads, consumer magazines, and health or trade magazines
12025 Place drug information in physicians' offices, patients' rooms in hospitals, and in emergency rooms for consumers' access
12026 Improve access to package inserts for both the public and regulators
12027 Use an FDA Internet board to provide drug information to various entities
12045 Continue FDA's policy on direct-to-consumer ads that serve the public health interest, particularly with the increased move to self-care management
12049 Give health care providers needed access to the latest scientific information on medicines
12050 Distinguish dissemination of information from promotion
12051 Consider that information on off-label use, such as peer-reviewed scientific journal articles, is appropriate to provide to health-care providers by research pharmaceutical manufacturers
12052 Assure that any regulatory limitations on the flow of off-label use information is: a) minimally intrusive, and b) consistent with constitutionally guaranteed speech rights and FDAMA
12053 Consider electronic package inserts as a positive means of spreading information to consumers and health care professionals
12055 Collaborate with the pharmaceutical industry to educate Congress, the press, and the public about the vast amount of safety activities already in place
12082 Begin to organize information on how FDA counsels people, collects data on them, and makes sure that consumers know how to use products
12106 Rethink FDA's role regarding direct-to-consumer advertising
12107 Find ways to strengthen standards for direct-to-consumer advertising
12108 Request more resources for more aggressive policing of ad content
12109 Include a greater emphasis on public education as part of monitoring direct-to-consumer advertising
12110 Make the public aware when companies have been asked to revise or pull ads, and explain why
12112 Ensure that consumers have access to an independent source of information on drugs that can match the accessibility of savvy direct-to-consumer advertising
12114 Commission research to determine which formats of supplemental written information are most useful in terms of improving consumers' medicine adherence and health outcomes as determined by a health care professional
12115 Commission research to determine which formats of supplemental written information are most useful in terms of improving information exchange between the patient health care professionals
12116 Support the development of a collaborative, national consumer medicine safety and education program to educate consumers and health providers about changes and improvements in prescription medicine information
12117 Support the development of a collaborative, national consumer medicine safety and education program to promote question asking and information sharing as valuable tools to improve communication, knowledge, and usefulness
12118 Support the development of a collaborative, national consumer medicine safety and education program to better equip consumer and caregivers to recognize and report medication-related errors
12119 Develop a memorandum of understanding to organize and support a collaborative, national consumer medicine safety and education program modeled after the partnership for food safety education
12120 Disseminate initial campaign messages by October 1999 to coincide with the 134th national "Talk about Prescriptions" month, which could be reformulated as "National Medicine Safety and Education Month"
12121 Participate with consumer organizations, industry groups, and other stakeholders in the "National Medicine Safety and Education Month" by contributing resources towards collaborative message design, testing, implementation, and evaluation
12122 Develop a sustained national consumer education program
12123 Provide consumer access to full information about all medicines
12124 Allow direct-to-consumer advertising that is educational about the availability of prescription drug therapies for specific medical conditions, rather than direct-to-consumer advertising of specific prescription drug products
12125 Continue to make package insert information available by way of the Internet
12126 Make package insert information available on the Internet for drug products approved before January 1998 as well as those approved after that date
12127 Provide a fax-on-demand service for access to package inserts, postmarketing surveillance data, and special alerts
12128 Provide a widely publicized hotline for telephone access to information from consumers and professionals
12129 Keep Internet information on approved drug products up to date and expanded with respect to unlabeled uses
12137 Develop specific criteria to be determined and consumer tested and evaluated for what constitutes useful accompanying patient education information in conjunction with direct-to-consumer advertisements
12138 Engage in promotion and advertising about FDA's website
12141 Make available to private sector organizations information and data obtained by FDA in consumer focus groups and research surveys to encourage them to build and develop their own research base
12150 Make basic information readily available
12151 Develop methods for candidly presenting approval issues to the public
12152 Review more stringently the content and level of information provided in direct-to-consumer advertising
12153 Revisit the Congressional mandate for a private sector solution for providing consumers and patients with information about prescription drugs mandated by Public Law (PL) 104180
12154 Begin immediately a process of review of the quality of written prescription drug information being provided to consumers and patients in preparation for the year 2000 evaluation as stated in PL 104180
12155 Provide educational resources for patients and providers
12156 Use the Centers for Education and Research (proposed for NIH) to support patient-oriented, post-approval research and to improve prescriber education
12162 Develop and support an infrastructure to communicate quality, objective drug information to the public and prescribers
12163 Support the United States Pharmacopeia Drug Information (USP-DI)
12164 Develop an Internet-based drug label database
13016 Allow companies and other groups to provide well-documented information on marketed drugs using market forces
13018 Work with the pharmaceutical industry to educate Congress, the press, and the public about the vast amount of safety activities already in place
13028 Educate the public about benefit-to-risk ratios
13037 Give industry an opportunity to present its viewpoints and its perspectives to the field staff
13069 Continue efforts to enhance information on FDA's home page, adding search capability and better links and organizations
13071 Continue efforts toward more open communication between the FDA, consumer groups, and professional societies
13072 Expand an effective communication policy to all levels of FDA and CBER by reexamining the current practices for working with the regulated community and other groups
13073 Work with the regulated community in a more open style of addressing issues by directing our approaches toward resolution as partners
13120 Allow industry some discretion to tailor disclosures to appropriately give the healthcare professional the information about what the specific limitations are, or the specific problems, or information in the article that is dealing with off-label uses
13128 Follow the intent of Section 114 of the statute in the drafting of the guidance on dissemination of economic information
13151 Allow the FDA Office of Consumer Affairs to manage solutions to patient and physician outreach and coordination of information
13162 Give industry guidance on how they could help preserve the current collaborative interactions
13163 Give industry guidance on how it can give FDA a better heads-up on questions and issues that it might find necessary to discuss
14016 Communicate and conduct outreach more efficiently by collaborating with the American Association of Swine Practitioners (AASP) and other similar organizations
14042 Release information on: kinds, amounts, and methods in places of delivery of antimicrobials used at sub-therapeutic and therapeutic levels in food animals (i.e., livestock, poultry, fish and other food animals) in the U.S.
14043 Release information on surveillance and monitoring of the use of antibiotics in animal agriculture and the emergence of antibiotic-resistant animal and human pathogens
14049 Tap into the resources of the industry and continue to build partnerships (e.g., using the National Pork Producers Council's (NPPC's) extensive network of communication and educational contacts)
14077 Post all product information on the web site
14078 Target key industry persons who can provide alerts on new products that are in the pipeline to the Federal Register and have already been approved by the FDA
14085 Use the professional and commodity groups to help educate and communicate to the end users
15001 Move maximum number of resources to the goal of education, communication, and dissemination of information
15020 Refer inquiries about new products, new drugs, etc. to appropriate parties, (e.g., professional societies, companies, etc.) in order to maximize information about new products
15021 Consider listing hyper-links on Internet sites to trade organizations, associations, etc so that parties with interests in new products can easily connect
15044 Communicate more vigorously with the public through libraries, volunteer groups, schools, and tell the public what they need to know and what to ask their physicians
15046 Employ more plain language on device labels so that the lay public understands proper device use better
15048 Fund and empower the Office of Women's Health to develop an expanded outreach program that provides understandable information on adverse events and injuries
15049 Make risk and safety data and statistics available to the public via the 800 Consumer Information Line
15069 Communicate more with professional societies and other organizations.

