Date: December 9th, 2015
This year marked many important policy issues that were of interest to the Alliance. For this edition of Get Mad before You Get Old, we highlight some of the ongoing issues of interest.
Reauthorization of the Prescription Drug User Fee Act (PDUFA) program
The Prescription Drug User Fee Act, or PDUFA, passed in 1992, authorized the U.S. Food and Drug Administration to begin collecting fees from drug sponsors to give it more resources to review new drugs more quickly. Since then it has gone through four reauthorizations, with its fifth due in 2017. The Alliance has been very active in the review process, appearing in numerous meetings and offering insights and suggestions from the stakeholder perspective on PDUFA V. You can read more here.
Reauthorization of the Medical Device User Fee Act (MDUFA)
Another area of interest is the Medical Device User Fee Act, which was passed in 2002 to enable FDA to collect user fees from medical device sponsors for review activities. It is due for its fourth reauthorization in 2017. As with PDUFA, the Alliance has been active in participating in the review process. You can read more about our involvement here.
The threat of antibiotic resistance continues to be an alarming trend on a global scale. Our President and CEO Susan Peschin, MHS, noted in a blog post recently that threats such as healthcare-associated infections (HAIs) need to be checked in the near term. The Alliance has been active throughout the year on this issue, including joining the White House’s Forum on Antibiotic Stewardship. We also held a forum about HAIs. We will continue to advocate for more focus on antibiotic resistance in the coming year.
21st Century Cures
The Alliance has been following the progress of this bill all year. The 21st Century Cures Act will bring the U.S. “health care innovation infrastructure into the 21st Century, delivering hope for patients and loved ones and providing necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments.” Earlier this year, it passed in the U.S. House of Representatives. We issued this statement on its passage, “The Alliance for Aging Research applauds the U.S. House of Representatives on today’s passage of H.R. 6, the 21st Century Cures Act. This bill makes vital changes to how biomedical research will be conducted in this country and removes barriers to therapeutic development that will ensure patient access to innovative treatments and life-saving cures. The Alliance would like to extend a special thanks to Chairman Fred Upton and Representative Diana DeGette for their bipartisan leadership and dedication to crafting H.R. 6 in the interest of patients. We look forward to the Senate taking action on this important bill and the innovations that will be realized in the years to come as a result.” To date, legislation is still pending in the Senate.
Funding for the National Institutes of Health
After years of stagnant funding, the National Institutes of Health has been given an increase of $2 billion for FY16, while the National Institute on Aging received a $350 million bump. The Alliance was pleased with this proposed increase. However, the final federal budget has not yet been approved by Congress, so we are watching closely to see what happens on Capitol Hill.