April 2012

FDA FY 2013 Appropriations Update

On April 19, as she testified before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, FDA Commissioner Margaret Hamburg highlighted the uncertainty surrounding the agency’s FY 2013 funding and capacity. Hamburg pointed out that although the agency’s initial budget proposal of $4.5 billion is a 17% increase over FY 2012 levels, 98% of that increase is hinges upon a pending increase in fees for the review of prescription drugs, medical devices and a number of other consumer products. During the hearing the commissioner and a number of senators, warned of a funding imbalance by maintaining that the agency’s primary source of support for carrying out its mission of protecting the public health should be appropriations from public dollars, and user fees should only be a means by which the FDA can more effectively execute specifically designated activities under that mission.

The Senate Appropriations Committee held a full committee mark up of its FY 2013 bill. Under the proposed legislation adopted by the committee, FDA’s appropriated funding would be increased by $24 million above its FY 2012 level of $2.507 billion. The House Appropriations Committee has not yet announced a schedule for its action on FY2013 appropriations for the agency.

To view Commissioner Hamburg’s testimony, click here.

To view a summary of the Senate FY 2013 Agriculture and FDA Appropriations Bill, click here.

User Fee Reauthorization Update

Congressional activity on the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V) is intensifying. Multiple hearings have been held by the House and Senate committees of jurisdiction with both aiming to mark up their respective bill to reauthorize the programs by May and complete consideration before the August recess.

During a House Energy and Commerce Subcommittee on Health hearing on April 16, the directors of the Food and Drug Administration (FDA) centers for drug and device evaluation testified on the draft of the user fee agreements which would fund almost a quarter of the agency’s activities in FY 2013. The House Energy and Commerce Committee subsequently released its draft legislation which reauthorizes the user fee agreements for drugs, devices, generics and biosimilars. It also contains changes to the FDA’s policies related to conflicts of interest, reforms to certain medical device monitoring processes, as well as measure to address supply chain safety, drug shortages, antibiotic incentives, and expansions of accelerated approval pathways.

After releasing several discussion drafts for public comments, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released its draft bill, the “Food and Drug Administration Safety and Innovation Act.” Like the House bill it reauthorizes the user fee agreements for drugs, devices, generics and biosimilars. It also contains the committee’s own proposals for addressing conflicts of interest, creating and expanding accelerated approval pathways, incentivizing antibiotic development, and ensuring supply chain integrity. The draft was markedup and approved by the full committee on April 24. The House is planning a mark up in early May.

In response to a call for comments from the Senate HELP Committee on its ”Drug Development and Patient Access Discussion Draft”, the ACT-AD Coalition Chair, the Alliance for Aging Research, submitted a statement on April 11th in support of a number of critical enhancements in the user fee agreement and draft legislation including the acceleration of drug development through better regulatory science, supporting the development of innovative clinical trial designs, and the re-evaluation of the FDA’s risk benefit assessment framework.

To view the House draft, click here.

To view the Senate draft, click here.

To view the Alliance for Aging Research’s comment letter on the Senate draft, click here.

NAPA Advisory Council on Alzheimer’s Research, Care and Services, Releases Revised Draft National Plan to Address Alzheimer’s Disease

On April 13, the U.S. Department of Health and Human Services released its second draft of the National Plan to Address Alzheimer’s Disease (AD). The release came just before the April 17 public meeting of the Advisory Council on Alzheimer’s Research, Care and Services. This version of the plan includes five major “building blocks” for achieving its vision of eliminating AD:

  • Prevent and effectively treat AD by 2025
  • Optimize care quality and efficiency
  • Expand supports for AD sufferers and their families
  • Enhance public awareness
  • Track progress and drive improvement.

For these five goals, the plan highlights strategies for immediate action. Included in those strategies are the identification of research priorities and milestones; expansion of research aimed at preventing and treating AD; the acceleration of efforts to identify early stages of AD; and the facilitation of translating findings into medical practice and public health programs.

The official period for public comment has closed, but comments can still be sent to [email protected]. The final national plan is expected to be released between May 10 – 14.

To view the second draft of the National Plan to Address Alzheimer’s Disease, click here.

For more information on NAPA and its Advisory Board, click here.

REMINDER: HHS and NIA to Hold Alzheimer’s Disease Research Summit

This May, the Department of Health and Human Services (HHS) and the National Institute on Aging (NIA) will be hosting Alzheimer’s Disease Research Summit 2012: Path to Treatment and Prevention, with support from the Foundation for NIH. The Summit has been identified by HHS and the Chair of the National Advisory Council for the National Alzheimer’s Project Act (NAPA) as a key objective to identify research strategies and priorities to prevent and treat Alzheimer’s disease (AD).

The Summit will take place on Monday, May 14 from 8 AM to 6 PM, and Tuesday, May 15 from 8 AM to Noon. It will be located in the Natcher Auditorium of Building 45 at the National Institutes of Health in Bethesda, MD.

The ACT-AD Coalition is a sponsor of the event and encourages all ACT-AD members to attend.

For more information on the Summit and to register, click here.