The Politics of Pharmaceuticals

by Judy Mann

Wednesday, April 2 1997; Page E13
The Washington Post

Premarin, which is made from the urine of pregnant mares, is a hormone replacement therapy taken by about 8 million American women every day to treat symptoms of menopause and to ward off bone loss.

It is the most widely prescribed drug in the country and generates nearly $1 billion a year in revenue for its maker, Wyeth-Ayerst, and its parent company, American Home Products. In a classic illustration of "time is money," Wyeth-Ayerst has made maximum use of the federal regulatory process to prevent -- or at least delay -- approval of a generic substitute for Premarin that could substantially reduce the cost of hormone therapy for women.

The stakes are enormous: The baby boomers are hitting menopause while evidence is increasing that estrogen replacement can help prevent heart disease and possibly Alzheimer's disease. A month's supply of .625 mg doses of Premarin costs $16.54 at the Giant pharmacy in McLean. The drug must be taken daily for the rest of a woman's life.

E. Thomas Arington is the president of Duramed Pharmaceuticals, a Cincinnati-based company that has spent $34 million to produce a plant-based generic substitute that he says would cost at least 30 percent less than the innovator drug. He says his company has done everything the Food and Drug Administration requires it to do to market the generic. But two years have gone by since his company faced what he thought would be the final hurdle, and he still hasn't gotten approval.

Wyeth-Ayerst has played Washington hardball, lining up support from women in Congress and women's organizations. The pitch to the FDA has been that the generics don't contain delta 8,9 dehydroestrone sulfate, an ingredient of Premarin that the FDA has repeatedly found to be an impurity and not a required component of any generic. The FDA's advisory committee reaffirmed that finding unanimously after two days of hearings in July 1995. The Drug Price Competition and Patent Term Restoration Action of 1984 requires that generics have the same active ingredients and that they act at the same rate, strength and concentration as the brand name.

Nevertheless, Wyeth-Ayerst, which holds the patent on delta 8,9, has been saying both in a citizens petition filed with the FDA and in its public relations campaign that it may be a key ingredient and that the FDA should require it to be included in any generic version. The FDA made public more research submitted to it by Wyeth-Ayerst last fall and opened up a 30-day period of public comment on the information, and that's where the matter stands. Meanwhile, Wyeth-Ayerst's vice president for regulatory affairs has told the Wall Street Journal that there is "probably nothing much" special about delta 8,9 and that it is "but one of many components in Premarin."

The FDA is feeling considerable heat: Sens. Barbara A Mikulski (D-Md.) and Patty Murray (D-Wash.) wrote the agency in the fall seeking, in Mikulski's words, "the FDA's assurance that it has no intention of approving a generic version of Premarin that lacks the `same' active ingredient as the innovator."

Women's organizations have also lined up behind Wyeth-Ayerst, and at least one of them, the Business and Professional Women/USA, acknowledged in FDA testimony that its foundation had received money from the company. Jane Tobler, a communications officer for the organization, which received $65,000 for its foundation, says BPW was particularly concerned after the 105th Congress arrived that drugs affecting women exclusively were getting ramrodded through the FDA approval process.

Arington says the opposition to the generic from women's groups has been "devastating." His company estimates that the generic would save female consumers $300 million a year and that the lower cost would make it affordable to tens of thousands of women who can't afford it now. "We've been hurt more by the influence of these groups than any other single thing." Moreover, he sees a threat to the whole generic drug industry if innovator companies are allowed to use the absence of impurities to block generics.

Approval for drugs should be based strictly on science -- not on politics, lobbying pressure or money. The FDA should not have to worry about encountering a political firestorm from women's organizations that may be beholden to corporate America for the handouts that keep many of them in business. Generics have enormous potential to save consumers money and to contain health costs. We should be encouraging companies to develop them and not enabling the innovator companies to use the regulatory process to maintain a monopoly.

© Copyright 1997 The Washington Post Company

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