Commentary: How Drugmakers Should Handle a Cautious FDA

By Amy Barrett

On Apr. 25, AstraZeneca PLC (AZN ) announced that the Food & Drug Administration was taking longer than expected to review its new cholesterol-lowering drug, Crestor. Five days later, Eli Lilly & Co. (LLY ) delivered similar bad news about its much-publicized erectile-dysfunction product, Cialis. Many other drug companies have been in the same predicament. Now, they're howling that the FDA--lacking a Commissioner since President Bush took office--has grown excessively cautious on new-drug approvals.

Unfortunately for drugmakers, this won't change any time soon. For one thing, complicated health-care politics will likely continue to stall the appointment of a new Commissioner. And even if a chief is named, the process of getting new drugs through the FDA is bound to remain troublesome.

To respond to this new reality, drugmakers must find ways to change their own research operations. And they need to open their wallets to help fund an improved drug monitoring system. Otherwise, stalled approvals will impair profits and prevent them from restocking their already-thin product pipelines. "This [tougher regulatory climate] can have a chilling effect on how drugs move through R&D," warns William A. Haseltine, chairman and CEO of Rockville (Md.)-based Human Genome Sciences Inc. (HGSI ), a developer of gene-based drugs. "It's like pouring molasses on the whole [system]."

Clearly, the pace of FDA reviews has slowed recently. In the case of standard drugs--those not considered high priority--the average time from filing an application to approval was 19 months in 2001, up from a low of 13.4 months in 1998. Dr. John Jenkins, director of the FDA's Office of New Drugs, lays the blame partly on resources: The workload has been going up, and funding hasn't kept pace. But industry sources say there's more to it than that. "The FDA has become more risk-averse," contends Pfizer (PFE ) Chairman and CEO Henry A. McKinnell.

That's easy to understand. The agency is still recuperating from a string of high-profile drug withdrawals over the past several years. One after another, products such as the diabetes drug Rezulin and Baycol, another cholesterol-lowering compound, had to be pulled from the market after patients who used them suffered sometimes-fatal side effects. But Jenkins says those withdrawals have given the agency more expertise in spotting problems such as liver toxicity. Last year, for example, Bayer had to withdraw Baycol after reports of 31 deaths in the U.S. from a muscle-related side effect. No wonder regulators are giving extra scrutiny to AstraZeneca's Crestor.

While there is no simple fix to the drugmakers' dilemma, certain measures could smooth the process. First, drug companies should hasten ongoing changes in their research operations aimed at weeding out problem drugs more quickly. Pfizer researchers, for example, are using new molecular biology tools to quickly spot and eliminate drug candidates that appear similar to compounds which cause liver or heart problems.

The industry also needs a more robust system for spotting dangerous side effects. Two months ago, the industry agreed for the first time to let the FDA take a portion of the fees it collects from companies and spend the money on surveillance of side effects in newly launched drugs. But that agreement will only cover drugs for two or three years after their roll-out, which is too short. A May paper in the Journal of the American Medical Association found that for drugs approved between 1975 and 1999, half of the dangerous side effects associated with those products were identified more than seven years after approval. In other words, the system for finding problems with new drugs is still inadequate. As long as that's the case, regulators can't be blamed for being overly cautious.

Barrett covers the drug industry from Philadelphia.

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