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Doctors back limits on advertising for new drugs

Posted in Pharmaceutical Advertising

I agree wholeheartedly.

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 The result is that, when drugs are withdrawn from the market over safety concerns, it is typically in the first couple of years they're on the market.

Source: Doctor group calls for warnings on new prescription drugs | Booster Shots | Los Angeles Times