FDAMA Objective: C

Implementing inspection and postmarket monitoring provisions of this Act.

11001 Be a leader in food safety, (i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors)
11002 Respond to state requests for assistance in a timely manner
11004 Reassemble the HACCP core committee to determine whether a universal HACCP regulation for food processing industry is warranted
11005 Redirect resources for economic fraud and mislabeling issues
11006 Work with state programs to monitor imported foods
11007 Devote more attention to imports while letting the states deal with domestic concerns
11008 Develop a vertically integrated national food safety regulatory system
11014 Focus on HACCP implementation for shellfish
11015 Develop program evaluation criteria and training to ensure consistency and uniformity in state shellfish programs
11016 Nurture relationships in cooperative programs through HACCP implementation and state shellfish programs
11022 Educate all food handlers in the distribution chain on food safety practices
11025 Strengthen the Center for Food Safety and Applied Nutrition's (CFSAN's) leadership role in Codex activities
11032 Work to harmonize the regulation of the global food supply
11033 Increase resources for Codex activities
11034 Modernize food standards
11035 Exercise a visible and effective enforcement presence where there is egregious economic fraud, such as in the adulteration of high-value juices
11036 Apply HACCP regulations to fishing vessels that do not process their catch
11040 Play an active role in Codex to ensure that international standards and guidelines are consistent with U.S. requirements
11041 Move aggressively to negotiate effective international agreements for on-site seafood HACCP inspections
11042 Enhance oversight of economic violations
11048 Take action against deceptive label claims
11052 Safety and labeling standards should be harmonized in an upward fashion to reflect the best consumer protection and public health requirements
11053 Do not eliminate food standards
11060 Renew contract with the Food Chemicals Codex
11065 Promote harmonization
11066 Improve leadership in the Codex
11069 Reverse the decision to cancel inspection and compliance programs for cosmetics
11070 Be a leader internationally in the harmonization of regulatory requirements for cosmetics
11074 Move towards a voluntary HACCP-based system for dairy products, away from checklist inspections and prescriptive plant processing regulations
11075 Reduce consumers' risk from imported foods
11080 Expand the In Flight Food Service Association-FDA HACCP pilot project to other FDA regions
11081 Use the In Flight Food Service Association-FDA HACCP pilot project as a model for HACCP retail
11084 Improve handling of adverse event reports to involve the industry earlier when problems are identified
11085 CFSAN should continue work in risk assessment and international activities
11088 Improve the handling of adverse event reports
11089 Work closer with the industry on postmarket surveillance and tracking of adverse reaction reports when problems arise
11090 Mandate that fruit and vegetable juices be pasteurized or otherwise processed to ensure their safety
11091 Implement HACCP regulations for foods with a demonstrated high risk, (e.g., unpasteurized juice)
11093 Improve international food safety standards through cooperation in Codex
11094 Promote national uniformity and harmonization among federal and state agencies
11095 Continue the food standards program
11096 Prevent economic fraud
11101 Target programs that ensure that consumers know what they are buying and act decisively in cases of mislabeled products
11104 Continue to strengthen the efforts surrounding dietary supplements
12002 Create a new classification system for prescription pharmaceuticals
12003 Seek to ban the practice of sampling and replace it with a system that can facilitate starter doses through normal distribution mechanisms
12007 Work more effectively and proactively with prescribers and pharmacists to promote swift reporting of all adverse effects
12008 Encourage manufacturers to utilize the latest notification technology to report adverse events
12013 Create a new clear understanding of CDER's relationships to the districts and the regions regarding inspections
12014 Communicate the relationship between CDER, the districts, and regions down to the consumer level, or at least to State and local regulatory levels
12015 Devote more time to the inspection process to allow for more comprehensive rather than just product-specific inspections
12016 Focus district inspections on the health impact of the regulations, not just the "black and white" of the regulations
12018 Perform periodic quality inspections and laboratory analyses for identity, potency, and purity to ensure that quality of drugs in foreign countries equals ours.
12019 Have equivalent standards in foreign countries and effective regulatory programs as well
12020 Expend more time in foreign oversight and use the states to cover domestic regulatory oversight at their level
12028 Direct emphasis toward decreasing the number of adverse events, then secondly concentrate on the passive reporting system
12029 Give consideration to mandatory reporting in hospitals similar to the medical device reporting requirements
12031 Consider regular continuous reminders to health care professionals and regulators about a critical outcome associated with FDA; usually only one message is received from FDA
12032 Improve the MedWatch report with better exchange of information with the states and the industry (e.g. reports to states on a continuous basis and reports to FDA on a continuous basis)
12039 Interact more with states to include joint work planning and areas of shared responsibilities
12040 Incorporate into the Centers models of interaction with the states that exist in the FDA regional offices
12041 Focus attention on imports
12042 Review and update the personal use policy to address concerns and complaints related to the quality of these products and the probability of diversion into normal commerce
12047 Take a more comprehensive approach in the management and coordination of Good Manufacturing Practices (GMP) inspections
12048 Involve different parts of the FDA, along with regulated industry, in a collaborative effort aimed at assuring an efficient and effective inspection program
12056 Work with the pharmaceutical industry, patients, doctors, pharmacists, hospitals, Congress and anyone else to monitor the safety of medicines after marketing
12077 Create a system or category for drugs that need monitoring, so that when the pharmacist and physician are ordering them, the system prevents a patient from getting a second refill until necessary tests are done
12078 Require reporting so that we could get more denominator data from the adverse drug reactions (ADRs)
12079 Apply resources to collect pharmaceutical statistics when a specific issue arises
