FDA Chief Warns of Risks in Rushing New Drugs to Market

Faster reviews of new medicines bring quicker benefits to patients but also may lead to more drugs being pulled from the market, the head of the U.S. Food and Drug Administration said Tuesday.

FDA Commissioner Jane Henney said U.S. approval time for novel medicines has shrunk from an average of about 30 months eight years ago to about 12 months today. Urgently needed treatments come to market in about six months, she said.

In the agency’s slower days, European countries often brought drugs to market first, and any early signs of trouble appeared there.

Now, the U.S. often is first to the market. In 1998, three-quarters of all new drugs debuted in the U.S., which means U.S. regulators cannot look to other countries’ experiences, Henney said.

Unexpected reactions can occur once drugs hit the market and are used by a wide range of people without the close monitoring of a scientific trial, Henney said.

Consumer groups have criticized the FDA amid 10 drug recalls since 1997, including three this year.

Critics say the agency’s speedy evaluations are compromising patients’ safety.