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FDAAA Implementation - Highlights Two Years After Enactment


The passage of FDAAA greatly increased the responsibilities of FDA as well as provided FDA with new authorities and reauthorized several FDA critical programs. FDAAA reauthorized the Prescription Drug User Fee Amendments of 2007 (PDUFA) (Title I), the Medical Device User Fee Amendments of 2007 (MDUFA) (Title II), the Pediatric Research Equity Act of 2007 (PREA) (Title IV), and the Best Pharmaceuticals for Children Act of 2007 (BPCA) (Title V). New pediatric medical device provisions were enacted in Title III as the Pediatric Medical Device Safety and Improvement Act of 2007. An expanded clinical trials database was enacted in Title VIII which requires greater FDA involvement in ensuring that clinical trials information is provided to the National Institutes of Health (NIH) ClinicalTrials.gov.

FDAAA, particularly Title IX, provides FDA with additional requirements, authorities, and resources with regard to both pre- and postmarket drug safety including the authority to require postmarket studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies (REMS). FDAAA requires increased activities for active post market risk identification and analysis. FDAAA, Title X, requires new reporting of adverse events related to food and new regulations for pet food labeling, ingredients, and processing standards. 

In the second year of implementation, FDA continues to implement FDAAA as part of its public health mission. FDA has held numerous public hearings and meetings to address patient, consumer, health professional, and industry questions about implementation of specific provisions, particularly Title IX and Title X. FDA has issued various rulemakings and guidances on FDAAA provisions. FDA is committed to ensuring FDAAA efforts are transparent. A public implementation chart of specific statutory requirements can be found at http://www.fda.gov/RegulatoryInformation/Legislation/

The following list details the highlights of FDA’s implementation activities in the two years since enactment. 

FDAAA Implementation – Highlights Two Years After Enactment 

Title I – Prescription Drug User Fee (PDUFA) Amendments 

  • Prescription Drug User Fee Rates for Fiscal Year (FY) 2008, FY 2009, and FY 2010, published October 12, 2007, July 31, 2008, and August 3, 2009.
  • IT Planning per PDUFA goals letter – underway. Public meeting held October 19, 2007. 
  • New CDER employees hired ~ 685 since October 2008 (430 new hires). New CBER employees hired ~ 129 since October 2008. From January 1, 2008 to September 30, 2008 101 (64 new hires). 
  • Notice of Availability: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan. (Posted May 5, 2008) 
  • Prescription Drug User Fee Act IV Drug Safety Five-Year Plan (Draft). (Posted April 1, 2008) 
  • Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan. (Posted January 4, 2008) 
  • Draft concept paper for pilot study for industry to conduct their own name reviews in supporting their submission to the Agency posted for comment “PDUFA Pilot Project: Proprietary Name Review.” Discussion at June 5 and 6, 2008 meeting. Final concept paper Federal Register (FR) notice published October 7, 2008. Draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, published on November 24, 2008. FR notice published December 23, 2008 to obtain public comment on the information that will be collected under the PDUFA pilot project as required under the Paperwork Reduction Act. 