12083 Create a more tightly controlled system and better record keeping on some of these products (e.g. anabolic steroids) so we can know where they are being used
12088 Allow PhRMA to help the Agency design a program of first-party audits with benefits for both participating firms and the Agency
12090 Find a way in which the Agency is comfortable sitting down to discuss first- and third-party audits
12091 Encourage the states to try and follow models/statutes that mirror the federal statute
12092 Improve state contract program and incorporate other states into those arenas that don't have formalized contracts or partnerships
12094 Sort out the blame when a failure of a drug product occurs
12095 Develop systems to target which drugs should be monitored and for which drugs information should be collected
12096 Stimulate large health insurers to get ADR information back to companies and then out of the companies and back to the FDA
12097 Measure success not only by the number of drugs and devices approved, but also by a reduction in number of deaths, adverse reactions, and recalls reported
12101 Create an Office of Drug Safety
12108 Request more resources for more aggressive policing of ad content
12110 Make the public aware when companies have been asked to revise or pull ads, and explain why
12129 Keep web information on approved drug products up to date and expanded with respect to unlabeled uses
12130 Consider ways to allow anonymous reporting to the MedWatch program
12131 Schedule MedWatch communications about specific problems several times per year in addition to special alert notices for urgent circumstances
12132 Formally adopt a standardized taxonomy of reportable events if such is developed by the National Coordinating Council on Medication Error Reporting and Prevention
12133 Remain open to the possibility of redefining terms such has "Medication Errors," "Adverse Drug Reactions" and "Adverse Drug Events" if these are standardized by other interested parties
12135 Continue to allow access to MedWatch database by others, with appropriate shielding of confidential aspects
12136 Prioritize analysis of the MedWatch database
12139 Have regularly scheduled appearances of the MedWatch alert so people will begin to anticipate them and appreciate the information
12140 Have periodic summaries of the safety alerts that are issued as the events occur
12145 Create an Office of Drug Safety to fulfill surveillance and adverse event reporting in CDER
12146 Compel drug sponsors to conduct post-approval trials that are agreed upon at the time of approval, especially for priority drugs
12147 Develop a stronger system for compelling sponsors to conduct controlled studies, to confirm clinical efficacy, and to expand the limited knowledge base that formed the basis for approval
12148 Ensure that reports on individual, post-approval studies provide information that has sufficient detail to be meaningful
12157 Increase the drug safety staff
12159 Make postmarketing safety decisions independent from the medical review process
13008 Use PDUFA II extra funding to streamline adverse reporting and data analysis
13009 Work with stakeholders on streamlining adverse reporting and data analysis as issues are identified
13019 Work with the pharmaceutical industry, patients, doctors, pharmacists, hospitals, Congress and others to improve the system for monitoring the safety of medicines after they are on the market
13023 Collaborate with other regulatory agencies worldwide
13049 Rewrite the GMPs in a comprehensive manner to incorporate the 200, 600, and 800 series regulations into one set of unified regulations for blood and plasma products
13050 Perform analyses and trend reporting on error and accident reports and make this available to the industry
13051 Develop a more rational recall and withdrawal policy to save Agency resources
13058 Examine historical experience with the current error and accident reporting system before extending it to other areas
13065 Analyze for and identify the lowest common denominator in areas where CBER, the Center for Devices and Radiological Health (CDRH) or CDER regulate similar technologies for similar uses, and use this to develop a more unified approach to regulatory policy and enforcement
13067 Analyze the risks and benefits of the European community's policy toward blood processing solutions as device accessories versus drugs
13068 Continue international harmonization efforts until a single global dossier is recognized for all blood and plasma products, related drugs, and devices
13074 Continue interaction with work groups such as the CFRR to seek resolution of outstanding issues such as those relating to adverse reactions, errors and accidents, and product retrievals
13078 Think more innovatively about providing clear guidance about the requirements for the new annual report process
13081 Think more innovatively about expanding the regulations to directly reference blood and blood products instead of trying to fit them into a system with which they do not harmonize
13086 Expand public input into the error and accident reporting program beyond the regulated community that would be submitted to an independent agency and shared among the regulated community
13088 Move toward global regulation of blood and blood technology products
13125 Permit Internet reporting for some of the reporting requirements under the statute
13146 Continue to consider supply while ensuring that the manufacturers are in compliance with GMPs
13147 Stagger inspections
13149 Phase in inspections and allow lot release while improvements are being made
13167 Create a system to handle shortage and allocation strategy
14005 Direct more effort toward preventing distribution of illegally marketed or compounded products, and those practices that are outside the provisions of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) regulations
14007 Find a way to avoid having two separate people (i.e., field investigator and center compliance officer) perform a science and Current Good Manufacturing Practice (CGMP) compliance review of voluminous data (i.e., less amount of time and greater consistency)
14009 Avoid third-party efforts at this time
14010 Examine how surveillance and compliance resources are used on companies marketing properly versus companies that are marketing illegally or compounding improperly (e.g., mail-order pharmacies)
14011 Increase enforcement in the area of illegal distribution of prescription drugs to end users without authorization from a veterinarian in a valid veterinarian/client/patient requirement
14013 Have compliance and surveillance staffs consider it a priority to provide information on AMDUCA to the American Veterinary Medical Association (AVMA) journal
14015 Educate third parties and help them understand Veterinarian-Client-Patient Relationship (VCPR) if they are used for surveillance or compliance work
14017 Seek voluntary restrictions on post-approval monitoring programs for antimicrobial resistance rather than regulatory approaches
