This week, the Senate is considering the renewal of a prescription drug fee law that generates the vast majority of the Food and Drug Administration’s (FDA) budget for reviewing new medications. The FDA Safety and Innovation Act of 2012 (S. 3187) also includes a number of important provisions that will address the generic drug shortage crisis in the U.S.
For the first time, pending legislation establishes a generic drug user fee which will collect fees from generic drug manufacturers to assist in the review and approval of generic drugs. The legislation would provide the FDA with $1.5 billion in user fees from generic manufacturers over five years and reduce the average time for reviewing generic drug applications from 30 months to 10 months. This money would also help the agency hire 800 to 1,000 new employees to help expedite generic drug approvals and reach parity in inspections of domestic and international manufacturing facilities.
At the same time, the legislation also incorporates many of the key FDA notification provisions we have been advocating for. Manufacturers will now be required to give the FDA 6 months notice if they plan to discontinue or interrupt the production of a drug that could lead to a supply disruption. The bill also sets up an internal FDA task force that will be charged with identifying gaps and solving shortages.
The Lance Armstrong Foundation endorsed S. 3187 and we sent letters of support to Senate leadership. The generic drug shortage problem is extremely complex and while this legislation is no silver bullet, it will go a long way to help alleviate these shortages. This legislation has achieved bipartisan support and is supported by industry and patient groups. A final vote is expected in the Senate by the end of the week. It is anticipated that the House of Representatives will consider their companion bill after Memorial Day.
We will continue to monitor the final legislation as its way makes it through the House and Senate and keep you posted.