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Drug approval; FDA dilemma: Too fast or too slow? Agency under pressure to say yes; however, public safety should rule.


MOST AMERICANS don't care whether their prescription drugs were approved on a "fast track" or slow lane, as long as the medicine is safe to take, does not cause troubling side effects and works.

The Federal Drug Administration is charged with ensuring the safety and effectiveness of prescription drugs. It has long been credited with providing Americans the world's safest medicines.

But a series of highly publicized drug problems -- and the withdrawal last year of three drugs from the market -- has left the public confused about the safety of the nation's drug supply. Critics publicly blame the FDA's accelerated drug approval process.

The latest controversy surrounds the FDA's handling of the diabetes pill Rezulin, which has been linked to more than 30 deaths and was approved by the FDA in spite of warnings from its own physician advisers.

Manufactured by Warner Lambert Co., the drug was pulled from the British market a year ago. The drug remains on the U.S. market, but users are required to undergo frequent blood tests to guard against liver damage.

Even the FDA's harshest critics agree there are legitimate reasons for speeding the approval of drugs that could treat critically ill patients. But public confusion over drug safety must be resolved quickly before the people's trust in the FDA is seriously undermined.

This can't be done while the FDA ignores the concerns of the doctors who review drugs for the agency. And it can't be done without a better way to spot dangerous drugs on the market than the current system of voluntary -- and haphazard -- reporting.

By bolstering its safeguards for identifying dangerous drugs, the FDA can reassure patients that their safety hasn't taken a back seat to fast-track drug approvals.

Pub Date: 1/26/99

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