14028 Simplify the post-approval updates to the manufacturing section of the approved applications (i.e., changes to the manufacturing process)
14029 Delete from the annual drug experience report the section which calls for any updates in the manufacturing; instead, submit biannual AAP updates (Alternative Administrative Procedure for submitting manufacturing chemistry changes) on minor changes and supplements to the New Animal Drug Application (NADA) for major changes
14039 Consider developing a nationwide post-approval monitoring program [re: antibiotic resistance]
14050 Clarify the process of developing enforcement strategies by the Office of Surveillance and Compliance and involve stakeholders
14059 Make international harmonization an important issue for the long term
14068 Redirect resources more towards surveillance and perhaps less toward the drug approval process
14075 Develop an appropriate monitoring mechanism to ensure violative residues do not occur in imported products
14080 Make enforcement a high priority, especially in the case of bovine spongiform encephalopathy (BSE), transmissible spongiform encephalopathies (TSE), and the rendering industry
14082 Collaborate with USDA to develop a fool-proof system to ensure animals that exhibit neurological disorders do not reach the food supply
14084 Focus strong enforcement and compliance activities on the industry's ne'er-do-wells
14087 Increase oversight of the field offices by headquarters
14088 Fully fund state programs under contract with GMP inspections
14089 Create a voluntary self-inspection program to ensure appropriate scientific infrastructure
14094 Place high priority on voluntary self-inspection programs for medicated feed establishments
14099 Focus on international issues, such as regulation of imported products and Codex, import inspections for safety and purity, food and feed safety standards
14101 Review the frequency of inspections; in a given period, some establishments are inspected three times while others are not inspected
14102 Focus inspections on food safety
14103 Work continuously to improve the safety of the food supply
14105 Set science-based feed safety standards
14107 Include safe manufacturing of feeds and accurate labeling, while guarding against contamination in the feed safety program
14108 Include manufacturing process controls in the safe production of medicated feeds
14109 Use voluntary self-inspection, or self-certification through self-inspection of manufacturing of animal feeds, with third-party involvement in certification and oversight
14110 Develop more coordination and/or understanding between state and federal programs regarding animal feed regulations
14111 Police fraud and mislabeling of animal feeds
14112 Use co-training programs when contracting with the states to improve inspection processes
15002 Use the Internet to help with international compliance issues
15003 Implement accredited formal training programs for members of the device industry who teach manufacturers what they need to do
15006 Partner with third parties to do routine inspections and allow FDA to concentrate more on its scientific role
15008 Partner non-critical conformance roles with third parties through accreditation by FDA
15010 FDA should continue to conduct postmarket studies at all costs. These studies cannot be privatized, and the public expects the Agency to have complete control over them
15011 Create a separately funded center, if necessary, for the analysis and coordination role of postmarketing studies
15012 Maintain a very strong handle on establishment registration, especially regarding international and transjurisdictional issues
15013 Include ISO 13485 in the ongoing accredited persons program for Quality System Regulation (QSR) inspections
15014 Develop a 2- to 5-year plan to move to a full QSR credit for ISO 13485
15015 Rethink the advent of conformity assessment bodies (CABs)
15016 Do not seek application of the HACCP process for device conformance
15022 Consider development of International Standards Organization (ISO) certification of companies by third-party review
15023 Streamline inspections so they are more focused, take less time, and so that the company understands FDA expectations
15024 Create an industry/FDA/User facility working group to look at the design (i.e., goal, vision, structure) of the Sentinel System and the funding strategies for it
15025 Utilize summary reporting to a greater degree for Medical Device Reports (MDRs)
15026 Streamline the postmarket surveillance program to have an achievable purpose and reduce the number of subject products
15028 Apply postmarket tracking to products that really require it based upon a validated risk model and seek stakeholder involvement when identifying these products
15030 Consider mechanisms for ISO certifications and/or an accreditation process for "controlling" not "conducting" the inspection process
15031 Include partial credit for ISO certifications in the accredited person program in order to level the playing field with foreign device manufacturers
15032 Consider having devices in lower risk categories be candidates for the first phases of devolution of inspection duties towards third parties in the accredited persons program
15035 Return to an adequate inspection program in the area of radiation control to protect the public health from unnecessary exposure (i.e., resurrect the States program)
15036 Develop a Mammography Quality Standards Act (MQSA) approach to other diagnostic radiological tests
15038 Consider the State radiation control programs' needs when re-engineering FDA-required reports
15043 Require physicians to report adverse device experiences
15050 Explore a process for the efficient capture and utilization of adverse event data by FDA and the clinical community
15057 Explore an incident reporting system operated by an outside agency (i.e., Federal Aviation Administration model) alongside and in addition to the sentinel reporting system
15060 Maintain the Federal Compliance Testing program for diagnostic x-rays
15066 Stratify inspections based upon past history of compliance of companies, degree of risk of the product, and various other elements that FDA has built into its plan
15075 Eliminate the inspection program for x-ray machines and put the onus on the facility buying the equipment to hire a medical physicist to inspect it and report the results to FDA
15083 Conduct follow-up studies on persons who have grandfathered devices to help identify any associated problems or symptoms
15085 Explore the idea of using real practitioners and ultimate end users, consumers in every form, to help evaluate incident reports
15086 Consider going for the full anecdotal story, not just a summary report, to allow analysis of patterns within the stories
15088 Monitor better what pharmaceutical industries put out and what they monitor
15089 Find qualified volunteers to help monitor what goes in inserts and on boxes.

