2.2 HUMAN DRUGS

2.2.1 Program Description, Context, and Summary of Performance

The Human Drugs Program assures that all drug products for the prevention, diagnosis, and treatment of disease are safe, effective and properly labeled. This is accomplished through: prompt and efficient review of clinical research; taking appropriate and timely action on new drugs and their generic equivalents; assuring quality of drugs on the market; and minimizing adverse events associated with use of prescription and over-the-counter (OTC) medications. To meet these goals, FDA frequently consults with experts in science, medicine and public health and also coordinates with consumers, product users and industry.

The challenge of assuring drug quality, safety and effectiveness is an ongoing one. While continual growth in the technological complexity of new products promises great health benefits for a growing number of U.S. consumers, FDA must be vigilant in safeguarding their interests. This challenge frames the Agency's strategic goals:

• Reduce human suffering and enhance public health by providing quicker access to important, lifesaving drugs and assuring availability of safe and effective drugs.
• Prevent unnecessary injury and death to the American public caused by adverse drug reactions, injuries, medication errors and product problems.

Through the successful pursuit of these goals, FDA is providing health protection and promotion for the American public, from the inception of new drug concepts, through research, product development, manufacturing, marketing and consumption. The Agency's approach to achieving the strategic goals outlined above, as well as key performance goals that will move the Program in these directions, are outlined in the next sections.

FY 99 Program Accomplishments

The Human Drugs Program had numerous noteworthy accomplishments during FY 1999. Among these were the following:

FDA Modernization Act--The Agency asked for over 220 studies to be conducted in the pediatric population and has granted pediatric exclusivity to seven products. FDA published a final rule for OTC sunscreen drug products containing the active ingredients that can be used in these products as well as labeling and testing requirements. It provides for uniform, streamlined labeling for all OTC products intended for use as sunscreens to assist consumers in making decisions on sun protection. FDA approved two products under Fast Track for the treatment of HIV. FDA published a draft Memorandum of Understanding between the states and FDA regarding the distribution of compounded drug products. FDA reviewed the current system of labeling products for use in pregnant women and developed a more comprehensive and clinically meaningful approach.

New Drugs - FDA achieved remarkable success by far exceeding the progressively more stringent performance goals agreed to for each successive fiscal year under PDUFA. Approved under accelerated approval was Ziagen (in 5.8 months) for the treatment of HIV-1 infection in adults and children. FDA approved 11 new drug products and/or new indications for OTC marketing in FY 99.

Antibiotic Resistance - FDA developed an Antibiotic Resistance Coordinating Committee to address the growing problem of antibiotic resistance and its effects on drug development and regulation. Antibiotic resistance refers to the ability of infectious organisms to adapt to new environments. Bacteria may change their cellular structure to be able to survive the attacks of an antibiotic drug. Once bacteria become resistant to a drug, the drug is no longer effective in treating the infection. Some types of resistance also can be passed on to other bacteria so that a growing number of infections can no longer be treated with antibiotic drugs. Because it can affect so many people, resistance is a growing global concern and poses a major public health threat.

Bioterrorism - The Agency continued to develop regulatory policy options for stockpiling and using drug products that may be needed to respond effectively in the event of the deployment of biological weapons.

Generic Drug Review - FDA approved 198 abbreviated new drug applications. Of these, 40 represent the first time a generic drug was available for the brand name product. A first time approval was Ranitidine tablets (generic for Zantac).

Adverse Event Reporting System (AERS) - In FY 99, approximately 261,000 individual safety reports (ISRs) were received for entry into the AERS. FDA evaluates these spontaneous reporting data to identify any serious, rare, or unexpected adverse events.

Establishment Inspections - 773 domestic establishment evaluations were conducted for Good Manufacturing Practices (GMPs) compliance in support of New Drug Applications (NDAs).

Research - FDA continued to strengthen its science base by working with academia and industry to develop an efficient mechanism to conduct pharmaceutical research.

Outreach - FDA gave seminars on new drug therapies and labeling, made information available via the Internet, and established programs to make promising investigational drugs and therapies available to patients with serious and life-threatening diseases.

Electronic Submissions - FDA published guidance for the receipt and archive of full electronic NDAs. The Electronic Document Room was also expanded to manage the receipt and handling of full electronic NDAs.

