ACCIDENTAL DRUG DEATHS: FDA Looks at New Regulations
Spurred by recent reports that more than 100,000 Americans are accidentally killed by prescription drugs each year, the FDA, working in conjunction with drugmakers, the AMA, hospitals and consumer groups, has launched a new initiative to protect consumers. "More can be done" to ensure the safety of the public, FDA Commissioner Dr. Jane Henney said, adding that some of the changes "will be tremendous." The Los Angeles Times reports that the FDA will unveil the proposal today in a 150-page document. Some specifics include:
- An $8 million computer system upgrade that will allow the nation's 13-largest drug companies to immediately report any unforseen reactions to licensed drugs.
- An international agreement with regulators in Japan and Europe to "use the same terminology to describe drug reactions or causes of death so that global trends can be more clearly and rapidly identified."
- A clearer drug information and precaution format for doctors. The drug industry worries that the system in particular will increase liability. Marjorie Powell, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said, "I don't think it's possible to condense all the key information on prescription drugs into such a simplified, standardized format." But Nancy Ostrove, an FDA official involved with the new regulations, said, "Their concern is that by highlighting certain information it will discourage prescribers from reading the rest. We don't believe that, because we think they aren't reading it now."
- The FDA will designate up to 10 new products each year that are dangerous enough to carry new, easy-to-understand warning labels for consumers.
- New computer networking designed to spot confusion over new drug labelling. Dr. Janet Woodcock, director of the FDA's center for drug evaluation and research, said, "We have the ability to forbid a name that's too similar -- we do turn down names -- but we can't always do as close a review as we'd like. We need computers to do name comparisons in advance."
- Designating hospitals to "monitor and report" adverse drug reactions in patients.
The FDA stresses that despite the new regulations, it cannot regulate how physicians prescribe drugs, how pharmacists dispense them, or how patients use them. But Woodcock said the new rules are "the first step toward trying to reduce those deaths -- because we think it can be done" (Cimons, 5/10). This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.