FDAMA Objective: D

Ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1).

11001 Be a leader in food safety, (i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors)
11003 Adequately fund and staff research
11015 Develop program evaluation criteria and training to ensure consistency and uniformity in state shellfish programs
11018 Use science and fact-based risk assessments
11026 Perform research into the development and application of methods to quantify exposure and risk
11027 Use sound science and risk assessment when making decisions on prioritization of food safety issues
11028 Focus research efforts on emerging foodborne pathogens, quantitative risk assessment, practical detection methods, faster analysis, and identification of sources and the means of prevention of contamination in foods with pathogens
11029 Work cooperatively and fill gaps through resources outside the FDA
11039 Focus research on risk assessment and methods development, equally
11050 Reconstitute the Food Committee to increase its credibility and to include consumer activists for balance
11059 Continue consultation program for biotechnology products
11077 Focus on health-related product labeling, particularly updating standards of identity and review of health claims petitions
11078 Perform research or modeling in the areas of infectious dose for pathogens because zero tolerance does not always reflect the current scientific information
11085 CFSAN should continue work in risk assessment and international activities
11086 Establish a dietary supplement Advisory Committee
11087 Place a high priority on nutrient databases
11102 Adopt a science-based policy on health claims and labeling
12075 Fund new research for developing surrogate markers in fast-track diseases that have no surrogate markers at present
12158 Leverage access to other sources of information, such as working with the PBMs, to look at concomitant drug prescriptions
12160 Expand regulatory research on safety factors
12165 Continuously educate the Agency staff about state-of-the-art science, mentor new recruits, and retool senior staff
12166 Develop a program to bring academic scientists to the Agency
12169 Use national search committees when filling important positions
12170 Develop a sabbatical program
12171 Ensure that Advisory Committee members have the adequate skill level necessary
12172 Include at least one clinical pharmacologist and one biopharmaceutical scientist on every Advisory Committee
12173 Develop opportunities, as through sabbaticals, for the Agency, academia ,and the industry to share ideas
13004 Create a mechanism for the Agency to receive sound advice on scientific questions
13005 Convene a working group from the regulated industries to review present Agency use of Advisory Panels and make recommendations as to how the process might be improved to maximize their utility to the FDA
13010 Make regulatory decisions, including the development of guidance documents and regulations, on the best available science
13011 Work more closely with industry to identify research areas and review ongoing programs
13020 Conduct targeted research on regulatory policy, particularly if planned collaboratively with industry
13021 Provide in-service training that supports the skills of staff to conduct reviews of marketing applications
13022 Train field staff partly within pharmaceutical companies
13023 Collaborate with other regulatory agencies worldwide
13024 Establish periodic meetings for Division Directors in both CBER and CDER with up to four industry representatives on a bimonthly or quarterly basis to share scientific and technical information, management ideas, overall approaches, and creative thinking
13027 Give reviewers brief sabbaticals in the regulated industry
13033 Have CBER talk with CDER about the success of the program for brief sabbaticals in the regulated industry
13052 Conduct research in CBER for maintaining an appropriate scientific infrastructure
13066 Convene external advisory groups to help eliminate the differences where differences among regulatory policies exist between centers for similar projects (e.g., computer programs)
13067 Analyze the risks and benefits of the European community's policy toward blood processing solutions as device accessories versus drugs
13068 Continue international harmonization efforts until a single global dossier is recognized for all blood and plasma products, related drugs and devices
13075 Reevaluate requirements for participation, as appropriate, by national FDA staff in professional meetings that are sponsored by the regulated community or other non-government entities to allow for more participation
13080 Think more innovatively about creating a system for making quick changes to guidance documents as scientific and technical knowledge expands, without compromising the public input process
13085 Set up staff exchange programs with academia, other government agencies such as NIH, the Centers for Disease Control and Prevention (CDC), the National Science Foundation (NSF), and industry research organizations, to share staff expertise, and research results
13133 Use experts to evaluate the substantiation and the information, whether it is modeling, or meta-analysis
13134 Carry throughout the Agency CBER's model of using science as the basis for pulling together guidance documents and regulations
13153 Configure Advisory Committees to have consumer representatives as an essential component in the FDA regulatory process
13154 Continue to use consumer advisors
14003 Find ways to improve or fill human resource gaps in application review processes by seeking expert outside review of certain sections of the application
14004 Consider using outside expertise on statistical evaluation of efficacy studies
14012 Conduct transparent science-based discussions with stakeholders regarding the results of antimicrobial susceptibility monitoring programs and determining corrective actions
14014 Seek scientific input from external (non-FDA) groups and organizations in order to make sound decisions; develop a mini-working group to do this
14018 Use a public process to identify criteria for antibiotic approvals and the thresholds for antibiotic resistance
14019 Secure from the animal drug companies information as to the quantity of antibiotics sold in the U.S. by label
14021 Have consumer representatives sit at the table with the scientists and other stakeholders to define the criteria by which an antibiotic is approved and to identify thresholds for antibiotic resistance
14023 Seek to establish a database with complete and accurate (e.g., pounds of feed sold and active ingredient per pound) information to monitor microbe-related illnesses and trends in antibiotic resistance
14036 Correlate antibiotic use with developing resistance in order to make public health policy decisions
14051 Work closely with USDA and Agriculture Research Service, and cooperative extension to ensure that FDA's science needs are met
14063 Stand firm on science, including risk-benefit analysis, in evaluating submissions, in collaborative problem-solving, and in education
14064 Foster close relationships with USDA, research and education agencies to ensure science and technology transfer needs are met
14066 Focus on problem identification and problem solving, and technology transfer; the industry has quality assurance and monitoring programs
14067 Engage stakeholders and other government agencies regarding intramural research programs and funding
14069 Re-establish the pet food specialists in CVM
14086 Give enhanced training and education for the inspectors and reviewers, possibly through joint industry-Agency efforts
14105 Set science-based feed safety standards
14106 Devote necessary resources for development, or selection and validation where needed, of analytical methods for detection, especially of certain potentially high-risk feed contaminants in the name of feed safety.
14117 Update the capabilities of CVM's scientific reviewers
14118 Have the CVM Advisory Committee examine a broad range of issues, not just clinical
15004 Develop a subcontractor network for broadening scientific input
15005 Move some of the expert resources from non-critical inspection duties to serve on FDA advisory or other types of committees
15039 Revisit the structure and number of FDA Advisory Committees in order to increase the number of participants, broaden the committee's mission and increase the total number of committees
15042 Partner (i.e., non-regulatory) with radiological stakeholders to develop a more standardized, quality approach to medical imaging in order to achieve proper patient diagnoses
15058 Make consumer representatives on Advisory Panels an integral part of the process from the beginning
15062 Prepare the consumer representative on Advisory Panels for their role and be invested in helping them overcome the technical and cultural barriers
15069 Communicate more with professional societies and other organizations
15078 Review products on the merit of scientific evidence, safety and effectiveness, and not on politics as supported by adverse reporting statistics
15087 Develop a fund for public citizens to come and testify before Advisory Panels.

FDAMA Objective: E

Ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1).