Title II – Medical Device User Fee (MDUFA) Amendments

  • Medical Device User Fee Rates for FY 2008 published October 2007; updated fee rates published August 2008 (for FY 2009) and August 2009 (for FY 2010).
  • Guidance for Industry, Food and Drug Administration, and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification; published October 23, 2007; foreign businesses can now qualify as “small,” resolving EU and NAFTA concerns. Revised editions published in August 2008 (for FY 2009) and August 2009 (for FY 2010). 
  • FDA now publishes an annual notice in the FR directing the public to a list of medical device guidance documents we are considering for development in the upcoming fiscal year, and we have established a public docket for the submission of comments. We published the first notice and list for FY 2008 in October 2007, and published an updated version for FY 2009 in September 2008 (FY 2010 edition is forthcoming). 
  • Implemented electronic registration and listing (R&L) for medical device establishments and products; this contributed to successful effort to update/correct R&L records — 13,700 establishments were identified as inactive during FY 2008. 
  • Medical device establishment registration fees, established by FDAAA met the statutory threshold for FY 2008, amounting to more than $26.6 million. Section 738(c)(2) of the FD&C Act required FDA to determine whether registration fee receipts for FY 2009 would meet the statutory threshold, and, if not, to adjust the registration fee rates for FY 2010 – FY 2012. We concluded that registration fees for FY 2009 meet the statutory threshold, and in the August 3, 2009 FR notice on fee rates for FY 2010, we announced that no adjustment of the registration fee was required.
  • To meet new performance goals for FY 2008 – FY 2012, both FDA and regulated industry agreed that FDA should develop an interactive review process to encourage and facilitate communication between FDA staff and industry during the review of medical device premarket submissions. To implement the new process, we published Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (December 2007, updated February 2008). Staff are now trained and interactive review is our standard operating procedure. 
  • Publication of additional guidance documents is required by FDAAA or the FDA Commitment Letter. During FY 2008 and FY 2009, we published several significant guidance documents:
    • Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses (February 2008). 
    • Expedited Review of Premarket Submissions for Devices, updated to reflect FDAAA (February 2008). 
    • FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment; (June 2008); explains how FDA and industry actions affect MDUFA performance goals. 
    • Draft Guidance on Diagnostic Imaging Devices Used with Approved Imaging Contrast Agents or Radiopharmaceuticals (September 2008). 
    • Assay Migration Studies for In Vitro Diagnostic Devices (January 2009). 
    • Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA (January 2009). 
    • FY 2010 Medical Device User Fee Small Business Qualification and Certification; (August 2009); this annual guidance explains how to qualify for small business fee rates and fee waivers. 
    • Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA, (January 2009). 
  • Held a public meeting in February 2009 to obtain information to help FDA better understand the issues involved in the establishment of a unique device identification system (UDI system). This meeting was an essential step in FDA’s development of UDI system, as required by section 519(f) of the FD&C Act (added by section 226(f) of FDAAA). (FR notice January 15, 2009).
  • Quarterly meetings with industry; we are now publishing the agenda and all FDA materials on our website simultaneous with the start of each meeting. 
  • Provided first annual report on CLIA waiver review times, as required by the FDA Commitment Letter (May 2009). 
  • Provided first annual report on medical device performance under FDAAA (report covered FY 2008). 
  • Provided first annual report on medical device user fees (financial report) under FDAAA (report covered FY 2008). 

Title III – Pediatric Medical Device Safety and Improvement Act 

  • Draft Guidance to institutional review committees on their responsibilities regarding devices for which an Humanitarian Device Exemption has been approved published August 2008. (Section 303) 
  • Draft Pediatric Device Development Plan dated June 2008 published on NIH Pediatric Medical Devices Stakeholders Workshop website. An NIH, FDA, and AHRQ Working Group has met and developed preliminary plans and process. Public Meeting held July 2008. Plan is being finalized. (Section 304) 
  • Pediatric Device Consortia Program established and Requests for Applications issued in May 2009. Grants awarded to three consortia on September 18, 2009. (Section 305) 

Title IV – Pediatric Research Equity Act (PREA) and Title V – Best Pharmaceuticals for Children Act (BPCA)

  • Pediatric Review Committee (PeRC) (internal review committee) established October 2007. 103 meetings as of August 31, 2009. 
  • During the period from October 27, 2007, through August 31, 2009, PeRC has made 573 recommendations under PREA, reviewing assessments, plans, deferrals, and waivers (includes drugs and biologics). This accounts for: 
    • 115 pediatric plans for PREA assessments 
    • 92 PREA assessments 
    • 116 deferral requests for PREA assessments 
    • 250 PREA waiver requests 
  • PeRC has made 42 recommendations under BPCA, reviewing Written Requests, amended Written Requests, and inadequate proposed pediatric study requests. This accounts for: 
    • 29 Written Requests 
    • 9 Amended Written Requests 
    • 4 Inadequate Letters 
  • Internal Processes established for expansion of safety reviews for PREA. 
  • 23 written requests for studies under BPCA have been issued; 12 are still pending. 
  • 287 PREA and BPCA Labeling changes posted on website. 
  • 83 labeling changes since FDAAA enactment. 
  • Medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued by CDER under the BPCA (24) and pediatric assessments conducted under PREA (38) have been posted on the website. The home page for pediatric drug development is found at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm
  • CBER has posted reviews of pediatric assessments for 10 products. The website is http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm
  • Breakdown of Requested Studies Report; Written Requests Issued; Pediatric Exclusivity Granted; Pediatric Exclusivity Statistics; Spectrum of Diseases/Conditions; PREA Pediatric Study Data - posted on FDA website. 
  • PeRC Retrospective Review is near completion. 
  • CDER webpage includes additional elements required to be tracked and posted. 
  • Pediatric Labeling guidance is planned. 
  • BPCA and PREA guidances are undergoing revision. 