2.2.2 Strategic Goals

Strategic Goal 1:

Reduce human suffering and enhance public health by providing quicker access to important, lifesaving drugs, and assuring availability of safe and effective drugs.

A. Strategic Goal Explanation

Approach

Approaches to achieving this goal include continuing efforts to meet or exceed mandated review times for new and generic drug application submissions. This will be accomplished through continued collaboration and cooperation with industry, academia, professional societies and health care organizations. FDA will also continue to compile detailed standards for evaluating drugs so that consistent and high-quality reviews are being performed - premarketing reviews continue to be subject to 100 percent quality control. This plan contains a goal pertaining to evaluating and tracking pediatric clinical trials FDA is requesting under FDA Modernization Act of 1997 (FDAMA) or requiring under the new Pediatric Rule. Section 111 of FDAMA grants drug sponsors additional market exclusivity for performing and submitting pediatric studies during drug development. These additional data will provide doctors with more complete information on how drugs affect children and make it more likely that children will receive improved treatment. Efforts towards achieving a totally electronic submissions environment will continue. In 1998 the equivalent of nearly 10 million paper pages in electronic format were received. Beginning in 1999, drug companies could submit an entire NDA electronically.

Research and Standard-Setting Contributions

FDA must maintain the scientific and technical expertise needed to keep pace with current advances in science and technology. FDA scientists must operate from a strong internal research platform to successfully work with the larger scientific community. Strong research is necessary to provide information on emerging technologies that will result in new products requiring review. Examples of where the Agency must keep abreast of current scientific developments are new uses for botanicals and new areas of risk such as antimicrobial resistance. To accomplish this, FDA will create scientific exchange programs with academic institutions and continue research collaborations such as the Product Quality Research Initiative (PQRI). Collaborations such as these are a method of leveraging external scientific expertise with that of the Agency.

FDA must be proactive in assuring that current and sound science underlies regulatory requirements, while at the same time allowing flexibility to industry to use innovative approaches in product development. FDA will continue to develop and finalize guidances that define its thinking about best practice approaches to address product development and monitoring standards, and provide recommendations to pharmaceutical sponsors and FDA reviewers about how to assure safety, efficacy, quality, and appropriate labeling.

Leveraging/Communication

FDA's ability to provide expeditious drug review is dependent upon enhanced collaboration and cooperation with industry, academia, professional societies and health care organizations. Agency scientists must maintain close communication with product sponsors throughout the product research and development phase. The ability to address problems early in the process prevents larger, costly difficulties and delays from occurring later in the review. This is, in essence, realizing major health benefit gains for a relatively small up-front investment. Additionally, opening access to outside expertise is an excellent way to leverage the Agency's limited science resources and apply the expanded knowledge when it is relevant in the review process.

Reinvention

The Agency is reinventing a critical area of its premarket review process as it relates to drug products affecting children under provisions of FDAMA and its new pediatric rule. FDA also continues to improve the efficiency of the premarket review process through its automation initiative. By the end of FY 00, the Agency will be able to process 75% of all review documents by implementing an electronic document management system throughout new drug review divisions. This should increase to 90% by the end of FY 01. FDA will also be able to receive about one quarter of all abbreviated new drug applications (ANDAs) electronically by the end of FY 01.

C. Goal-by-Goal Presentation of Performance

1. Review and act on 90% of standard original NDA submissions within 12 months of receipt (70% within 10 months); and 90% of priority original NDA submissions within 6 months. (12001)

• Context of Goal: A major objective of the human drugs program is to reduce the time required for FDA's review of all drugs, with emphasis on the review of new drugs that are intended to treat serious or life-threatening diseases, such as AIDS, AIDS-related diseases, and cancer; and those products that demonstrate the potential to address unmet medical needs.
• Data Source: Center-wide Oracle Management Information System (COMIS); New Drug Evaluation/Management Information System (NDE/MIS)
• Performance: Children and adults with HIV-1 infection, people with cancer, meningitis and antibiotic-resistant infections all benefited from timely reviews of significant new drugs approved in FY 99.

  For all open cohorts during FY 99, CDER took 185 actions on NDAs, 77 of which were approvals. The median approval time was 11.9 months, a 1% decrease in median approval time compared with FY 98. Final on-time performance information for the FY 99 submission cohort is not yet available but FDA expects to exceed its targets.

2. Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule; conduct research initiatives and activities to define the quality of the clinical studies, usefulness of data generated from these trials, changes in drug product labeling and resultant public health benefits for children. (12026)

• Context of Goal: FDAMA enables FDA to Issue Written Requests (1) for pediatric studies prior to approval of an NDA if FDA has determined that information related to the use of the drug in the pediatric population may produce health benefits and (2) to holders of approved applications for pediatric studies if it has determined that information related to the use of the drug in the pediatric population may produce health benefits. FDAMA also requires FDA to develop, prioritize, and publish a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric populations and update it annually.

  FDA issued a regulation (effective April 1, 1999) requiring pediatric studies of certain new and marketed drug and biological products. Most drugs and biologics have not been adequately tested in the pediatric subpopulation. As a result, product labeling frequently fails to provide directions for safe and effective use in pediatric patients. This rule partially addresses the lack of pediatric use information by requiring that manufacturers of certain products provide sufficient data and information to support directions for pediatric use for the claimed indications.

• Data source: Pediatric Exclusivity Database and the Pediatric Page database. (Database enhancements required to meet goal.)
• Performance: This goal is a new commitment for FY 01; therefore there is no report on a specific FY 99 target. FDA took several actions to implement portions of FDAMA that make it more likely that children will receive improved treatment. The Agency issued guidance to assist drug companies planning to conduct pharmacokinetic studies in pediatric populations so that drug products can be labeled for pediatric use. FDA reviewed over 150 proposed Pediatric Study Requests, issued over 100 Written Requests asking for over 220 studies to be conducted in the pediatric population and has granted exclusivity to 7 products. The FDA pediatric Advisory Subcommittee met to discuss important neuropharmacological and controversial ethical issues that have arisen. The Agency formed a Working Group to begin examining products granted exclusivity, data generated from pediatric clinical trials and any resultant changes in product labeling. FDA developed an interactive pediatric web page to provide detailed information to the public regarding FDA's pediatric initiatives.

3. Review and act upon 60% of fileable original generic drug applications within 6 months after submission date. (12003)

• Context of Goal: An important part of FDA's mission is to assure that safe and effective generic drugs are available to the American people. FDA has approved several thousand generic drugs that have been used successfully by millions of patients. The use of these products has resulted in substantial savings to consumers and the Federal government (Medicare and Medicaid).
• Data source: COMIS; NDE/MIS
• Performance: FDA does not expect to meet its FY 99 target. Beginning in January 1997, FDA implemented a procedure to reduce approval times by allowing reviewers to utilize a "facsimile" amendment. Facsimile amendments are requests from reviewers to applicants for clarification/resolution of minor deficiencies (e.g., resubmission of illegible pages or typographical errors). These requests do not close the review of ANDAs and the subsequent amendments/responses are the reviewers' highest priority. This procedure results in review times exceeding 6 months, but shortens overall approval times (a figure FDA believes to be more important than the 6-month goal).

The inability of FDA to meet the 6-month goal is also a function of the existing backlog of chemistry and microbiology reviews. To address the chemistry backlog, FDA restructured its chemistry review process by adding one additional team (and team leader) to each review division. Additional project managers were hired and assigned to the new chemistry teams. Also, all chemistry vacancies are in the process of being filled. To address the microbiology backlog, FDA assigned a project manager to the microbiology team to monitor the work progress and assign priorities. FDA also named a microbiology team leader and hired two additional reviewers and are in the process of hiring a third. FDA believes that these initiatives will reduce the chemistry and microbiology backlog allowing reviewers to get to the applications sooner and lessen the effect of the facsimile amendments on the 6-month review goal. With the new changes and procedures in place, FDA expects performance to be 40% by the end of FY 99, 45% by completion of FY 00 and 50% by the end of FY 01.

During FY 99, FDA approved 198 ANDAs. Of these, 40 represent the first time a generic drug was available for the brand name product. FDA also issued 68 tentative approvals in FY 99 compared to 19 in FY 98. The table below demonstrates how the reduction in the number of review cycles, combined with other initiatives, have reduced approval times.