11023 Streamline the process for approval of food and color additive petitions
11047 Promptly approve well-founded health claims that would promote an overall healthier diet
11056 CFSAN should conclude its review of GRAS petition 3G0016 regarding GRAS affirmation for many enzymes used in biotechnology
11058 Replace the resource-intensive GRAS petition process with a streamlined notification system
11061 Focus priority on the approval of new food additives and approval of additional uses of approved food additives
11063 Develop a simplified GRAS notification procedure, in addition to the current procedure
11064 Expedite the approval of appropriate nutrient content and health claim petitions and citizen petitions related to food labeling
11067 Significantly improve the food additive approval process to increase efficiency, predictability, and accountability
11092 Reform the food additive review process
11098 Initiate a pilot study by taking petitions or a threshold of regulation requests from the current backlog and processing them through the review portions of the proposed food contact notification program
12036 Finalize over-the-counter (OTC) monographs, with periodic reviews to update and clarify the finalized monographs pursuant to new technologies and drugs
12059 Assign highest priority for CDER and CBER to continue to expedite the development and review of new drugs for treating serious and rapidly fatal diseases such as ALS
12060 Make FDA guidance for fast-track diseases explicit
12061 Solicit recommendations for properties of fast-track diseases from both the American Medical Association (AMA) sections and specialty organizations, e.g. American Neurological Association, American Academy of Neurology, World Federation of Neurology
12062 Urge proper implementation of the FDAMA section on fast-track products to increase and expedite the availability of new therapies for ALS; ALS drug development has not benefited equally from accelerated approval
12063 Acquire substantial evidence of effectiveness for ALS drugs by permitting the use of phase IV post-approval conformance trials, and adhering to its own standards
12064 Reassess the need for controls in phase III for a disease such as ALS, which has no surrogate markers, but is relentlessly progressive and results in continuously cumulative physical impairments
12065 Consider approval based on efficacy relative to safety for ALS drugs, as with cancer drugs and immunosuppressive drugs for organ transplant
12067 Evaluate the efficacy of a drug or biological product for ALS in the fast-track approval process as for other life-threatening diseases
12074 Proactively plan the future drug approval process for fast-track diseases and formalize and implement those plans
12102 Work with industry to ensure the integrity of the clinical trial process
12111 Have an independent consumer-run organization, funded by pharmaceutical companies, to independently evaluate drugs advertised to consumers
12134 Make failure mode and effects analysis a requirement for all drug product approvals
12149 Ensure that all applications reviewed under the fast-track provisions of FDAMA be subject to all provisions of that section
12158 Leverage access to other sources of information, such as working with the PBMs, to look at concomitant drug prescriptions
12174 Develop a more formalized approach to prioritizing and examining the risk-benefit of certain drugs, such as the "lifestyle-modifying" and "me too" drugs
13017 Do not overreact to the small number of recent withdrawals by slowing down the process
13044 Use the Prior Approval Supplement (PAS) process only for novel products or for a first-time request to license an establishment or product
13048 Engage industry in a dialogue about the pilot program for approval of certain blood and plasma products through a monograph system
13053 Provide quicker patient access to improved blood products and technologies through shorter review times
13054 Provide quicker patient access to improved blood products and technologies through more constructive dialogue with CBER policy staff
13055 Reduce review times for blood-related drugs, devices and products to no longer than 6 months for any review cycle, not just fast track
13056 Create goals for review times for responses to warning letters or other enforcement topics (e.g., 10-30 days from industry followed by 2-3 months for FDA review)
13057 Relegate to market withdrawal status any blood or plasma recalls involving only hypothetical risks, technical deviations or small numbers of expired products
13058 Examine historical experience with the current error and accident reporting system before extending it to other areas
13060 Reduce the extent of prior-approval work for the addition of modified blood products (e.g., irradiated or leukocyte-reduced)
13062 Downgrade some changes to 30-day notice and annual report status
13063 Integrate approval processes for new blood product license supplements with drug and device clearances
13064 Expand the use of guidance documents and notifications to facilitate licensed blood center use of new technologies where the technology has a proven track record for many years, or where the benefits clearly outweigh the risks
13076 Expedite the rapid development and completion of the new protocol comparability process and other initiatives
13082 Think more innovatively about creating an innovative staff incentive/reward system that will foster new ideas and speedier reviews without compromising quality and effectiveness
13084 Create a tier for submissions and reviews based on hazard and impact
13090 Have a classification for meetings (e.g., A, B, C) with defined timelines (e.g., 30, 60, 75 days) for holding the meeting after the request
13093 Require pre-approval for a substantial change, a 30-day review period for a moderate change to a product (a supplement with a notice), and an annual report for a minimal change (notice)
13095 Develop specific guidance dealing with tests and acceptance criteria in the process for a comparability protocol
13096 Apply PDUFA II (Prescription Drug User Fee Act) performance goals that have been stated first to fast track
13097 Exceed the PDUFA II goals when it comes to fast track items
13098 Further clarify and develop the definition of "serious and life-threatening conditions"
13099 Clarify and develop the definition of "unmet medical needs"
13100 Make use of unvalidated surrogate end points subject to the post-approval requirements of subsection (b)(2), and do not create a new grouping of post-approval requirements for fast track
13101 Allow regular approval for fast tracks when using clinical or validated end points, and do not make them subject to the post-approval requirements of subsection (b)(2)
13102 Include discussion of the selection process for surrogate end points in guidance documents
13103 Focus attention on surrogate end points for chronic or degenerative type diseases that require longer or larger clinical trials
13104 Focus attention on surrogate end points that have broader applicability to a class of technologies such as with gene or cell therapies
13106 Provide recommendations and guidance in the surrogate end points guidance document with regard to dissemination of information on surrogate end points
13107 Provide authority to Division Directors for designating products as fast track
13108 Base withdrawal of fast track designation on sponsor demonstration, via a pivotal clinical trial, that it is no longer pursuing an indication for a serious or life-threatening disease
13109 Base withdrawal of fast track designation on a complete review of the NDA or BLA by an Advisory Panel and determination that a product does not meet an unmet medical need
13111 Allow a sponsor to request fast track designation at filing of the IND, during the process, or at filing of the NDA/BLA
13112 Meet with the sponsor within the first 60 days to begin dialogue about what all the requirements would be for an IND that receives a fast track designation
13118 Terminate pre-approval of marketing literature 6 months after the product has been approved unless the sponsor is demonstrating a pattern of inappropriate promotional activity
13136 Develop a uniform set of acceptance criteria for what subset analyses would look like from the industry so there are not differences between divisions
14006 Review requirements for new animal drug applications (e.g., section 514) and see if information that has been required in the past is no longer necessary and can be eliminated
14026 Consider outsourcing some reviewing of certain application sections, e.g., human food safety section
14027 Eliminate duplication in the review process, particularly in the Chemistry, Manufacturing, and Controls (CMC) section of the submission; simplify and streamline
14028 Simplify the post-approval updates to the manufacturing section of the approved applications (i.e., changes to the manufacturing process)
14029 Delete from the annual drug experience report the section that calls for any updates in the manufacturing; instead, submit biannual AAP updates on minor changes and supplements to the NADA for major changes
14035 Require manufacturers to submit sales data, checking the amounts of the various antibiotics used in species of livestock and make the data publicly available
14046 Streamline the Biometrics staff review and eliminate needless number crunching that causes inefficiency in the review process
14047 Refocus on the intent of the legislation behind the Animal Drug Availability Act (ADAA) and fulfill its mission statement, i.e., timely review through better communication and clarification
14048 Make delegation of responsibility to third parties an open process with stakeholder involvement
14053 Streamline the efficacy review process even more; it is still at odds with the reality of modern animal agriculture
14055 Make good use of the formal binding presubmission conferences to reduce backlogs and speed the approval process
14056 Establish an effective minor use/minor species program through administrative not legislative means
14058 Ensure implementation of ADAA by reducing the approval time, increase staffing levels, and providing adequate funding before raising the User Fee issue
14065 Use formal presubmission conferences
14070 Work with the industry and the aquaculture industry to increase the availability of aquaculture drugs
14071 Forward to Congress the proposal to increase the availability of approved animal drugs for minor species and minor use, as originally written by CVM
14074 Promote international drug harmonization for animal drug approvals
14079 Make new product availability a priority
14092 Emulate CFSAN's proposed GRAS notification system to sanction more feed products and ingredients
14093 Reduce the complexity of the drug review process
14098 Expedite review and action on citizen petitions filed by interested parties seeking changes in the Agency's rules or procedures, especially those concerning animal drug assays, liquid feeds, and GMPs
14114 Make efficacy studies flexible
15007 Transition to a European model for premarket approval over five years
15009 Adopt the identity of a competent authority to administer the role of third parties (notified bodies) for the market placement of devices
15029 Create an FDA/stakeholder working group to identify additional mechanisms to meet submission time frames
15037 Continue to offer FDA reviews as an alternative to third-party reviews
15070 Add more devices to the list for third-party review and make the process for using third-party review more clear.

