The Food and Drug Administration proposed this week to disclose more information about safety problems with the drugs and devices it rejects. This is the latest step in the agency’s efforts to combat criticism that it has become too secretive in its dealings with drug makers and food processors. There is good reason for some secrecy — the FDA acquires a large amount of proprietary information, such as drug ingredients and food recipes, that it must protect from competitors. But in the past few years many believe the agency has gone overboard in declaring too much of its investigation process as being off limits to the general public. This secrecy keeps consumers from learning quickly about drug safety issues.
Criticism of the FDA really heated up in 2004, when the painkiller Vioxx was pulled off the market five years after it had been approved by the agency. Links were discovered between Vioxx and heart attacks and strokes. Critics said lives could have been saved if the agency had been more open.
Under the new proposals, the FDA would begin publishing rejection letters to drug and device manufacturers, including any safety concerns that led to the decision. Drug company lobbyists are of course opposed to the new proposals.