The Senate passed a bill on May 9 that would give the FDA more control over the safety of the drugs it approves.
Under the FDA Revitalization Act, the FDA would establish a surveillance system to track the adverse effects of prescription drugs and could require drug makers to conduct post-market safety studies. Currently, the FDA can request such studies but cannot require them. It also gives the FDA the authority to change drug labels, rather than request pharmaceutical companies to make changes voluntarily, as is currently done.
The original purpose of the legislation was to renew, through 2012, a program that involves collecting user fees from industry to pay for part of the drug approval process. The FDA's authority to do this expires on Sept. 30.
Chief bill sponsors Edward Kennedy (D-MA) and Mike Enzie (R-WY) and others used this renewal as an opportunity to overhaul the drug safety process at the FDA. The measure doubles fines to up to $2 million for companies who violate the FDA system for monitoring drugs in the first few years after they are approved.
Companies would also be required to register clinical trials of new drugs in a publicly available database — ClinicalTrials.gov, which was established as part of an FDA bill passed in 1997. This new bill would expand the database to include links to peer-reviewed literature and FDA information on drug trials.
An amendment that would have legalized drug imports from Canada did not pass in the final form of the bill, nor did a provision for setting a two-year moratorium on direct-to-consumer advertising of newly approved drugs. Instead, the FDA could impose fines of up to $150,000 for companies that do not include clear warnings of possible adverse effects in their drug ads.
The bill includes many of the recommendations proposed in a September 2006 report by the Institute of Medicine, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” (www.iom.edu/CMS/3793/26341/37329.aspx). The IOM report offered 25 strategies for improving FDA drug monitoring, including requiring post-marketing surveillance. Yet one of the recommendations — that the government increase FDA funding — was not addressed in the bill.
Ralph Sacco, MD, chair of neurology at the University of Miami and a member of the FDA Peripheral and Central Nervous System Drugs Advisory Committee, said the proposals are promising but will work only if they are funded adequately. “The question is do we pay for it with taxes or do we cut profit margins in the Pharma industry to help pay for it.”
According to Christopher-Paul Milne, DVM, MPH, JD, associate director of the Tufts Center for the Study of Drug Development, the bill will increase industry user fees by $25 million in 2008 to $65 million in 2012. This would average out to an increase of about $45 million a year, or 10 percent.
“That's a hefty increase, but when you consider that the prescription medicine market in the US is on the order of several hundred billion, the industry in the aggregate can afford it,” he said. “However, an increasing percentage of new drugs is being brought to market by small- and medium-sized entities. If it's your first product on the market or you only have a few revenue-generating products, every add-on to the regulatory burden hurts.”
Dr. Sacco said it's important for the FDA to expand its post-marketing surveillance. “Most of the post-marketing surveillance is not done as effectively and as rigorously as the pre-approval process.”
The House has not yet taken up a companion bill.