The nation's leading group of general internal medicine physicians has taken the U.S. Food and Drug Administration to task over drug safety and urged the agency to adopt a raft of new consumer safeguards for prescription drugs.
The American College of Physicians recommended that the FDA place limits on the advertising of newly approved drugs to the public, and require that prescription drugs that are new to the market bear a symbol alerting consumers to that fact. The internists also urged the agency to improve its system of detecting drug-safety problems once a newly approved drug is in broad circulation, and said the agency must do a better job of monitoring the safety of drugs manufactured abroad.
The first years of a prescription drug's availability can be boom times for manufacturing giants, who generally "roll out" a new FDA-approved drug with a flashy and expensive marketing campaign aimed at doctors they hope will prescribe the drug and patients they hope will ask for it by name. Those efforts often make new drugs "blockbusters" soon after they reach the general patient population.
The problem: The general patient population is generally less healthy, more diverse, less careful about following use instructions and on more other medicines than were the subjects the drug companies used in their preapproval clinical trials. As a result, safety and effectiveness problems are sometimes detected only when a drug goes into wide circulation. The result is that, when drugs are withdrawn from the market over safety concerns, it is typically in the first couple of years they're on the market.
That's a perspective lost on many American consumers, who tend to reach for their wallets when they see a label proclaiming a product "New!" Advocates of stricter warnings say that an FDA new-drug symbol should serve as a warning that the product still has a limited track record of safety in a general population.
The example generally cited as Exhibit A in support of such proposals is Vioxx, the arthritis pain reliever withdrawn from the market by Merck after post-marketing reports and company studies found the drug greatly increased stroke and heart attack risks. The withdrawal, however, came after an aggressive marketing campaign had made the drug one of the bestselling pain pills on the market.
But limits on the advertising of new drugs, as well as a "new drug" symbol, would likely require a go-ahead from Congress, and both initiatives would face stiff resistance from drug manufacturers and advertising interests. Both have charged that advertising restrictions on drugs that has passed FDA muster would trample free-speech rights and deny patients the right to inform themselves of a legal medical option.
-- Melissa Healy