FDAMA Objective: F

Eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

11062 Increase attention to the affirmation of long-pending GRAS petitions
11098 Initiate a pilot study by taking petitions or a threshold of regulation requests from the current backlog and processing them through the review portions of the proposed food contact notification program

Not Directly Related to a FDAMA Objective

11009 Give priority to product safety assurance and outreach, including the programs that support these activities
11010 Place high priority on programs that affect the health of the general population
11011 Place priority on research for alternative indicators; rapid methods for specific pathogens; biotoxin identification; and risk-assessment
11012 Place priority on international activities, especially the safety of imported thermally processed shellfish, the effectiveness of processing practices, and the adequacy of biotoxin monitoring in foreign countries
11013 Focus on food safety issues that relate to economic fraud
11017 Develop a uniform, consistent approach to address risks of public health significance
11019 Adopt flexible and responsive regulations that encourage research and innovation
11020 Recognize that industry is responsible for the integrity of its products
11021 Seek clear, consistent, and performance-based regulations
11024 Modify food standards that are out-of-date and inhibit innovation
11031 Focus on health contributions in the diet for maintaining health and preventing disease
11037 Make research and education the highest priority for CFSAN, in cooperation with academia and industry
11043 Keep the Food Safety Initiative (FSI) as the top priority
11044 Consider the health impact of the FSI programs
11045 Improve the nutritional quality of the American diet
11046 Improve nutrition labeling to include trans-fat on the label
11049 Build a record detailing the need for greater authority to protect the public from unsafe and misleadingly labeled products
11051 Do not let trade concerns supercede health concerns
11054 Impose registration fees on food manufacturers
11055 CFSAN should publicize the fact that it cannot adequately do its job without additional resources
11057 Finalize the GRAS notification regulation
11071 Give priority to the cosmetics and colors program
11072 Apply resources to programs that minimize consumer deception
11073 Obtain adequate research funding
11079 Place more resources on Codex participation and other international activities
11082 Approve irradiation of sprouts to eradicate Escherichia coli O157:H7 and Salmonella
11083 Approve more antimicrobials to help ensure food safety
11100 Require all fresh juice processors to pasteurize or otherwise process their products
11107 Consider requiring consumer research as a component of substantiation files for dietary supplements
11108 Place high priority on threshold of regulation determinations for food packaging and certificates of free sale
12030 Increase resources in CDER, place priority on MedWatch system, and better use the assets in the states to improve response to death and injuries from medicine
12033 Emphasize premarket reviews and strengthen postmarket surveillance through the use of the states resources and consideration of drug reporting similar to device reporting requirements
12034 Assign highest priority to continuing to improve the drug approval process and expedite removal of unsafe products
12035 Consider review of grandfathered drugs (e.g. ephedrine) that have never been subjected to the drug approval process
12037 Review grandfathered drugs, which could lead to improved monographs and result in much needed reclassification of some drugs
12038 Consider non-traditional drugs and their ethnic use in monographs or as a new category of medicines
12043 Modernize the public's and industry's expectation of FDA (and the state and local governments)
12044 Address FDA's ultimate responsibility to manage, and as necessary, reallocate resources to achieve statutory deadlines and other goals of FDAMA in a timely manner
12046 Don't overstate the responsibility and authority of FDA, as in the question posed, "How can we better assure that drug advertisements communicate appropriate messages?"
12054 Stress to Congress, the press, and public that current safety standards for new drug approval are significantly higher than in the past
12066 Develop surrogate markers for ALS
12076 Increase FDA's budget with the increase in NIH's budget
12085 Change the prescription blank, the drug order, that is given to pharmacists (especially to include intended use)
12086 Solicit public support for changes in the system (e.g., prescription forms)
12087 Get involved in the dialogue of the practice of medicine and pharmacy
12098 Have PhRMA work with the Consumer Federation of America to secure adequate funding to implement FDAMA in a way that will not compromise the safety of the public
12099 Have Congress give serious consideration to expanding the User Fee program
12100 Include safety goals in the FDAMA plan
12104 Don't allow postmarket activities to suffer because of premarket activities
12105 Fully exercise the role of regulator and protector by being our own strongest and most vociferous advocate for more resources
12142 Generate a realistic budget for meeting FDA's legislative mandate
12143 Work internally to ensure that FDA leadership seizes the opportunity given by Congress to document what resources the Agency needs to do its job
12144 Reassert FDA's role as a regulator with the primary responsibility to protect and promote the public health
12161 Reassess the risk-benefit analysis of lifestyle-modifying drugs
12167 Develop a program of time-limited tenure of division and office directors
12168 Use annual reviews that are quantitative and qualitative
12176 Develop a professional-judgement budget that provides the Agency's resource needs to meet its legislative mandate
13001 Use User Fees to address certain narrow programmatic problems
13002 Continue to use the appropriations process to address the public's overall interests about FDA's ability to carry out its functions
13003 Have senior management at FDA present its budgetary needs to both OMB and Congress in a realistic and forceful manner
13006 Identify outdated or vague regulations or guidance documents as early as possible
13025 Increase efficiency in the use of current resources
13026 Do not diminish the current level of full-time support staff paid through User Fees
13029 Have external Advisory Panels advise FDA on efficient administrative policies and activities
13030 Collaborate with industry as much as possible
   
13031 Analyze the number of INDs in the pipeline before User Fees
13032 Have one organization or a group of management consultants advise FDA on ways to structure some of the administrative changes that you are considering
   
