Generics Fail to Win FDA Approval as Replacements for Estrogen Drug

WASHINGTON — The government rejected generic versions of the estrogen replacement Premarin--the nation’s most widely prescribed medicine--saying they fail to exactly replicate the brand product.

“For something to be generic, it has to be absolutely identical and deliver the same active ingredients as the original product,” Don McLearn, a Food and Drug Administration spokesman, said Monday.

Premarin treats women with menopausal symptoms; can help prevent osteoporosis, a condition that reduces bone density; and may be effective in fighting heart disease and warding off Alzheimer’s disease.

Last year, the drug reaped manufacturer Wyeth-Ayerst Laboratories $860 million in sales, with an estimated 8 million women a year taking the tablets.

“We’re certainly gratified that the FDA has recognized that the science here is extremely important,” said Marc Deitch, senior vice president at Wyeth-Ayerst.

But makers of generic forms of Premarin contended Monday that heavy lobbying by women’s groups and scientists on behalf of Wyeth-Ayerst had influenced the FDA’s decision.

“I think this is a case of politics over science,” said Bruce Downey, president of Pomona, N.Y.-based Barr Laboratories. Barr and Cincinnati-based Duramed Pharmaceuticals are seeking approval for their generic forms of Premarin.