Congress Hugs It Out On FDA Reform
Posted by Jacob Goldstein
Congress has been wrestling for months over a bill that would give the FDA more power over drugs once they hit the market. Now it looks like the two legislative chambers are finally hugging it out — the House just passed a compromise bill (405-7), and it’s expected to clear the Senate and to be signed by the President in short order, according to Dow Jones.
Read the fruit of Congress’ labors here, or a summary here.
If the bill becomes law, the FDA will have all sorts of new powers, including ordering companies to study drugs already on the market and to change their instructions for use, or labels. FDA will have the authority to compel companies to do better tracking of potential safety problems associated with drugs when they first hit the market after approval. Also, drug companies will have to register all clinical trials in a database run by the National Institutes of Health.
Part of the delay in reaching a compromise stemmed from a debate over protection of drug companies from liability. The Bush administration and its allies have been staunch supporters of the power of an FDA-approved label to trump state law, shielding companies from some liability claims. The House bill could curtail that protection by saying that drug makers have a duty to keep their drugs’ labels up to date, regardless of the FDA.
The bill renews the program, quaintly called PDUFA, that charges the pharmaceutical companies to review their applications for new drugs. The agency stands to collect $392.8 million for fiscal year 2008, up $87.4 million over the current base, according to the summary.
Congress is taking this one down to the wire. The current version of PDUFA is set to expire at the end of the month, and the agency said it would have to start sending out pink slips to as many as 2,000 FDA employees if Congress couldn’t agree on new legislation by September 21, Dow Jones reports. [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-08-29 17:12