It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing?
Background: FDASIA's User Fee Provisions
FDASIA, passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms.
To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), both of which are structured to allow FDA to charge industry fees to submit drug and device applications in return for agreeing to meet performance goals for reviewing the applications. While both PDUFA and MDUFA contained higher fees relative to their prior authorizations, MDUFA's fees were considerably higher, and legislators may well be most interested in seeing what added industry money has done to improve regulatory performance at FDA.
FDASIA also created two new user fee programs: The Biosimilar User Fee Act (BsUFA) and the Generic Drug User Fee Act (GDUFA). The former-a comparatively small program given that no biosimilar has yet been approved in the US-is structured much in the same way as PDUFA. The latter program is much broader in scale, and is intended to eliminate a massive backlog of generic drug applications at the agency and to allow FDA to have the resources necessary to inspect generic drug production facilities abroad.
Background: FDASIA Reforms
To the latter grouping of FDASIA-its reforms contained within Titles V-X-the law contains a huge number of changes intended to solve a bevy of challenges. For example, Title X contains new provisions intended to help alleviate drug shortages, a major topic within the regulatory community that has received ample attention from legislators.
Another section, Title IX, contained provisions to create a new "Breakthrough Product Designation," which recently saw its first approval. Title VIII contained a section known as the Generating Antibiotic Incentives Now (GAIN) Act, intended to give new incentives to promote the development of antibiotics.
Section V, VI and VII respectively contain reforms to pediatric testing incentives, medical device regulations and the drug supply chain.
The Hearing: What to Expect?
On 15 November 2013, the House Energy and Commerce Committee is set to hear from and ask questions of FDA in a hearing entitled, "Reviewing FDA's Implementation of FDASIA."
According to a hearing notice posted earlier this week, hearing participants from FDA will include Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), and Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH).
The meeting had originally been planned for 3 October 2013, but was postponed as a result of the government shutdown during that same month. According to legislators, the hearing will focus on FDA's progress in implementing the provisions and vision of the FDASIA legislation.
If prior hearings are any indication, expect at least some tension during the hearing. Shuren, in particular, received a chilly reception during the FDASIA authorization hearings as some legislators accused CDRH of being too slow to approve medical devices. Woodcock, meanwhile, could receive some tough questions on whether FDA has done enough to curb drug shortages or has moved fast enough to implement certain provisions.
Similarly, it will be worth watching to see how-or if-FDA presses legislators to hold up their end of the legislative bargain. While FDASIA asked regulators to do more, legislators have thus far refused to release sequestered user fees to FDA, robbing the agency of tens of millions of dollars. The agency has also seen its general budget cut as well, robbing it of hundreds of millions of dollars which it anticipated being able to use to help train staff, increase its regulatory capacity and travel.