Title VI – Reagan-Udall Foundation 

  • Foundation Established – October 2007. 
    • Board appointed – November 2007; first board meeting – January 2008. 
    • Foundation has received 501(c)(3) confirmation from the Internal Revenue Service. 
    • Foundation is fully operational; Board meetings held regularly and fundraising is underway. 
  • Chief Scientist Appointed – April 2008. (Section 602) 

Title VII – Conflicts of Interest 

  • Created templates to immediately implement provisions regarding conflicts of interest waivers and disclosure of financial information for Advisory Committee members. 
  • First annual Report to Congress on advisory committee vacancies and disclosures submitted for FY 2007 in May 2008. Second annual Report to Congress sent in May 2009. 
  • Public disclosures of financial interests and the justification for the waiver implemented immediately. Process is ongoing – all disclosures and waivers are posted on FDA’s website. FR notice announcing Final Guidance on Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers, including new templates for disclosure and waivers published on August 5, 2008. 
  • Final Guidance on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees made available August 5, 2008. This guidance replaces FDA’s 2000 Waiver Criteria guidance and incorporates a more stringent policy on considering waivers of conflict of interest as well as changes due to FDAAA. 
  • Administrative changes have been made to incorporate new requirements for all term appointments initiated after October 1, 2007; process is ongoing. 
  • Increased outreach and recruitment efforts to fill advisory committee vacancies. In FY 2008: 
    • Greater than 500 nominations received through FDA’s advisory committee website for committee vacancies. 
    • Contacted 269 professional organizations to recruit new members. 
    • Mailed/e-mailed 371 communications seeking new nominees. 
    • Attended 24 professional meetings seeking out new members. 

Title VIII – Clinical Trial Databases

  • Developed FDA Certification Form in December 2007 to implement requirement that such form be submitted with FDA applications and submissions; published draft guidance in April 2008. Final guidance published on January 21, 2009. 
  • Creation of 7 working groups with NIH to implement provisions of clinical trial registry and results database (FDA has been working with NIH, although most provisions are NIH’s responsibility). 
  • Worked with NIH to implement first phase of “linking” information (information on FDA actions linked to clinical trials registry information). December 2007. Additional IT efforts are underway to enhance linking additional information. 
  • NIH held the public meeting on expanding the registry and results database on April 20, 2009. FDA assisted with the meeting and participated. 

Title IX – Enhanced Authorities Regarding Postmarket Safety of Drugs 

FDAAA provides FDA with additional requirements, authorities, and resources with regard to both pre- and postmarket drug safety. The statute contains important new authorities to require postmarket studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies (REMS). The new safety authorities in Title IX, Subtitle A of FDAAA took effect on March 25, 2008. 

