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).
IOM Recommendations, Comments 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).