FDA Takes Its Medicine

by on February 16th, 2005

Months after top Food and Drug Administration scientists accused the agency of slow or no response to dangerous drugs it approved, the FDA is finally getting around to setting up a drug safety panel. The Drug Safety Oversight Board watch for dangers that crop up after a drug is approved and on the market — problems their current review panels miss.

Drug companies can pay higher fees to get quicker approval for new drugs from the FDA. Critics say that rushes new medicines through — before they can be fully tested.

Scientists have complained that once problems crop up with a drug already on the market — the FDA is slow to pull the drug. Some scientists have testified before Congress that their superiors threatened them with firings or other punishments for calling attention to such problems.

The FDA announcement comes on the eve of a major scientific conference set to discuss problems with two such drugs — Vioxx and Celebrex. The prescription pain killers were sold with FDA approval for years before research turned up showing they could cause heart attacks.

Critics say the FDA’s new plan isn’t enough. And you have to question the timing. The FDA has gone looking for praise and made some high profile, populist calls at critical times in the Vioxx mess that seemed custom made to deflect their bad press.

That makes the timing this time — a tough pill to swallow.

[Crossposted at Watching Washington]

Terry Turner