  • Between March 25, 2008 and September 14, 2009, FDA (CDER and CBER) issued 74 letters with postmarketing requirements to assess safety issues for drugs and biologics. In the past, these kinds of studies and clinical trials would have been undertaken voluntarily, as postmarketing commitments; now they are required, and the established timeframes for the conduct of the studies are enforceable. 
  • As of September 14, FDA (CDER and CBER) had used its new authorities to require safety label changes 22 times since March 25, 2008. Most of the required safety label changes were invoked for classes of drugs or biologics. For example, FDA required safety label changes to add the risk of neuroleptic malignant syndrome to the prescribing information for selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). FDA also required safety labeling changes for oral sodium phosphates to address the risk of nephropathy, and for testosterone gels to address the risk of secondary exposure to children. 
  • FDA can require REMS to ensure that the benefits of a drug outweigh its risks. As of September 14, 2009, CDER has approved 78 REMS, 59 REMS that include only a Medication Guide, and 19 that include elements other than a Medication Guide (e.g., a communication plan and/or elements to assure safe use, and also, in some cases, a Medication Guide too). Of those 19, 6 have elements to assure safe use. Two deemed REMS are also approved with elements to assure safe use, but are not counted in the 6 new REMS with elements to assure safe use because these drugs had risk management plans in place with elements to assure safe use before FDAAA. During that time, CDER and CBER approved over 275 new applications and efficacy supplements. 
  • In May 2008, FDA launched the Sentinel Initiative. The Sentinel Initiative is a long-term FDA effort to create a national electronic system for monitoring product safety. The Sentinel System, once up and running, is intended to augment FDA’s existing postmarket (primarily passive) safety surveillance systems and to enable FDA to actively gather information about the postmarket safety and performance of its regulated products. The Sentinel System will enable queries of automated healthcare data systems (e.g., electronic health record systems, administrative claims databases, registries) quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be used. The Sentinel System is expected to work as follows: Questions would be sent to appropriate, participating data sources, who in turn would, in accordance with existing privacy and security safeguards, evaluate their data and send results summaries to FDA for review. This system will satisfy the requirements of section 905, which directed FDA to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires FDA to work closely with partners from public, academic, and private entities. 
    • FDA has created a broad forum to gather public input on issues related to creation and development of Sentinel; numerous meetings have been held. 
    • On December 16, 2008, a public workshop, co-sponsored by the eHealth Initiative Foundation and the FDA, and convened in cooperation with the Brookings Institution, was held. 
    • FDA has established a Federal Partners Working Group to share information and discuss issues related to ongoing efforts being carried out by Federal agencies that are complementary to Sentinel. This working group consists of representatives from the Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, Office of the National Coordinator, Office for Human Rights Protection, Substance Abuse and Mental Health Services Administration, Indian Health Service, Health Resources and Services Administration, Consumer Product Safety Commission, Department of Defense, National Institutes of Health, Agency for Healthcare Research and Quality, and the Department of Veterans Affairs. 
    • Work under 7 of 8 contracts awarded in 2008 to provide foundational information needed to inform the development of the Sentinel System has been completed. All completed reports are available via the Sentinel Initiative Website, where FDA has opened a docket and piloted a Discussion function to facilitate public comment on submitted contract work. 
  • Multiple activities are under way that will provide information for development of the Sentinel System. Among the activities are the following: 
    • FDA is in the process of seeking an organization within the private sector to function as a Coordinating Center to lead a consortium of automated healthcare databases and that would have the staffing and expertise to work with FDA to develop and implement the specific scientific operations that would be needed for a small-scale (or “mini”) Sentinel System. This Mini-Sentinel’s Coordinating Center would be able to access automated healthcare data from consortium members in response to specific FDA queries. The Mini-Sentinel pilot will provide a “laboratory” giving FDA the opportunity to evaluate safety issues and learn more about some of the barriers and challenges, both internal and external, to establishing a Sentinel System. Contract award is expected in-September. 
    • OMOP (Observational Medical Outcomes Partnership with FNIH, FDA, PhRMA). Under a partnership involving FDA, the Foundation of the National Institutes of Health, and the Pharmaceutical Manufacturers of America, a series of experiments are being conducted to assess the value, feasibility, and utility of observational data to identify and evaluate the safety risks and potential benefits of prescription drugs. 
