U.S. PIRG Consumer Blog: FDA proposes more drug safety

Yesterday, the Food and Drug Administration (FDA) proposed modest improvements to its drug safety efforts. Response from Congressional critics was swift: not good enough. We expect to work with Congressional champions of FDA reform, including Rep. Henry Waxman (D-CA), and Senators Enzi (R-WY), Grassley (R-IA), Dodd (D-CT) and Kennedy (D-MA) and others on a variety of legislative efforts to improve both the funding and independence of the FDA's post-market safety efforts and the transparency of clinical drug testing.

Over the last fifteen years, under pressure from powerful drug manufacturers, the mission of the FDA has been distorted by an increase in user-fee funding that could largely only be used to approve new drugs, without concomitant increases in funding for critical post-market safety reviews. This created an over-emphasis on approving these new drugs at the expense of programs guaranteeing the safety of drugs already on the market. As we pointed out in 2005 comments to the Institute of Medicine:

Since the passage of the Prescription Drug User Fee Act (PDUFA), funding for most of the FDA's critical drug research functions-with the exception of new drug approval-has declined. In the past 11 years, spending on new drug reviews increased from 53 percent to more than 79 percent of the agency's drug center budget.

As the New York Times story F.D.A. Widens Safety Reviews on New Drugs notes today, the expiration of the PDUFA funding has forced the once-omnipotent drug lobby PhRMA to the Congressional table:

The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs. That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.

The urgency of the renewal of the PDUFA user fee program provides an outstanding opportunity for Congress to conduct broad oversight of the FDA and to do a lot more than simply reforming the fee mechanism so some of the money goes to post-market safety. More on PIRG's Safe and Affordable Drugs campaign work here.