MEDIAN APPROVAL TIME
Abbreviated Applications

4. Review and act on 90% of complete NDA applications resubmitted following receipt of a non-approval letter, within 6 months after resubmission date. (12002)

• Context of Goal: Resubmissions are responses provided by a pharmaceutical company to questions or deficiencies raised by FDA in an approvable or not approvable letter on an original application.
• Data Sources: COMIS; NDE/MIS.
• Performance: Final on-time performance information for the FY 99 submission cohort is not yet available but FDA expects to exceed this goal. For the FY 99 submission cohort, 60 resubmissions were submitted for review. This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

Fiscal Year 1998 Cohort as of 9/30/99

5. Review and act upon 90% of standard efficacy supplements within 12 months (30% within 10 months of receipt) and priority efficacy supplements filed within 6 months of receipt. (12004)

• Context of Goal: Efficacy supplements are requests from drug companies to add a new use or a new group of patients to be treated with an already approved drug. They often represent important new treatment options.
• Data sources: COMIS; NDE/MIS.
• Performance: Adults with HIV infection, people with cancer, diabetes, arthritis and other conditions all benefited from timely reviews of efficacy supplements approved in FY 99. Additional information on these new medication options follows:
• Norvir, for use in combination with other antiretroviral agents, for the treatment of HIV-infection.
• Doxil, for the treatment of metastatic carcinoma of the ovary.

Final on-time performance information for the FY 99 submission cohort is not yet available but FDA expects to exceed this goal. For the FY 99 submission cohort, 140 efficacy supplements were filed. This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

6. Review and act upon 90% of manufacturing supplements within 6 months and act on 30 percent of manufacturing supplements requiring prior approval within four months. (12005)

• Context of Goal: Manufacturers must notify the Agency in advance of certain manufacturing changes in the form of "manufacturing supplements" to new or generic drug applications. Review of these applications in a timely manner is necessary to assure that any manufacturing changes do not adversely effect strength, identity, quality, purity or potency of the drug product.
• Data sources: COMIS; NDE/MIS.
• Performance: Final on-time performance information for the FY 99 submission cohort is not yet available but FDA expects to exceed this goal. For the FY 99 submission cohort, 1,468 manufacturing supplements were filed. This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

7. Continue to achieve capability and capacity for electronic submission and archiving of information required to submit NDAs and ANDAs. (12008)

• Context of Goal: In 1998, electronic submissions offset the equivalent of nearly 10 million paper pages. Beginning in 1999, drug companies were able to submit an entire NDA electronically in lieu of paper.
• Data Sources: Electronic Document Room records.
• Performance: FDA published two guidance documents on the receipt and archive of full electronic NDAs. The Electronic Document Room was expanded to manage the receipt and handling of full electronic NDAs, additional workshops were conducted to assist industry in preparing their electronic submissions, and classes were held for FDA reviewers to train them on how to use the electronic documents. Approximately 40% of original NDAs received in FDA now include guidance-compliant electronic submissions. During the period January 1999 through September 1999, FDA received 36 NDAs that included some electronic components and 9 full electronic NDAs. FDA published guidance provides assistance to applicants submitting ANDA data in electronic format. During fiscal year 1999, FDA received 46 electronic submissions for bioequivalence and 69 for chemistry, manufacturing, and controls. FDA expanded its electronic document management system and, as of December 1999, approximately 47,000 review documents have been filed using the system. This system gives reviewers the capability to electronically capture, sign, and archive their regulatory review products.

This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

Strategic Goal 2:

A. Strategic Goal Explanation

Approach

FDA uses a number of postmarketing risk assessment approaches to ensure the continued safe use of drug products. The Agency's current adverse event database for drugs and therapeutic biological products, the AERS, contains approximately 2 million reports. In FY 98, more than 230,000 reports of suspected adverse events were received by the AERS. FDA evaluates spontaneous reporting data from the AERS to identify any serious, rare, or unexpected adverse events or an increased incidence of events. Based on its evaluation, FDA may decide to disseminate risk information, such as Dear Healthcare Professional letters, and may initiate regulatory action. Through a program called MedWatch, the FDA Medical Products Reporting Program, healthcare professionals and consumers are encouraged to report serious adverse events and product problems to FDA, the manufacturer, or both. FDA's Drug Quality Reporting System (DQRS) receives reports of deviations from Good Manufacturing Practices that occur during the manufacturing, shipping, or storage of prescription or OTC drug products. FDA receives medication error reports on marketed human drugs and maintains a central database within the DQRS and the AERS for all reports involving a medication error or potential medication error. The Agency puts substantial effort into reviewing medication error case reports to identify serious or potentially serious outcomes that might be avoided by modifying the labeling or packaging.

