If passed, the new bill would strengthen monitoring for approved drugs, require companies to deposit clinical trial data into registry
By Aaron J. Bouchie | August 8, 2006
Two U.S. Senators introduced last week (August 3) a bill intended to strengthen the Food and Drug Administration (FDA)'s ability to monitor drug safety for marketed products -- a hot topic since a series of high-profile recalls, including COX-2 inhibitors and Guidant?s pacemaker device.
The bill would also build on ClinicalTrials.gov, the government's clinical trial registry that is housed by the National Library of Medicine, by requiring the registration of all late phase 2, phase 3, and phase 4 clinical trials -- even those that report negative results. Companies would also be required to deposit the data from such clinical trials, along with technical and lay summaries. Data from phase 2 trials would not need to be submitted if they contain commercially sensitive information.
The Enhancing Drug Safety and Innovation Act of 2006 was introduced by Senators Mike Enzi (R-WY) and Edward Kennedy (D-MA).
Greg Simon, president of the biomedical think tank FasterCures in Washington, DC, said he approves of the clinical trials portion of the bill, given that companies often don't report bad data. "Replicability is the foundation of the scientific process. If they don't make the data public, then it isn't science," said Simon, who was the chief domestic policy advisor to Vice President Al Gore from 1993-1997.
Peter Pitts, president of the non-profit Center for Medicine in the Public Interest, disagreed, noting that the decision to make data public should be left up to the FDA, not mandated. "The FDA needs more money to do the job of its current authority," said Pitts, former assistant commissioner of the FDA from 2000-2002.
The Enzi-Kennedy bill also aims to improve the FDA's process for screening advisory committee members for potential financial conflicts of interest. The FDA announced similar efforts last month.
The FDA currently has few options if a marketed drug shows signs of being unsafe. It can request a company to change the label on the drug, which can turn into a lengthy court process. Or the FDA can issue a recall, a drastic action that is rarely used.
The legislation would require all new drug applications to contain a risk evaluation and mitigation strategy (REMS) that lays out a post-marketing safety surveillance plan before the drug is approved.
Another two billsintroduced by Senators Grassley (R-IA) and Dodd (D-CT) address similar issues, but mandate the publication of all clinical trial data, except for phase 1 safety trials. The Enzi-Kennedy bill is slightly more friendly to industry, in that it will not require all phase 2 trial data to be made public, but its penalties are much stiffer for non-compliance: up to $250,000 per violation versus $10,000 in the Dodd bill.
The Enzi-Kennedy bill would also establish a public-private partnership to speed the development of a new generation of predictive tools to increase safety and speed product development.
There is likely too little time for this bill to pass into law in this session of Congress, Bert Rein at the Washington, DC-based law firm Wiley, Rein & Fielding LLP, who has expertise in healthcare law, told The Scientist. "This is a complex matter, so the senators are exposing it to public discussion now. They will probably try to get a hearing and see what the public says, see what industry says, and then adjust the text and bring it back to the next Congress," Rein predicted.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization for pharmaceutical companies, issued a statement last week that it was reviewing the legislation, and declined to comment to The Scientist.
Aaron J. Bouchie
Links within this article
Enhancing Drug Safety and Innovation Act of 2006
R. Gallagher, "Pharma should publish its results," The Scientist, April 26, 2004.
K Fodor, "Trials of the pharmaceutical industry," The Scientist, November 22, 2004.
A Ault, "House berates FDA, drug makers," The Scientist, September 10, 2004.
Center for Medicine in the Public Interest
A McCook, "Conflicts of interest at federal agencies," The Scientist, July 24, 2006.
Food and Drug Administration Safety Act of 2005
Wiley, Rein & Fielding LLP