    • FDA-CMS-ASPE Safe Rx Program (using Medicare data). FDA and the Centers for Medicare & Medicaid Services (CMS), with the assistance of the Assistant Secretary for Planning and Evaluation (ASPE), have launched a project that is using Medicare data to better understand post-market safety of FDA regulated products. Projects have been launched in all three medical product centers. 
  • Interagency agreements have been put in place between FDA, CMS, the Department of Defense, and the Department of Veterans Affairs to further develop the science of medical product surveillance. This effort will focus on developing signal strengthening methodologies. This “distributed network” pilot (Mini-Sentinel II) could mirror what FDA envisions doing on a larger scale with the Sentinel System. 
    • FDA has awarded a cooperative agreement that will facilitate discussion on topics related to developing and creating active medical product surveillance methods and systems. This group will convene a broad range of stakeholders, to include those with relevant expertise, to explore and address methodological, data development, technical, and communication issues related to active medical product surveillance. Contract award is expected in September. 
    • FDA has awarded a contract to conduct a legal evaluation of state statutes, regulations, and practices in each of the 50 states. It is noted that Federal regulations, including the HIPAA Privacy Rule, constitutes a minimum for privacy protection, so states can enact more rigorous privacy protection if desired. FDA is seeking to determine whether those state laws impose any additional restrictions on the use or disclosure of health information beyond the Federal law requirements discussed in the legal analysis already received by the Agency. 
    • FDA has awarded a contract to identify, describe, and evaluate potential data sources and/or data environments that could participate in the Sentinel Initiative to assist in the understanding of drug safety issues as they manifest in animals. 
  • Direct to Consumer (DTC) advertisements 
    • FDAAA requires that we issue regulations on the standards for determining whether advertisements are clear, conspicuous, and neutral as it relates to side effects and contraindications. On August 6, 2008, we published a FR notice on Agency Information Collection Activities for a study on distraction during the risk presentation in broadcast ads that will provide data relevant to establishing the “neutral” standard; a final notice on Agency Information Collection Activities for the study was published in the FR on December 30, 2008. This information collection request was approved by OMB on May 27, 2009. 
    • FDAAA requires that FDA, in consultation with the Advisory Committee on Risk Communication, report to Congress on the ability of DTC ads to communicate to subsets of the general population. On April 28, 2008, we published a FR notice to obtain comments on issues related to the report on Direct-to-Consumer Advertising including how DTC advertising relates to communicating to subsets of the general population, and increased access to health information and decreased health disparities for these populations. On May 15, 2008, we met with the Advisory Committee to obtain their input on these topics. On January 13, 2009, we published a FR notice and request for comments seeking information to determine whether there are specific impediments to participation of certain groups in clinical trials to address the second issue required to be included in the Report to Congress. The Report to Congress is expected to be transmitted in late September. (Section 901) 
    • FDAAA requires FDA to conduct a study in consultation with the Advisory Committee on Risk Communication, on the appropriateness of including, in televised DTC ads, a statement encouraging consumers to report negative side effects of prescription drugs to MedWatch (as is currently required for print DTC prescription drug ads). FDA has to report the findings of this and any plans to issue regulations to require the statement in TV ads to Congress. FDA met with the Advisory Committee on May 16, 2008, to obtain input on the proposed design of the study, and delivered an interim report to Congress on May 12, 2008. FDA published a FR notice soliciting public comments on this proposed study design on November 26, 2008; comments were due by January 26, 2009 and have been analyzed. FDA published the second FR notice on the toll free study requirement on August 18, 2009, and the comment period closed September 19, 2009. (Section 906) 
  • Issued three draft guidances on conducting clinical trials involving antimicrobials to treat acute bacterial sinusitis, antimicrobials to treat acute bacterial otitis media and acute bacterial exacerbations of chronic bronchitis in patients with Chronic Obstructive Pulmonary Disease. (October 30, 2007, January 18, 2008, August 21, 2008). (Section 911)
  • Prohibit the introduction into interstate commerce any food to which has been added certain drugs or biological products, unless the drug or biological product meets certain requirements. FR Notice published on July 29, 2008; requests for comments extended until November 25, 2008. Completing analysis of the comments to the FR notice. (Section 912) 
  • Published two requests for information in the FR on March 20, 2008, to support the development of standards for identification, validation, authentication, and tracking and tracing of prescription drugs. Published a draft guidance on recommendations for standardized numerical identification of prescription drug packages on January 16, 2009. Comments received on the draft guidance have been reviewed and work on the final guidance has been initiated. (Section 913) 