Research and Standard-Setting Contributions

FDA experiences continuous pressure for speedier approval of new products that hold the promise of new cures or symptom relief. The availability and increased use of medications also raises concern about the nearly inevitable circumstance that, after a drug is placed into general practice, harmful side effects will emerge that were not observed during pre-market investigations. Some side effects may be predictable but many are not. FDA has instituted a comprehensive postmarketing review system for identifying, evaluating, dealing with and possibly preventing adverse drug reactions. Additional research is needed on problem identification and reporting, and better methods of educating medical professionals and consumers on recognizing and reporting medical product problems should be implemented.

Information to support the science and technical positions of a guidance must be located or developed, and then analyzed carefully to allow an optimal set of recommendations to industry sponsors and Agency review staff. To extend Agency resources and incorporate the expertise of stakeholders into developing the information needed to establish policy, FDA supports collaborative efforts with extramural constituencies. Two recent examples include the PQRI and the Collaboration for Drug Development Improvement (CDDI). The PQRI focuses on product quality and the CDDI focuses on safety and efficacy. Both initiatives include stakeholders from the pharmaceutical industry and academia.

A safe medical product is one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available. Research, and as a part of that, the development of standards and guidances has a major impact on the benefits of taking the drug as opposed to the level of risk.

Leveraging/Communication

FDA draws on outside resources to strengthen its ability to assure the quality and safety of approved drugs. Research collaboration is an excellent method of leveraging external scientific expertise with that of the Agency. A prime example is the PQRI, a nonprofit foundation that serves as a vehicle for FDA, industry and academia to collaborate on key issues in pharmaceutical product quality through research and expert group analysis. (See performance goal 5.)

Many examples of leveraging exist in the Agency's compliance activities. FDA works with regulatory scientists in state and local organizations as well as national and international experts. Industry has widely participated in FDA-sponsored workshops to explain safety issues. One example is FDA's informal partnership to share test methods and procedures for drugs with regulatory scientists in the United Kingdom, Germany, Australia, Canada and the Netherlands. Combining samples has allowed the FDA to assemble a database of pharmaceutical ingredients, which serves as a reference in stopping the use of counterfeit drug ingredients. FDA has also worked with industry in technical workshops on laboratory testing of drugs.

The Agency looks upon consumers as partners in safe drug use. Communication is a critical element in managing risk associated with approved medical products. FDA has measured the usefulness of drug label information to the consumer and redesigned the label for OTC drugs, with prescription labels to follow. In partnership with national consumer organizations, FDA is disseminating educational information to consumers and health professionals about choosing the right medications, taking medications correctly and reporting adverse reactions (See performance goal 8). More drug information targeted to consumers is being made available on the Agency's website. "Take Time to Care" is an outreach program directed to women about the safe use of medications. In cooperation with over 80 national organizations, including the National Association of Chain Drug Stores, FDA expects to reach 6.5 million women and positively affect their use of medications.

Reinvention

FDA has increasingly used Agency-industry workshops to address safety issues in specific product areas, partnerships with state regulatory agencies, and research-oriented groups to expand the knowledge base. FDA field offices are encouraged to develop pilot programs in a continual effort to increase safety for consumers in the most effective, efficient manner and successful pilot programs have been adopted by the Agency.

Reinvention-oriented pilot programs have also been used in the surveillance area across the Agency. Development of sentinel sites has been a pilot program in the Medical Device Program, and offers a benefit to consumers and health professionals to be expanded to cover the Human Drugs Program.

