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Drug Companies Say That FDA Has Tightened Its Regulations

By Andrew Pollack
THE NEW YORK TIMES

A federal advisory group last week derided the Food and Drug Administration as a feckless watchdog unable to protect consumers from unsafe medicines. But try telling that to drug company executives, investors and analysts.

Many of them say the FDA has already responded to a barrage of criticism over the last two years by quietly becoming more assertive about keeping new drugs off the market or refusing to approve new uses for existing medications.

The Nasdaq Biotechnology Index is down about 14 percent since late February, in part on Wall Street’s perception that the FDA has become a tougher gatekeeper.

“The uproar that’s occurred in the wake of Vioxx has clearly had an effect on the way the FDA approaches its work,” said Ira Loss, who follows the FDA for Washington Analysis, a firm that monitors the federal government for investors. “The agency doesn’t hesitate to say ‘No’ or ‘Send me more data.”’

Loss was referring to the market withdrawal two years ago of Merck’s painkiller Vioxx for safety reasons. That episode ignited criticism of the FDA and prompted the agency to commission the report issued last week by the federal advisory group, the Institute of Medicine.

Despite the report’s critique, executives and analysts point to numerous unexpected delays and rejections by the FDA since the Vioxx debacle that they say show the agency is taking a tougher stance.

Earlier this month, for instance, Genentech said approval of its colon cancer drug Avastin as a treatment for breast cancer would be delayed about a year because the FDA had asked for more data. Genentech said the agency appeared to be toughening its requirements for certain types of clinical trials.

And some drugs that won approval in Europe have only received “approvable” letters from the FDA, meaning they will not be allowed on the market without more information. These drugs include Sanofi-Aventis’ Acomplia for obesity, NPS Pharmaceuticals’ Preos for osteoporosis and Encysive Pharmaceuticals’ Thelin for pulmonary hypertension.

Also, whether from caution or a lack of manpower, it has become common for the agency simply to postpone decisions by 90 days. About half a dozen drugs, including Pfizer’s inhaled insulin, Exubera, that have been approved in the last several months were first subjected to 90-day delays.