Biotech and FDA: Blame Game

ANDREW POLLACK / NY Times 16dec02

It's been a tough year for the biotechnology industry, with plunging stock prices, widespread layoffs, shortages of cash, a major scandal and numerous failures of drugs in clinical trials. When industry executives look for a source of all the troubles, they often point to the Food and Drug Administration.

The agency, industry executives often complain, has become too cautious in approving drugs. In part, they say, the situation is a result of the agency's having been leaderless for most of the Bush presidency. And the division that handles many biotechnology drugs has been particularly slow and short of employees.

But much of that might change in 2003. Mark B. McClellan, a physician and economist, took office last month as the F.D.A. commissioner and has pledged to speed up drug approvals.

"There's a lot of optimism," said Carl B. Feldbaum, president of the Biotechnology Industry Organization, the industry's main lobbying group. "We've been through this long period since the Bush inauguration of a headless agency, and that's over."

Also, under a recently announced reorganization, protein drugs, the type typically developed by biotechnology companies, will now be regulated by the same division that handles the chemical drugs made by big pharmaceutical companies.

That could mean speedier reviews, but in the short run lead to an exodus of top regulators from the agency. Kathryn C. Zoon, the director of the division that regulates biotechnology products, told colleagues on Friday that she is leaving to join the National Cancer Institute, in part because of the reorganization, according to current and former F.D.A. officials.

Only 15 novel drugs had been approved through late November this year, down from 24 for all of 2001 and from 53 in 1996. The time taken to approve drugs, which fell sharply during most of the 1990's, has edged up a bit in the last two or three years.

F.D.A. officials acknowledge that they are paying more attention to interactions among drugs and to certain side effects, including one associated with irregular heart rhythms, as knowledge of those side effects has grown. But the falloff in drug approvals, they contend, stems mainly from a decline in the rate at which the industry is coming up with new drugs, a slowing that many industry executives acknowledge.

Some say that the agency is being made a scapegoat and that the real problem is that companies are rushing their clinical trials and producing inadequate data. "I don't think there's ever been a time when the industry isn't whining about the F.D.A.," said Ira S. Loss of Washington Analysis, a research company specializing in regulatory matters.

The most notable example was ImClone Systems, whose application for a cancer drug was rejected by the F.D.A. on grounds that the tests were sloppy. Still, the rejection and ensuing insider stock trading scandal and Congressional investigation focused attention on complaints that the F.D.A. was denying drugs to cancer patients who had no other hope.

Other companies with setbacks include Genentech, which was told to do more study on drugs for psoriasis and asthma. Competing drugs by Genzyme and Transkaryotic Therapies for Fabry disease, a rare inherited disorder, have not been approved, although they are available in Europe. Shares of Alkermes plunged after it and Johnson & Johnson failed to win approval for Risperdal Consta, a longer-lasting version of an existing schizophrenia drug, because the F.D.A. had concerns about tests done in animals.

Executives and analysts will be watching the agency closely next year as it rules on many of the drugs, like Amevive, Biogen's psoriasis drug that was recommended for approval by an advisory panel in May.

Another closely watched case will be that of Iressa, a pill to treat lung cancer developed by AstraZeneca.

The reorganization of the F.D.A. will shift protein and antibody drugs from the division that handles biologic products — those made from living things — to the division that handles more conventional drugs.

The announcement was initially welcomed by the industry. But now executives are concerned that F.D.A. officials with expertise in biologic drugs, unhappy at the reorganization, will leave. In addition to Dr. Zoon, who was in charge of all biologic products, Jay P. Siegel, who was in charge of reviewing protein drugs, also announced that he would retire. He cited the revamping as a reason.

"My concern is that they not lose the people with biologics expertise," said William H. Rastetter, the chief executive of Idec Pharmaceuticals.

Mr. Loss said regulating biologic drugs in the same department as chemical drugs could eventually hurt the industry by undermining the argument that biologic drugs are so complex that generic versions should not be allowed.