C. Goal-by-Goal Presentation of Performance

8. Expedite processing and evaluation of adverse drug events through implementation of AERS which allows for electronic periodic data entry and acquisition of fully coded information from drug companies. (12007)

• Context of Goal: FDA's current adverse event database for drugs and therapeutic biological products, the AERS, contains approximately 2 million individual safety reports (ISRs). FDA evaluates spontaneous reporting data from the AERS to identify any serious, rare, or unexpected adverse events or an increased incidence of events. When a signal of a potential adverse reaction is detected, safety evaluators consult with product reviewers, medical officers, and epidemiologists to review available data and consider further options. FDA may decide to disseminate risk information, such as Dear Healthcare Professional letters, and may initiate regulatory action.
• Data source: AERS
• Performance: The AERS has been operational for nearly two years. In FY 99, approximately 261,000 ISRs were received for entry into the AERS. In November 1998, FDA published an Advanced Notice of Proposed Rulemaking for Electronic Reporting of Postmarketing Adverse Drug Reactions that would require manufacturers of marketed human drugs to submit ISRs to the agency electronically. The proposed rule would help harmonize reporting of postmarketing safety information worldwide and expedite detection of safety problems for marketed drugs, thus enhancing FDA's ability to protect and promote public health. A pilot program for electronic submission of ISRs was conducted involving manufacturers with approved products. In addition, FDA developed and piloted an AERS data retrieval system to provide reviewers with quick access to the AERS data and reduce their reliance on hard copy reports.

9. Initiate all research programs approved by the PQRI Steering Committee in FY 00 and complete 50% of the projects initiated in FY 99 under the auspices of the PQRI, a collaboration among FDA, industry and academia established to provide a scientific basis for policy and guidance development in CDER on issues of drug product quality and performance. (12016)

• Context of Goal: The PQRI represents a unique collaboration that brings together scientists to identify and/or develop best practices for manufacture of quality pharmaceuticals products. The information generated by the PQRI will provide CDER, for example, additional means for identifying "low" and "high risk" product development and manufacturing practices, enhancing its efficiency in responding to new and complex drug delivery systems and rapidly changing manufacturing technologies, and developing science-based policies in the areas of biopharmaceutics, chemistry, manufacturing, and controls. This research initiative will support regulatory policy and guidances for the types of product quality information that should be submitted to the Agency in drug approval requests.
• Data source: Office of Testing and Research Research Plan; "A proposal - PQRI;" Memorandum of Agreement between FDA and the American Association of Pharmaceutical Scientists; and "Proposed Operating Principles for the PQRI."
• Performance: This goal is a new commitment for FY 00; therefore there is no report on a specific FY 99 target. No projects were initiated in FY 99. Eleven projects are awaiting approval of the PQRI Steering Committee for initiation in FY 00.

10. Inspect 28% of registered human drug manufacturers, repackers, relabelers and medical gas repackers. (12020)

• Context of Goal: This goal measures performance for the statutory inventory of drug establishments for which inspections are required biennially. The total drug inventory is 19,749, of which 33 percent, or 6,509, are statutory. Inspections to accomplish this goal may be done by FDA directly, or through state contracts or partnership agreements. Achievement of this goal relies on the willingness and ability of the states to contract with FDA to inspect a large portion of the medical gas repacker industry. To implement these contracts, FDA's experience predicts that a significant investment in training and time is necessary to ensure quality and uniformity of inspections.
• Data source: Program-Oriented Data System, Official Establishment Inventory
• Performance: FY99: 26%. The data used to determine performance is a fiscal year data estimate derived from 2-year coverage data. Two-year coverage is computed by dividing the number of establishments inspected in the last 2 years by the total number of registered establishments. The fiscal year baseline estimate is half this number.

11. Assure the FDA inspections of domestic drug manufacturing and repacking establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements. (12006)

• Context of Goal: Conformance rates estimate the post-inspection status of the establishments inspected in the given year. They are based on the number of establishments inspected, the incidence of serious deficiencies detected (Official Action Indicated), and statistical data of deficiency corrections. Since firms inspected are not randomly selected from the entire population, the rates should not be applied across that population. However, as coverage of the inventory of firms is improved the rates will better represent the overall status of the industry sector.
• Data source: FDA Field Data Systems
• Performance: FY 99: 95%; FY 98: 96%; FY 97: 95%. Conformance rates for FY 97, FY 98 and FY 99 have been adjusted to reflect the observed average correction rate for each year.

