By Lisa Seachrist

Washington Editor

WASHINGTON — As a send-off for FDA Commissioner David Kessler who is leaving his post at the end of this week, the Competitive Enterprise Institute — a think tank based in Washington — presented a report citing that, in contrast to recent reports by the agency, the FDA still approves drugs at a much slower pace than other countries.

"These claims are contradicted by reality," said Julie DeFalco, a policy analyst at CEI and author of the report. "Case after case demonstrates that the FDA regulations have kept valuable medicines out of the reach of Americans who need them."

The institute did not present overall statistical evidence of a trend in lengthy review times. Instead, the report studied the process case by case.

DeFalco highlighted several drugs that suffered delays at the agency. For example, she cited taxotere, a treatment for breast cancer that was submitted to the regulatory agencies in Canada, Europe and the U.S. at the same time. The drug was approved in one year in Canada, 16 months in all 15 countries of the European Union and in almost two years in the U.S.

"Yet the FDA claims that Taxotere represented accelerated approval," DeFalco said. "If the agency considers a two-year approval time for a major cancer drug accelerated, then this does not bode well for drugs of lesser importance."

DeFalco's most outrageous example came with a stroke drug called Ancrod. Ancrod has been available in the U.K. for 23 years. She said that in 1979, a General Accounting Office report stated that Ancrod should be made available in America as soon as possible. "Ancrod is currently in clinical trials in the U.S.," DeFalco said.

Don McLearn, a spokesman for the FDA, called CEI's claims "ludicrous" noting that in any collection of drug approval times there are going to be a few outliers. "I suspect that the group looked at the approval times for those drugs and highlighted the extremes," McLearn said.

Drug approval times have, instead, dropped dramatically, McLearn noted with 139 new drugs and biologics approved in 1996.

"Even industry representatives are flabbergasted with the increase in drug approvals," McLearn told BioWorld Today.

McLearn even suggested that CEI may have missed an overall sea change in discussion from drug approval times to drug development times. "Our discussion with Pharmaceutical Research and Manufacturers of America have been on drug development time, not drug approval times," McLearn said. "And, we are working to address those problems."

Sam Kazman, general counsel at CEI, noted that drug delays whether from development delays or approval delays have as many negative consequences as putting a dangerous drug onto the market. "People die when a dangerous drug is on the market," Kazman said. "But, what many people don't recognize is that sick people die waiting for good drugs that are delayed at FDA."

Kazman noted that there are two errors that a drug reviewer can make. The first is to approve a drug that harms people. The second is to fail to approve a drug that could benefit people. "All of the political incentive is to make sure that you don't approve a dangerous drug," Kazman said. "But, that leads [the FDA reviewers] to deadly overcaution."

Kazman maintained that the only way to combat this culture and make drugs available to Americans in a timely fashion is to abolish "FDA's veto power." Kazman would have the agency become certificatory in nature rather than regulatory nature.

Freedom Of Choice

"People who think that FDA does a good job could choose to use only FDA approved drugs," Kazman said. "Those who would like to have access to other therapies could do so under medical supervision."

However, Joseph White, a visiting fellow at Brookings Institute, a think tank in Washington, disagreed. "The argument is often made that desperately ill people should be able to take any medication that they want because they are going to die anyway," White said. "But, are desperately sick people necessarily in a position to be the best consumers of drugs?"

White said that regardless of problems in approval times at the FDA, it still garners worldwide respect.

"I know of no civilized country that uses the market as its approval process," White said. "And, I am quite sure the American public wouldn't approve of such a change."

Carl Feldbaum, president of the Biotechnology Industry Organization (BIO) noted that in the "last two years, the agency has made some incremental progress under Kessler."

However, Feldbaum concurred that CEI's proposal as inviable and potentially polarizing. "It would not surprise me if Congress and the public found that unacceptable at this time," Feldbaum said. "A strong, independent and efficient FDA is in the best interest of our industry." *

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