FDA Tries to Find Right Balance on Drug Approval

Wall Street Journal, Tuesday, April 20, 1999

Rochelle Sharpe, Staff Reporter

This article discusses many problems at the FDA. A basic problem is that the FDA is caught between two political pressures:
    (1) Industry and the political right demand that drug approvals be speeded;
    (2) Consumer groups and the political left demand that the FDA show more caution.

FDA scientists are facing tighter deadlines for drug reviews, but funding has been flat for six years. Many experienced scientists are leaving, partly due to retirements, but often due to bad working conditions. For example, Ralph Harkins, who headed a major statistical division, retired because he was not getting needed support. More than one-half of 22 statisticians, who were working more than 12 hours per day, have left since 1998.

In 1993 the FDA began receiving user fees from the pharmaceutical industry in order to speed drug approval. Consequently, the time for final review of drugs has been reduced from 30 months in 1993 to 15 months. However, some FDA scientists are concerned that this has compromised drug safety and resulted in "approval creep" - encouraging reviewers to find any way whatsoever to approve a drug. As an example, Schering Plough's new drug, Cedax, was approved despite being ineffective against three major pathogens found in childern's ear infections and being less effective than other drugs already on the market. This prompted a complaint from the Center for Disease Control. There is also the problem that although user fees have speeded the approval of new drugs, there is not enough funding to examine the safety of existing drugs.

President Clinton wants to increase the FDA budget, but any extra money may go to defense and education. There are few lobbyists in Congress for the FDA. Businesses don't want more regulation, and some members of Congress hold grudges against the FDA because they disliked former Commissioner David Kessler, who tried to get tobacco regulated as a drug.

The article concludes with a statement by Peter Burton Hutt, former FDA Counsel, "We are slowly strangling the FDA to death."