Washington Editor

WASHINGTON - The U.S. military wouldn't purchase weapons from manufacturers based on a maker's political ideology or preliminary test data, so why is the Bush administration allowing the FDA to make its decisions on such flimsy, subjective information?

Rep. Henry Waxman (D-Calif.) posed this question and a number of others Tuesday to publicly verbalize his opposition to and concern with certain Bush policies within the FDA. Waxman, known around the drug industry as co-author of the Hatch-Waxman Act of 1984 that created the generic drug industry, addressed a captive crowd of lawyers, consultants, federal employees and drug company representatives at the 46th annual Education Conference of the Food and Drug Law Institute held here.

One of two keynote speakers, Waxman had the floor before the other keynote speaker, Mark McClellan, FDA commissioner. Upon taking the microphone, McClellan thanked Waxman for not sugar-coating his message.

And indeed he didn't. Waxman clearly holds strong views about the way drugs are approved and who is approving them. He believes some drugs are making it into sick bodies before companies have proved safety and efficacy.

When asked by an audience member how he could justify refusing a desperate cancer patient an unapproved medication, Waxman said patients in that scenario can participate in clinical trials or early access programs. Also, the agency's policy on approving breakthrough AIDS drugs seems to have worked well, but that doesn't mean other drugs should be approved without full data and test results, he said.

Waxman went on to accuse the Bush administration of letting its ideology impact the FDA. Case in point, he said: Bush's selection of W. David Hager to head the FDA's Reproductive Health Drugs Advisory Committee. (Hager is a physician at the Women's Care Center in Lexington, Ky.)

"This appointment appears to have to do with [Hager's] opposition to abortion," Waxman said. "This is a physician who tells women to read scripture for PMS and a physician who will not prescribe contraceptives to unmarried women.

"Many people say this is just an advisory panel appointment," Waxman said. "These panels have more of an impact than one might think."

Advisory panels are comprised of experts in a given field who make recommendations (drug approvals, clinical trial design) to the FDA.

Waxman believes the FDA has misstepped over the years in certain drug approvals, like hormone replacement therapy (HRT) for menopausal women.

Not specially addressing HRT, when he got his turn at the podium, McClellan said adverse events or other effects of drugs often don't begin to surface until a product has been approved and introduced into the general public.

Rather than spending an hour defending his position and that of the Bush administration against Waxman, McClellan spoke about progress on new policies and initiatives at the FDA.

Among the key points, McClellan wants to speed the drug approval process so that the FDA doesn't unintentionally add to the rising costs of drugs and biologics by forcing companies through one or more review cycles.

Citing a Tufts University study, McClellan said it now costs more than $800 million to bring a "truly new" drug to market - more than twice what it cost a decade ago. And according to FDA figures, last year the number of new drugs and biologics approved was at the lowest level since the Prescription Drug User Fee Act was implemented in 1992.

Last year, the FDA approved 21 new molecular entities (truly new drugs), down from 44 such entities in 1996. And the FDA approved 12 new biological license applications, down from 27 BLAs in 1998.

Bearing in mind the costs of drug development and the declining number of new annual approvals, McClellan said policymakers should adopt reforms that encourage innovation rather than stifling it.

Two specific examples can be found in the generic drug program and the president's proposed Project BioShield.

First, generic drugs, a favorite topic of Waxman's.

Several members of Congress have sought to reform Hatch-Waxman through various forms of failing legislation. A particularly offensive loophole in the law, some contend, allows brand-name companies to stack automatic 30-month extensions on patents.

Similar to other legislation that has failed, the Bush administration introduced an FDA rule that would limit companies to one extension per patent and would restrict patents to active ingredients, drug formulations and uses of a drug. (See BioWorld Today, March 7, 2003, and Oct. 22, 2002.)

The rule is expected to be finalized this spring.

Because of their complexity, biologics have never been included under Hatch-Waxman. However, generic drug makers have made no secret that they have an eye on biologics.

If that's the case, generic makers likely will not receive support from McClellan. Responding to a question following his speech, McClellan said the science related to developing biologics is just too complex to try to include them under a generics rule.

But that is certainly not the case when addressing the president's Project BioShield, a program aimed at funding swift development of biomedical countermeasures. (See BioWorld Today, March 28, 2003.)

"Monoclonal antibodies have changed therapies and we believe they could be used for countermeasures," McClellan said. "The smallpox vaccine we are stockpiling is based on outdated technologies that are decades old. Research in monoclonal antibodies could give us the countermeasures we need."

Unfortunately, he said, companies are worried about investing millions of dollars in developing a countermeasure that will not net a financial reward.

The Senate Health, Education, Labor and Pensions Committee unanimously approved Project BioShield. Two House subcommittees discussed the legislation last week, but have yet to cast votes on it.