FDA Plans Reforms To Boost Drug Safety, Increase Communication
FDA on Tuesday announced several initiatives designed to improve prescription drug safety, including increased monitoring of adverse events after drugs have been approved and are on the market, the New York Times reports. The agency's initiatives come in response to a September 2006 Institute of Medicine report that recommended 25 changes to ensure the safety of prescription drugs (Harris, New York Times, 1/31).
FDA on Tuesday said it will establish a pilot program that will publish a "report card" that reviews the side effects, use and latest research on two or three new drugs 18 months after they reach the market (Wilde Mathews, Wall Street Journal, 1/31). FDA also will pursue the following actions:
- Collaborate with the Department of Veterans Affairs, CMS and private insurers to collect data on any problems that physicians and patients encounter with medications;
- Increase transparency in the process of how the agency selects advisory panel members (Vedantam, Washington Post, 1/31);
- Create a new advisory panel that will recommend ways for the agency to improve how it communicates with the public about potential drug risks (New York Times, 1/31);
- Publish periodic newsletters on its Web site to update the public on post-market reviews of medications;
- Implement organizational changes to improve communication between agency employees who monitor drug approvals and those who monitor post-market safety (Rubin, USA Today, 1/31);
- Modernize the "adverse events" database so that potential problems are easier to recognize (Alonso-Zaldivar, Los Angeles Times, 1/31);
- Renew the agency's focus on scientific endeavors, including the creation of a database of genetic codes associated with poor drug outcomes and developing screening tests to identify patients at highest risk for adverse events (New York Times, 1/31); and
- Appoint a chief medical officer to oversee scientific operations (Pugh, Miami Herald, 1/31).
FDA's proposals did not address a number of the IOM report's recommendations, some of which would require congressional action, the Times reports (New York Times, 1/31). For example, FDA did not say it would restrict direct-to-consumer advertising of new prescription drugs or require label changes that would alert consumers if treatments had been on the market for less than two years (Miami Herald, 1/31).
FDA Commissioner Andrew von Eschenbach said the agency considers the IOM report "a substantial amount of advice" but not a "rigid blueprint" (USA Today, 1/31). In its response to the IOM report, FDA said it "believes it has the statutory and regulatory authority needed to carry out its commitment to ensure drug safety," although it added that it needs more funding to do so (Wall Street Journal, 1/31).
Shelia Burke, chair of the IOM panel and the chief operating officer at the Smithsonian, said, "I would have wanted to see more formal involvement of the safety staff in the drug development process."
Bruce Psaty, an IOM panel member and a professor of medicine and epidemiology at the University of Washington-Seattle, said, "It looks like they are launching a number of initiatives to address drug safety," adding, "Many of them are new, so the degree to which they will improve safety remains to be seen, but I think it's a fairly comprehensive response" (Los Angeles Times, 1/31).
Alta Charo, a panel member and a professor of law and bioethics at the University of Wisconsin-Madison, called the FDA's announcement of new initiatives "a very serious effort to respond to the IOM recommendations. It's filled with a variety of first steps that go in the right direction." She added, "I have to confess I'm disappointed that they ignored one of our most critical recommendations" -- the suggestion that FDA give more authority to the Office of Drug Safety to regulate drugs after they reach the market (USA Today, 1/31).
Von Eschenbach said, "The initiatives we announce today are not the whole story, and they are not the final chapter in the story" (Los Angeles Times, 1/31). He added, "It's merely a step as we continue a process of improvement that will be ongoing" (New York Times, 1/31). He also said FDA is in "substantial agreement" with most of the IOM recommendations (Cohen, Newark Star-Ledger, 1/31).
Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) in a statement said, "Only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety." Kennedy is expected to introduce drug safety legislation with committee ranking member Michael Enzi (R-Wyo.) soon (Wall Street Journal, 1/31).
Sen. Christopher Dodd (D-Conn.) said he would introduce on Wednesday two bills, co-authored by Sen. Chuck Grassley (R-Iowa), that would reorganize FDA and require pharmaceutical companies to release the results of all human clinical trials (New York Times, 1/31).
Alan Goldhammer, deputy vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said, "The agency has made substantive and significant progress in improving and enhancing the drug safety system in the U.S." (New York Times, 1/31). He also said, "One thing we don't want to see happen is if patients get concerned and they decide to stop therapy and don't talk to their doctors" (Bridges, AP/Long Island Newsday, 1/31).
Consumers Union in a statement said that the changes fall "dramatically short of the changes needed to overhaul the nation's drug safety system" (Wall Street Journal, 1/31).