This column was originally published in AMA eVoice on October 4, 2007. Dr. Davis is president of the American Medical Association.
Physicians and patients recorded an important victory last week when legislation reauthorizing the Prescription Drug User Fee Act, which was set to expire Sept. 30, was signed into law. Known as the Food and Drug Administration (FDA) Amendments Act of 2007, the new law also reauthorizes the Better Pharmaceuticals in Children Act and the Pediatric Research Equity Act.
The new law improves the FDA's ability to ensure drug safety by enhancing post-marketing surveillance, and by giving the FDA the authority to require necessary post-marketing safety studies. It calls for greater transparency in clinical research by requiring that all clinical trials be cataloged in a clinical trials registry, and that information about the results of these trials be made public.
The new law continues to ensure patient access to medically indicated drugs, and it does not unduly limit the discretion and professional judgment of physicians to make determinations about the needs of their individual patients. The AMA worked with Congress, in particular U.S. Sen. Tom Coburn, MD, R-Okla., to make this legislation the best it could be for physicians and patients.
Ensuring drug safety is a collaborative effort, and the AMA looks forward to working with Congress, the FDA, medical specialty societies, state and county medical societies, and others to better serve America's patients and physicians by providing the best means for identifying drug risks and communicating them to physicians and the public.
The FDA is now providing physicians with electronic tools to help improve drug safety. Physicians can do their part to stay updated on safety information concerning the medical products they prescribe or use by subscribing to the FDA's MedWatch listserv notification, and by accessing RSS news feeds by bookmarking the FDA's MedWatch Web site. Various audio broadcasts also are available to be downloaded.
The FDA also recently launched the Drug Safety Newsletter, which provides information about emerging drug safety issues, recently approved new drugs, and other important safety information.
In addition, updated prescription drug labels (package inserts) now are available free of charge to physicians through the National Library of Medicine's DailyMed Web site.
But here's something that will probably come as a great surprise to you—many unapproved drugs have been on the market in the United States for many years. As I said in a CNN interview last week, most—if not all—doctors assume that if a medication is on the market, it must have been approved by the FDA, and, therefore, must be safe and effective. Yet that's not always the case. The FDA estimates that up to 2 percent of drugs on the market are not FDA-approved, which raises serious questions about the relative safety and efficacy of these products.
Physicians generally are unfamiliar with the history of U.S. drug law, and—for a variety of reasons—it's unlikely they know which drugs on the market are not FDA-approved. As a first step toward greater awareness, the FDA should provide physicians (and the public) with a list of all unapproved drugs currently on the market.
In the meantime, the FDA should continue to work expeditiously to assure that manufacturers comply with contemporary regulatory requirements for drug approval. If an unapproved drug has been shown to be either ineffective or unsafe but is still on the market, that drug should be removed from pharmacy shelves. Because some very useful but unapproved drugs with a long history of safety and efficacy might remain on the market, the FDA may need to be flexible in applying the standards necessary to bring these drugs into regulatory compliance.
On a separate note, I'd like to applaud efforts by the AMA and other medical societies to secure a six-month delay of a federal requirement that handwritten Medicaid prescriptions must be written on tamper-resistant prescription pads. The requirement originally was to have taken effect Oct. 1, an unreasonable target date that could have harmed Medicaid patients' access to prescribed drugs. A key component of advocacy on this issue was a letter the AMA signed, along with dozens of state medical societies and national medical specialty societies, urging the U.S. Department of Health and Human Services to delay and further consider the mandate.
The AMA will continue to advocate for policies that improve patient safety, preserve physician autonomy, and help us better serve patients. And we'll continue to be vigilant concerning federal drug policies—and be willing to take action when appropriate.
Please send comments, questions, and replies to amaprez@ama-assn.org.
Content provided by: Ronald M. Davis, MD