The Food and Drug Administration is being accused of abandoning science and giving in to political pressure to withhold approval of a generic version of the drug Premarin -- the most prescribed drug in the U.S.

Premarin's manufacturer, Wyeth-Ayerst Laboratories, a division of American Home Products Corp., reportedly orchestrated a strong lobbying campaign against the substitutes -- recruiting members of Congress including Senators Barbara Boxer (D-Calif.), Bill Bradley (D-N.J.), Olympia Snowe (R-Maine), Barbara Mikulski (D-Md.) and Patty Murray (D-Wash.) to write letters to the FDA, urging a halt to the generic drug's progress through the agency.

• Critics say using the substitutes for Premarin, which combats osteoporosis and eases the symptoms of menopause, could have saved consumers, Medicare, hospitals and managed care organizations almost $300 million a year.

• A typical Premarin regimen costs more than $400 per year.

• Until 1991, several alternatives to Premarin were either in production or on the market in the U.S. and Canada -- at which point the FDA pulled them off the market after dire warnings of cancer risks due to high rates of absorption in the bloodstream were issued by Wyeth-Ayerst.

• While other generic manufacturers left the market, two companies -- Duramed Pharmaceuticals and Barr Laboratories -- solved the so-called absorption problem, met the FDA's criteria, and were prepared to go to market in 1994.

Suddenly, however, the FDA said it needed to re-examine "new" evidence provided by Wyeth-Ayerst. The announcement was made after the CEO of American Home Products visited President Clinton at the White House and made a $50,000 contribution to the Democratic National Committee, according to reports.

On May 6, 1997 the FDA issued a statement denying approval to the substitute -- three days after an FDA internal document laid waste to Wyeth-Ayerst's charges against it and charged the agency with "reducing or eliminating the incentive to develop the necessary public health information."

Source: Tom Schatz and Leslie Paige (both of Citizens Against Government Waste), "Politics Trumps Science at the FDA," Wall Street Journal, July 21, 1997.

The Food and Drug Administration is still consistently failing to deny or approve medicines and other health products within the deadlines imposed by law, says Citizens for a Sound Economy Foundation.

For the second consecutive year, researchers compared FDA review times to legal requirements. For fiscal year 1996, they found:

• While the deadline for reviewing petitions to make claims about the health benefits of food products is 190 days, the FDA took an average of 258 days.

• Although the FDA is required to approve or deny new drug applications within 180 days, the agency took an average of 596 days for drugs it approved.

• Similarly, medical devices -- from bandages to pacemakers -- cannot be marketed until the FDA has declared them safe and effective, and the agency is required to approve or deny submissions in less than 180 days.

• However, the 43 applications for medical devices the FDA approved took an average time of 789 days, nearly four times longer than the law allows.

Thus healthful products weren't available to consumers as quickly as possible, asserts the study, and patients have suffered or even died while waiting for approval. For instance,

• A four-year delay in allowing health claims for the dietary intake of folic acid may have caused as many as 5,000 infants to be unnecessarily stricken with spina bifida.

• Information regarding the benefits of aspirin in preventing heart attack-related deaths might have saved 5,000 to 10,000 lives during each of the eight years the FDA kept manufacturers from informing consumers.

A 1992 reform law allows the FDA to use fees to speed up new drug approvals. While review times for new drug applications have shortened by a year, delays in average clinical development time have increased, so that patients are now waiting nearly one year longer for new drugs than before the reform.

Source: Michael F. Cannon, "The FDA's Report Card Shows Another Failing Grade," Issue Analysis No. 52, April 30, 1997, Citizens for a Sound Economy Foundation, 1250 H Street, NW, Washington, DC 20004, (202) 783-3870.