13034 Disseminate information on new drugs via the Federal Register as well as the Internet
13035 Make reviewer handbooks, GRPs, etc., available as hard copy, at a price that includes all costs plus administrative fees
13036 Make GRPs, reviewer handbooks, etc., available in both electronic and hard copy, charging more for the electronic form
13042 Ensure that the paperwork reduction and regulatory efficiency goals of the BLA are maximized with its implementation
13059 Target "me too" sites and products for paperwork reduction
13061 Simplify and reduce reporting
13070 Continue the CBER open door and open telephone policies
13087 Search out ideas and innovations from other fields that might be applicable to the FDA system
13116 Apply subsection (b)(2) (alternative standards for marketing) to unvalidated data regardless of whether it was a surrogate or clinical endpoint
13117 Take other things into consideration in terms of safety and efficacy when the 95 percent standard is not met
13119 Make criteria for acceptable journal articles and reference texts less restrictive and more comparable to the criteria outlined in the statute itself
13121 Stress to Congress, the press, and the public that the current safety standards for new drug approval are significantly higher than they were in the past
13122 Leave it to the industry to ensure that the necessary information is included and do not have specific requirements as to where and how that information should be attached or presented
13123 Make OCA the Agency to give public responses to media events, much in the same way that they handled the situation with breast implants
13124 Expand the unapproved use definition to include information from sponsors' pivotal studies that were the basis for an approval
13126 Permit industry to include their Internet site address on a reprint and indicate that further information is included there
13127 Adopt as many of PhRMA's proposals as FDA finds acceptable because the Massachusetts Biotechnology Council endorses them wholeheartedly
13129 For formulary decisions, adopt a definition of healthcare economic information that includes cost analysis, cost effective analysis, and cost benefit analysis
13130 Permit manufacturers to use reasonable assumptions with the healthcare economic consequences derived from the approved indication, rather than just clinical end points
13131 For formulary decisions, allow economic information to be supported by clinical outcomes that include physiologic, anatomic ,and biologic end points; health status; quality-of-life measures; life expectancy; patient performance, satisfaction and compliance
13132 Permit industry to disseminate information in many different ways, using both printed material, computer-based material, interactive software, etc.
13135 Have a uniform personnel training program regarding changes associated with FDAMA
13139 Publish performance results on a more regular basis rather than perhaps periodically
13140 Measure the Agency's performance and allow the public to scrutinize both FDA's and industry's performance
13141 Expand the ombudsman's role to have the jurisdiction to go Agency-wide
13142 Allow the ombudsman's role to take a more proactive position in terms of hosting forums on some general issues the industry is having so that industry can collectively respond
13143 Revise the complaint review procedure
13144 Raise complaints issued against a particular reviewer to higher visibility and scrutiny
13145 Engage in data collection concerning supply as recommended by the HHS Advisory Committee on blood safety and availability
13148 Create a regulatory environment that keeps an eye on supply
13150 Remain keenly aware of the small number of manufacturers currently producing pooled-plasma derivatives and, in the case of the alpha-1 community that they are serviced by a sole supplier
13152 Have OCA work in conjunction with CBER in the arena of plasma derivatives
13156 Make certain that a national notification plan is implemented to the extent that FDA can
13157 Use the medical and scientific Advisory Committees of the plasma users coalition
13158 Address the issue of how much control FDA has over how much product the industry manufactures
13159 Try to understand the impact of a consent decree or warning letter as it relates to supply of product
13160 Consider the requirement of 1 kilo of material that is in short supply, where only 50 percent of patient needs are currently being met
13161 Figure out how to preserve the current more open, informal approach to the regulatory process
13166 Make sure that CBER reviewers and staff, especially the newer folks, really understand the importance of the open approach to communication and how it really can facilitate things in the end
14002 Direct resources to the drug approval process to maintain a system that is responsive and efficient in meeting statutory deadlines
14008 Do not consider user fees
14020 Prohibit the use of antibiotic growth promoters that are also used in human drug therapy or that may impact human health
14022 Enable the animal drug industry to make public their antibiotic sales information
14024 Call a ban on subtherapeutic use only for those antibiotics which are used in the treatment of human disease and those antibiotics that select for resistance in antibiotics used for humans
14025 Do not use User Fees because they will discourage supplemental applications for minor uses and minor species
14030 Adopt the World Health Organization's (WHO's) position and immediately terminate the uses of penicillin and tetracycline
14031 Ban the subtherapeutic use of tylosin and lincomycin
14032 Adopt the goal of having a systematic approach towards replacing growth-promoting antimicrobials with safer non-antimicrobial alternatives
14033 Do not approve for use in livestock important antibiotic classes such as fluoroquinolones that are life-saving in human medicine, especially when other antibiotics are available
14034 Require, when approvals for new antibiotics for livestock are granted, an automatic withdrawal of the drug from the market if harmful antibiotic-resistant bacteria levels are reached
14037 Make drastically reducing antibiotic usage a top priority of CVM
14038 Redirect FSI funding to help with under-funded priorities at CVM
14040 Make a major commitment to preserving susceptibility to antibiotics among human and animal pathogens
14041 Eliminate the uses of antibiotics that are least critical (i.e., subtherapeutics) and develop more non-drug solutions to growth promotion, prophylaxis and therapy
14044 Move prudently in the review of new antimicrobials for animals
14054 Make staffing decisions according to CVM's primary responsibility, i.e., to approve animal drugs and to monitor the compliance in their distribution and use
14057 Ensure the ADAA is implemented in a manner consistent with its passage before exploring the User Fee issue
14060 Put safety first, product quality second, then efficacy issues
14061 Use more regulatory approaches rather than legislative approaches for minor use/minor species
14062 Publish a document for public comment on the categorization of sheep as a minor species
14073 Address aquaculture's need for antibacterial compounds, antifungal compounds, parasiticides, extra-label use of medicated feeds for minor species
14081 Respond to the Atlantic Monthly article on BSE
14083 Become more informed about how the real world works in order to make better decisions
14090 Examine why some compounds that have very little or no impact on human health must go through rigorous testing
14091 Eliminate internal roadblocks to ADAA, including the expanding levels of review and regulation, to meet the spirit of ADAA negotiation and legislative effort
14100 Be a resource for other federal agencies involved in combating non-tariff trade barriers
15027 Improve communication between the Office of Surveillance and Biometrics and the Office of Device Evaluation
15034 Adopt the National Committee for Clinical Laboratory Standards (NCCLS) anti-microbial susceptibility testing break points which reflect current emerging resistance patterns and extend these determinations to CDER as well
15040 Collaborate within HHS to bring FDA's approval of devices together with the Health Care Financing Administration (HCFA) payment for patient use of the device
15045 Consider having the device and drug manufacturers pool money to fund scientific investigations that are free from conflict of interest
15051 Mandate that every breast implant and all devices that have not been FDA approved include in the informed consent that the device is not formally approved because the manufacturer has not provided such evidence and that FDA is concerned about health problems
15052 Mandate that all chemicals and catalyst residues used in implantable devices be listed in the informed consent along with toxicity information
15053 Mandate that informed consent forms must be given to potential implant candidates at initial consultation along with the mandatory FDA breast implant information update
15054 Mandate a 7-day cooling-off period between initial breast implant visit and date of surgery to give patients adequate time to receive information by mail, including accurate percentages of complication rates and disease rates
15055 Design and implement a supplemental information checklist on frequent complications and diagnosis on devices suspected of having a long latency period for ease of reporting and collection of data for statistical analysis
15056 Mandate that all manufacturers halt marketing and require recalls when good manufacturing practices are violated and until they are corrected
15059 Review carefully any third-party evaluation products
15061 Clarify any non-payment decision by HCFA for patient use of a device
15064 Link each task that FDA performs specifically to the risks prevented by that function and determine a cost-benefit ratio
15065 Align Agency resources with statutory functions
15067 Hire good people, get rid of the ones that aren't so good
15068 Use more consultants
15071 Work synergistically with industry and others, including patient groups and professional societies to help meet statutory obligations
15072 Focus activities on high payoffs for public health
15073 Allow non-FDA organizations to do some of the initial work in developing some of the required FDAMA products and reserve for FDA the role of reviewing, critiquing and modifying
15074 Identify statutory responsibilities that are no longer necessary
15077 Prioritize what is being asked of FDA, which is too much, meaning that some things just aren't going to get done
15079 Mandate that accurate percentages of complication rates and disease rates be included on informed consent forms for silicon breast implants
15080 Submit an application fee to ensure the FDA has appropriate funds to conduct testing on the product submitted for the FDA approval to independent labs
15081 Enforce fines to help establish funds to ensure FDA can conduct testing on products submitted for FDA approval
15082 Restrict products that were grandfathered in, halt new sales, and allow only replacement devices
15084 Allow FDA to have the names of persons who have participated in studies of grandfather devices.

FDA Plan for Statutory Compliance