June 2012

User Fee Reauthorization Update

On June 18, ranking members of the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee announced that they had reached an agreement on the Food and Drug Administration Safety and Innovation Act (S. 3187). The bill would raise, by more than $2 billion from the previous five-year period, the fees that Food and Drug Administration (FDA) collects in exchange for the review of medical therapies including new sets of fees generated by the establishment of generic drugs and biosimilar review mechanisms.

The agreement, which was added as an amendment to the Senate bill after being agreed to by a voice vote in the House, contains elements from both bills including an extra five years of market exclusivity for qualifying new antibiotics, a requirement that FDA propose regulation for a unique device identifier program by the end of the 2012 and a requirement for a multi-agency and stakeholder collaboration to recommend a regulatory framework for mobile applications and other types of health IT software. Removed from the final version of the legislation where previous attempts to create a track and trace system for drug shipments.

The Chairman of ACT-AD submitted a letter to the chairmen and ranking members of the authorizing committees during their conference on the House and Senate bills. The letter supported a number of enhancements that were ultimately included in the final bill. The letter specifically cited accelerating drug development through greater focus on regulatory science; supporting the development of innovative clinical trial designs; re-evaluating how the FDA assesses benefits and risks of therapies and communicates benefit-risk information; and ensuring that Risk Evaluation and Mitigation Strategies (REMS) do not serve as a barrier to patients in need of treatments, among other important components.

After an easy passage in both chambers, the bill is on schedule to reach President Obama’s desk by the July 4 congressional recess.

To view the reconciled bill, click here.

To view ACT-AD’s letter of support, click here.

FDA Appropriations Update

Under proposed legislation (H.R. 5973) adopted by the House Appropriations Committee on June 19, the Food and Drug Administration’s (FDA) appropriated funding would see a $16 million, or .7%, decrease from its FY 12 level of $2.497 billion for salaries and expenses. In addition, the Committee chose not to fund monies that support building and facilities repair. The cuts, while steep, are commendable when compared to the President’s original budget proposal for FY 13 that called for a 1% cut in appropriations for the agency’s drug and device divisions.

Also included in the reconciled bill, was an amendment introduced by Rep. Rosa DeLauro (D-CT) that requires funding for the Reagan-Udall Foundation to come from the Office of the Commissioner. The foundation is a non-profit, created by Congress, to advance regulatory science related to the U.S. Food and Drug Administration.

The funding measure was contained within a larger, and easily approved, FY 13 appropriations bill covering spending proposal for the United States Department of Agriculture (USDA), the FDA, and their respective oversight of food safety, animal and plant health, rural development and farm services, and nutrition programs. The bill estimates nearly $141 billion would be needed for mandatory spending next year and provides $19.4 billion for discretionary programs between the two agencies.

Ahead of the House’s expect end-of-June vote, the Administration’s Office of Management and Budget (OMB) issued an official veto threat, citing the bills conflict with the bi-partisan 2011 Budget Control Act, and it’s potentially catastrophic effect on FDA’s critical mission of ensuring the safety of food and medical products. OMB urged the continuation of the rigorous implementation of the Food Safety Modernization Act, and the improvement of oversight for imports, and the investment in the development of medical products.

While the Senate’s $24 million increase, which passed in April, is far better than the House’s $16.3 million cut, both still fall far short of the $150 million increase called for by FDA advocates.

To view the bill, click here.

To view OMB’s letter, click here.

NAPA to Hold Advisory Council Meeting Next Month

The Advisory Council on Alzheimer’s Research, Care, and Services, tasked with guiding the National Alzheimer’s Project Act, is scheduled to hold its fifth meeting on July 23 in Washington, DC. The meeting is slated to include reports from a number of federal officials leading the implementation of the recently released, final version, National Plan to Address Alzheimer’s Disease. Their reports will address current progress of the Plan, and an explanation of how its implementation will be tracked.

The Advisory Council’s last meeting was April 17, during which, a representative from the Department of Health and Human Services (HHS) presented an overview of the National Plan to Address Alzheimer’s Disease in its draft form. The Advisory Council then discussed, and voted upon, recommendations to send the Secretary of HHS. Following the meeting, the Advisory Council held an open public session to address issues that stakeholders believed should be included in the National Plan.

To view the final Plan, click here.

For more details on the Advisory Council’s April meeting, click here.

Winner of Alzheimer’s Challenge 2012 Announced

The Alzheimer’s Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy and Pfizer Inc., together with the Geoffrey Beene Gives Back® Alzheimer’s Initiative have selected the winner of their Alzheimer’s Challenge 2012. Ginger.io, and their winning Behavioral Analytics Platform, was announced during an event held in Washington, D.C. on June 19, and was awarded $175,000 to help usher their work toward commercialization.

Their platform is a combination of a mobile phone application and web-based dashboard. The platform passively tracks Alzheimer’s patients’ behavior relevant to their mood, memory and functional status, and administers standard Alzheimer’s cognitive assessments to provide health care providers with a dashboard to measure patient health status, easy-to-interpret scores and novel data analytics to follow new treatments and improve patient care.

Five finalists were selected from over 100 submissions and had to present a prototype of their idea to a panel of judges during the June 19. Team Ginger.io’s submissions was credited as best supporting the Challenge objective of developing a simple, cost-effective, consistent tool that can be easily used to assess memory, mood, thinking and activity level over time to help improve diagnosis and monitoring of people with Alzheimer’s disease.

Visit www.alzheimerschallenge2012.com for more information, including Official Rules.