Congress's FDA Bill Includes Reforms

The House and Senate have both passed legislation that renews the FDAâs user-fee system and enacts some important reforms. The process has been rushed because FDA is running dangerously low on funds; President Bush will need to sign the legislation today if the FDA is to avoid sending termination letters to one-fourth of its staff.

First, some background: In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA) and set up a system in which drug companies pay annual fees and fees for each prescription drug product they market, and these fees help fund the FDA's process of reviewing new drug applications. PDUFA has to be reauthorized every five years, and advocates of drug safety and scientific integrity â including my colleagues at the Project on Scientific Knowledge and Public Policy â used the 2007 reauthorization process to push for reforms. (Go here or here for more details.) Under the current user-fee system, the FDA has devoted more resources to reviewing new drug applications and meeting new goals for review times, but its post-approval drug safety activities have suffered and some of its reviews have been rushed. Vioxx and other drugs that FDA has approved have turned out to have serious side effects and have been pulled from the market, and a 2006 Institute of Medicine report concluded that the agency needed significant reforms to improve drug safety.

Here are the important steps that the bill takes:

⢠Better post-market monitoring â Instead of relying on doctors and drug companies to report side effects, the FDA will be able to access large patient databases (like those kept by Medicare, the Veteransâ Administration, and private insurers) and require companies to closely monitor newly released drugs.

⢠More FDA authority over labeling â The FDA will have more power to require changes to drug labels and prescribing literature when problems do become apparent after a drugâs approval.

⢠Clinical trials reporting â Companies will have to post results from clinical drug trials involving approved medicines.

⢠Conflict of interest and advisory committees â The FDA wonât be able to issue as many waivers to members of FDA advisory committees who have conflicts of interest. Some advocates had argued for an elimination of the waivers altogether, but the current bill is a step in the right direction. FDA will also get more resources to devote to tracking post-approval drug safety.

Also, in something that is not so much stepping forward as avoiding a step backward, the bill doesnât include a pre-emption provision, which would give drug companies immunity against product-liability claims if the FDA had approved their products. (See Pharmalot for more on this particular provision, or this post for more on why pre-emption is problematic.)

The biggest area where drug-safety advocates didnât come close to getting what they wanted was direct-to-consumer advertising (some have called for a complete ban on DTC). FDA will get to review ads before they air, but thatâs about it.

GoozNews, Terra Sigillata, and Angry Toxicologist have their reactions to the legislation, and the LA Times and Baltimore Sun have published articles about it.