Contributions taint FDA independence

Insight on the News, Sept 8, 1997 by John Berlau

Under the Drug Price Competition and Patent Term Restoration Act of 1984, manufacturers can market generic versions of brand-name drugs after patents expire without doing studies for safety and effectiveness if they can show the FDA that the generics contain the same "active ingredients" -- the ingredients that contribute to the drug's safety and effectiveness -- in the same composition and potency as the original drug. Since 1970, the FDA had held that Premarin contained only two active ingredients, both of which were in the generic versions.

According to an FDA statement, generics could not be approved "because the active ingredients in Premarin have not yet been adequately defined." The statement explained that Premarin was approved in 1942, long before the FDA required such comprehensive knowledge of how a drug works. The FDA suggested that the only way a generic Premarin could be approved would be if it were the same source material -- horse urine.

But Duramed Pharmaceuticals President Thomas Arington, whose company's generic alternative is plant-based, says, "There's no reason to use 1940s technology on a 1990s product."

The FDN's own scientists appeared to favor approval of the generics. Two days before the decision, the agency's Office of Pharmaceutical Science issued a memorandum recommending that the FDA keep its requirement of only two active ingredients for generic conjugated estrogens and warning that "certain possible FDA decisions in this matter may have the effect of ... impeding generic substitution." CAGW's Paige says that the FDA's decision was "very clearly subverted to a political agenda."

Documents obtained by Insight lend additional credence to claims of Paige and other critics that politics, not science, was the driving force -- particularly regarding the influence of one Clinton appointee, FDA Associate Commissioner for Legislative Affairs Diane Thompson. Thompson previously had worked for Foreman & Heidepriem, the feminist lobbying firm AHP employed on this issue, and as chief of staff for Democratic Sen. Barbara Mikulski of Maryland, who wrote to oppose approving generics and who received $1,000 contributions in 1995 from three members of the Foreman & Heidepriem firm. Observers say that Thompson, Mikulski and the lobbyists operated as an "oldgirls' network," and a former FDA official called Thompson "the only political appointee I've seen who acted like she worked for somebody else." Neither Thompson nor Mikulski would respond for the record.

Insight obtained letters by opponents of generic Premarin addressed directly to Thompson. An E-mail written by Thompson at the time suggests she injected herself into the scientific process in a way that supported AHR According to a memorandum of the inspector general of the Department of Health an Human Services, Thompson convened an unusual meeting in March 1995 in which participants reached a consensus that even though an FDA scientist "did not think the Wyeth-Ayerst argument ... had scientific merit," further "review of this issue ... made sense because it had become a `public-policy issue.'"