Fw: F.D.A. Seeks Quicker Approval of New Drugs, Med Devices

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http://www.nytimes.com/2002/12/12/health/12DRUG.html

F.D.A. Seeks Quicker Approval of New DrugsBy ROBERT PEAR

ASHINGTON, Dec. 11 — The new head of the Food and Drug Administration, Dr. Mark B. McClellan, said today that he intended to speed the approval of new drugs and crack down on deceptive pharmaceutical advertising.

The agency has substantially reduced the time required to review and approve new medicines since 1993, when drug companies began paying fees to help cover the costs of such reviews. It still takes a little more than a year for the agency to approve a typical brand-name drug, and Dr. McClellan said today, "We can do better."

Dr. McClellan said he wanted to accelerate the approval of both brand-name and generic drugs, as well as medical devices.

"We have some great opportunities to do better in drug approval times and in getting products that are safe and effective to market more quickly," Dr. McClellan, a physician and economist who worked at the White House until he took charge of the agency on Nov. 14, said.

User fees paid by drug companies accounted for about half the $332 million that the agency spent on drug reviews in the last year.

Told of Dr. McClellan's commitment to speed the review of low-cost generic versions of brand-name drugs, Jake Hansen, vice president of Barr Laboratories, a large maker of generic drugs, said, "That's music to our ears."

Currently, Mr. Hansen said, "the decision on approval of a generic drug is supposed to be made within six months after an application is filed, but it's not at all unusual for the process to take 14 to 16 months, which is longer than the time needed to approve many brand-name drugs."

Some consumer groups assert that quicker review of new drugs has increased the risk that products will later be found unsafe and removed from the market. Some studies have found such an increase, but the agency disagrees.

Dr. McClellan said his agency would be more aggressive in policing claims made in television advertisements for prescription drugs.

"We will not be afraid to go to court when necessary" to stop companies from exaggerating the benefits or understating the risks of drugs, he said.

Since 1997, the agency has sent more than 88 letters to drug companies objecting to their advertisements on television and radio and in print.

The General Accounting Office, the investigative arm of Congress, reported last week that several major companies had repeatedly disseminated misleading advertisements for the same drug even after being cited for violations.

Dr. McClellan said he would try to deter violations by setting clearer standards.

"If we see patterns of recurrent use of misleading techniques in advertising," he added, "we will go further than warning letters."

The commissioner said he was even more concerned about misleading claims for the health benefits of some dietary supplements. "I am looking for ways to improve our enforcement" in that area, he said.

Dr. McClellan also said that with the rapid growth in drug development, "there's a real problem" getting enough people to participate in clinical trials of new medications. New technology, he said, may allow researchers to predict a drug's side effects at an earlier stage, alerting the government and industry to potential problems, like liver damage, without waiting for the results of lengthy clinical trials with large numbers of patients.

In addition, Dr. McClellan said he wanted to negotiate arrangements with some hospitals and nursing homes so they would automatically and promptly report the adverse effects of drugs and medical devices already on the market.

Dr. Woosley, a pharmacologist who is vice president of the University of Arizona, called such surveillance an excellent idea.

"It would indicate what proportion of patients exposed to a drug suffer adverse effects," Dr. Woosley said, "and we could use that information to measure the relative safety of different drugs.

The government receives vast amounts of information about the adverse effects of drugs on the market. But the reporting by doctors and patients is generally voluntary, and the government usually has no idea how many people have been exposed to a particular drug.

Dr. McClellan said he did not intend to weigh the costs and benefits of new drugs submitted to his agency for approval.

"That's not part of our mandate," he said. "But I would like to do some additional cost-benefit analysis of our drug approval process. If there are different ways of assuring that a safe, effective drug gets to market, we ought to follow the approach that does it as efficiently as possible, at the least cost to the agency and the drug producers."