In their petition, the governors wrote that documents outlining what the FDA expected of drug makers before generic versions of the two drugs could be approved had existed since at least 2002, and that "there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted."
In March, the FDA refused to issue guidelines specific to generic versions of the two drugs, opting instead to develop guidelines pertaining to generic biotech drugs -- drugs based on proteins from living cells, also known as biopharmaceuticals or biologics.
The governors said in their letter that HGH and insulin are different from biologics, and should not be lumped in with other biotech drugs. They added that both have relatively simple structures and have a long history of safe usage.
FDA spokeswoman Susan Bro disagreed that the case was not that simple. "These products raise complicated scientific issues and we continue to work on them internally," she said. "FDA will review the governors' concerns carefully and respond accordingly."
While the FDA approved Novartis A.G.'s Omnitrope -- a generic version of the growth hormone Genotropin, made by Pfizer Inc. -- in May, they were careful to label the knockoff a "follow-on protein product" rather than an actual substitute for Genotropin, and added that it "does not establish a pathway" for future approvals of similar products.
"This delaying tactic is yet another way the FDA protects the financial interests of Big Pharma," explained Mike Adams, an outspoken critic of the FDA. "Generic drugs reduce the profits of the industry's most powerful drug companies, and each day the FDA delays the introduction of generics to the market, Big Pharma earns millions more in profits," he said. "The FDA is engaged in widespread antitrust activities designed to protect the prescription drug monopoly market in the United States."
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