  • As of September 15, 2009, we had responded to 38 Citizen Petitions subject to new section 505(q) of the Act. Thirty-six of those petition responses were completed within the statutory deadline of 180 days or less. (Section 914) 
  • Issued draft guidance Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act on January 21, 2009. Comments received are under review. (Section 914) 
  • Report to Congress entitled, Encouraging Early Submission of Citizen Petitions and Petitions for Stay of Agency Action was sent to Congress on April 2, 2009. First Annual Report to Congress entitled Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2008 was sent to Congress on April 28, 2009. (Section 914) 
  • Launched public website October 15, 2008, to list approved REMS and other safety information. The website is at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm. (Section 915) 
  • The process for posting action packages in a timely manner has been established and many action packages have been posted. (Section 916) 
  • Risk Communication Advisory Committee established: Six meetings held since inception. (Section 917) 
  • Section 919 of FDAAA requires FDA to conduct an assessment of how the FDA has implemented the recommendations described in the IOM report and the requirement under section 505-1(c)(2) of the Act (added by FDAAA) regarding working relationships between the offices responsible for reviewing and approving drugs and the offices responsible for monitoring postapproval safety. The report, Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System, was submitted to Congress on August 20, 2009. As required by FDAAA, the report describes that FDA has used a team-based approach to making decisions about the need for and content of REMS. In CDER, team representatives from the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE) work together in each case to determine the appropriate exercise of the new authorities. In addition, numerous other activities are under way to enhance the working relationships between these offices. Similarly, CBER has created cross-disciplinary teams who work collaboratively on implementing the FDAAA safety provisions. CDER and CBER are working together to ensure consistent implementation of FDAAA. (Section 919)
  • Published final rule on July 28, 2009, implementing requirement for NDA holders to provide Authorized Generics information to FDA in annual reports. Published timely quarterly updates to FDA Listing of Authorized Generics (most recently, July 20, 2009). (Section 920)
  • Listing of drugs and biologics from Adverse Event Reporting System (AERS) for which FDA is investigating a potential safety signal was first posted on the AERS website in September 2008 and has been updated three times. The lists consist of the product name, the safety issue and links to additional public information. To date, data from all four quarters of 2008 have been posted. This data can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm. (Section 921) 
  • FDA/CDER continues to work with a contractor to review and streamline the backlog of postmarketing requirements and commitments (PMRs/PMCs). FDA contracted with Booz Allen Hamilton to conduct a review of the backlog. The contractor’s final report on the backlog review was posted on the FDA web site on September 3, 2009, accompanied by a press release and media conference call. The FY2008 annual FR notice on the progress of PMRs/PMCs was also published September 3, 2009 and reflected the results of the backlog review as of September 30, 2008. Review of the backlog of PMRs/PMCs for FY2008 is complete and the FY2009 review is underway. A Report to Congress on the status of the backlog review is being drafted. (Section 921)
  • FDA/CBER has conducted its own backlog review of 83 open postmarketing commitments. A comparison between the statuses on September 27, 2007, and the statuses as of June 12, 2009 confirmed that most PMRs/PMCs had been consistently and appropriately updated from ongoing to submitted. CBER has begun its planned follow-up to obtain complete schedules for the backlog PMCs with missing completion dates.

Title X – Food Safety 

Title XI – Other Provisions

  • FDA issued a draft guidance, Tropical Disease Priority Review Vouchers, on October 9, 2008, to support implementation. Comments were received and we are currently drafting a Final Guidance. FDA held a Part 15 Meeting: Designating Additions to the Current List of Tropical Diseases, on December 12, 2008, to obtain public input on important diseases that should be added. Because of the problematic offsetting provisions relating to the priority review user fee, FDA has not yet established a priority review user fee. (Section 1102)
  • FR Notice of Availability of Draft Guidance, Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices, published on June 12, 2008 and the Final Guidance was published June 29, 2009. The Final Guidance describes how FDA intends to comply with the FDAAA requirement to identify and periodically update clinically susceptible concentrations (values that describe the susceptibility of bacteria to specific antibacterial drug products) and make that information publicly available. (Section 1111)
  • April 28, 2008, FDA held a Public Hearing re: serious and life-threatening diseases due to antimicrobial resistance. (Section 1112)