April 26, 2001Congressional aides have begun preparing for reauthorization of the 1997 FDA Modernization Act, the most sweeping legislation the agency has ever had to deal with.
The modernization act, which began as an effort to revise a 1992 law on FDA fees and became a large-scale overhaul reaching into every FDA department, is scheduled for renewal beginning this year.
Observers suggest that the politics surrounding the FDA and the forthcoming reauthorization could be--well, interesting, given the Bush administration's ties to the pharmaceutical industry.
"I wouldn't be surprised in this shining light of bipartisanship that it would get a lot more attention than it might have in the past," said one Democratic House aide.
The first provision to be reviewed is one based on legislation by Sens. Christopher Dodd, D-Conn., and Mike DeWine, R-Ohio. It would entice companies to improve research on the effects of drugs on children by offering six months' marketing time free from competition.
A January FDA report said that while the provision has worked well--resulting in 58 studies completed and exclusivity granted to 25 drugs in the past three years, with hundreds more in the pipeline--it could be better.
Dodd will focus on finding a way to encourage studies on drugs that are already off-patent and for which there is no monetary incentive.
Although most of the modernization act will not be up for review until 2002, some Democrats hope to bring up drug advertising, post-drug approval study commitments and expansion of review fees during the pediatric provision hearings expected later this year.
House Energy and Commerce Health Subcommittee ranking member Sherrod Brown, D-Ohio, said recently that Democrats also are contemplating raising drug-patent fairness issues and "the things drug companies use to keep generics out [of the market]."
The modernization act reauthorization could be a vehicle for comprehensive review of drug patents. But some aides warn that such controversial issues should not be loaded onto the pediatrics provision, lest it collapse under the political weight.
House and Senate Republicans have begun laying the groundwork for the reform bill and exploring how well the previous legislation has worked. "We've experienced a slowdown in drug approvals, and we want to find out why," said a spokesman for Energy and Commerce Chairman Tauzin.
Despite the primacy of drug issues, the modernization act went far beyond drugs, addressing how FDA regulates new medical-device technology--such as pacemakers and shunts, blood and tissue products, veterinary medicine reviews, and food and packaging substances.
"Anything anybody's been saving up for the past five years on drugs or devices, I imagine they'll look to this bill," said a Senate aide.
April 26, 2001