June 2011

House Approves Funding Cuts to FDA

The House of Representatives voted to approve the Agriculture Appropriations Bill for Fiscal Year 2012 on June 16 with a vote of 217 to 203.  The final version of the bill includes a $285 million cut in the Food and Drug Administration’s (FDA) funding from FY 2011 levels.

While the FDA did fair better than other federal agencies in the bill, the total funding cut still amounts to a decrease of 11.5% below last year’s budget authority level, bringing the total funding for the FDA, including user fees, to $3.7 billion.  Given that the agency has been severely underfunded for decades and plays a central role in ensuring that new tools and treatments for diseases like Alzheimer’s are made available to people who need them, cuts of this level are unacceptable.

Advocates are actively seeking a higher number for the FDA, as Senate prepares to act on funding issues for FY 2012. ACT-AD members are encouraged to weigh in with members of the Senate Agriculture Appropriations Subcommittee to support funding for the FDA in FY 2012 that is commensurate with the challenges it faces in protecting and promoting the health of all Americans, including those with Alzheimer’s disease.

To view a list of Senate Agriculture Appropriations Subcommittee Members, click here.

To view the House Agriculture Appropriations bill as reported to the Senate, click here.

FDA, Industry, agree on PDUFA V

After ten months of negotiations, the FDA, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhARMA) have reached agreement on the terms for renewing the prescription drug user fee program, The Prescription Drug User Fee Act (PDUFA).  authorized the FDA to collect fees for the review of new human drugs and biological products.  This is the fifth reauthorization since its enactment in 1992, The recently published agreement will increase fees $100 million over five years and adds an additional two months of review time for new drug applications, with the goal of completing a higher percentage of reviews on schedule.

In addition to an increased percentage of timely approvals, the agreement includes elements that are highly relavant for ACT-AD that  improve FDA’s communication withboth industry and patients.  Under PDUFA V there would be more meetings and interaction between the FDA and industry, as well as formal procedures for integrating patient perspectives into review criteria. The FDA, has also laid out specific plans to utilize advice received from patients to change the way it assesses benefits and risks, as well as the endpoints it uses to assess the safety and efficacy of new drugs. The increase in patient input is being hailed as a means by which to mitigate politically induced risk aversion in the agency’s review of developing therapies.

PDUFA V agreement also includes funding to help promote and improve regulatory sciences.  The FDA has agreed to fund 119 full-time employees dedicated to working on the agency’s regulatory process, and committed to the integration of new sciences and patient perspectives into its drug and biologics reviews.  The FDA will also have funding for an initiative that aims to increase the quality and integration of meta-analyses and for additional regulatory science staff to be dedicated to reviewing biomarkers and pharmacogenomics data.

The agreement has now been sent to Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) for review, and the FDA will be releasing another draft of the agreement before the a public meeting in October.  The agreement will then be passed on Congress where it will be rolled into enacting legislation for passage before PDUFA IV expires in September of 2012

To view minutes from all the meetings held during negotiations click here.

Congressional briefing to be held on Alzheimer’s and the next generation of innovations and therapies

On July 14th, the California Healthcare Institute(CHI) and the Healthcare Institute of New Jersey(HINJ), will be hosting an informational briefing on the importance of therapeutic advancements and innovations in Alzheimer’s disease.

The briefing aims at increasing awareness of the imminent increase in dementia caused by Alzheimer’s disease and other conditions.  There will be a focus on increasing support for the development of new innovations and treatments which, remain all the more critical to assist in improving the quality of life for Alzheimer’s patients. The program will include an overview of advances stemming from California and New Jersey’s life science sectors, and an expert panel to discuss current research and drug development, as well as future discoveries.

The briefing will be held in the Capitol Visitor’s Center – Congressional Meeting Room South, from 9:30am to 11:30am.  Scheduled to be in attendance are Rep. Chris Smith (R-NJ) and Rep. Linda Sanchez (D-CA), as well as a number of notable thought leaders.