12. Make available to consumers and health professionals more easily-understandable information on choosing and taking prescription and OTC drugs to prevent and reduce their misuse, take more of an activist role in how consumers use these drugs, and improve drug risk management, analysis, and communication procedures. (12027)

• Context of Goal: There is increasing public recognition that marketed drugs can lead to harm as well as benefit. Drug-related injuries and deaths can be reduced by creating a more educated public through expanded outreach activities and collaborative efforts with academia, professional societies and health organizations.
• Data sources: Approval Letter for new and generic drugs and the Labeling Text or Final Printed Label (FPL) for new drugs; Consumer Drug Information Sheets for New Molecular Entities (NMEs); Availability of FDA's reviews of new and generic drugs via the internet; Prescribing Information Sheet for NMEs. Report to the FDA Commissioner - Managing the Risks from Medical Product Uses, An Assessment of FDA's Approval and a Look to the 21st Century.
• Performance: This goal is a continuation of FY 99 and FY 00 Agency activities regarding providing more easily-understandable and -accessible drug information to interested individuals and organizations. It incorporates the FY 00 goals 12012 and 12025. There is no commitment to a specific FY 99 target and therefore no FY 99 report.

Partnerships between FDA and several non-profit agencies resulted in publication of four brochures on the appropriate and safe use of medicines. Public and advisory committee meetings were held to inform consumers and health care professionals about the Agency's work on making the pregnancy section of labeling more useful. FDA used the Internet to publish information on new and innovative drugs approved since January 1998. FDA's CDER website had 250,446 visitors.

13. FDA will: (a) evaluate the availability, quality and usefulness of prescription drug information provided to 75% of individuals receiving new prescriptions; and (b) complete two studies that will aid in development of comprehensive drug information. (12009)

• Context of Goal: According to legislative mandate, by the year 2000, 75% of all consumers receiving new drug prescriptions will also receive useful information about their medicine; in the year 2006, 95% would receive such useful information with their new prescriptions. In accordance with this mandate, FDA sponsored a process that resulted in a collaborative group of private-sector organizations drafting an Action Plan to achieve these mandated goals.
• Data Sources: Keystone Center
• Performance: The Agency is developing a proposed rule for prescription drug labeling and various labeling guidances. The goal is to make prescription drug labeling easier to access, read and use. Public and advisory committee meetings were held to inform consumers and health care professionals about the Agency's work on making the pregnancy section of labeling more useful. The 1998 National Telephone Survey was completed. The results for written information indicate that in 1998, 70% of Americans received written information about their prescription medications that is longer than a brief sticker label, compared with 67% in 1996, 54% in 1994 and 24% in 1992. A Risk/Benefit Communication study of gender differences in risk communication was completed; publication is anticipated in early 2000. This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

14. FDA will continue to improve the legibility and clarity of OTC drug labels, and improve the consumer's ability to read and understand important warnings and usage directions. (12010)

• Context of Goal: Each year, Americans purchase five billion OTC drug products for a wide variety of ailments, ranging from headaches to arthritis to sore throats. Although OTC drugs are generally very safe, their misuse causes hospitalizations each year. Studies estimate that half of these hospitalizations could be prevented by better consumer education and information.
• Data Sources: OTC Labeling Provisions; results of labeling studies.
• Performance: FDA issued a final rule establishing a standardized format and standardized content requirements for the labeling of OTC drug products. This final rule is intended to assist consumers in reading and understanding OTC drug product labeling and in using these products safely and effectively. It requires all OTC drug products to carry the new, easy-to-read format and the revised content requirements within prescribed implementation periods. FDA developed a public education campaign to help consumers understand how the new labels can be used to learn more about OTC medications. This educational campaign includes print and radio public service announcements, consumer brochures, point-of-purchase posters and other exhibit materials. FDA worked in partnership with national health and professional organizations such as the Nonprescription Drug Manufacturers Association to disseminate this information across a wide range of education networks. This FY 99 goal is included for reporting purposes. The goal does not continue into FY 00 or FY 01.

2.2.3 Verification and Validation

A preliminary assessment for data completeness, accuracy, and consistency and related quality control practices was done for each performance goal. The purpose of the assessment was to determine if the data was of a sufficient quality to document performance, whether the data was appropriate for the performance measure and if it was considered sound and convincing. Assessments will be use to determine the need to conduct further program evaluations.

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