Governors ask FDA to release guidelines on generic drugs
WASHINGTON --Vermont Gov. Jim Douglas and his counterparts in three others states petitioned federal health officials Thursday to issue long-delayed guidelines on the production of generic versions of insulin and human growth hormone.
The documents would help spur competition and eventually drive down prices, shaving hundreds of millions of dollars from the nearly $2 billion spent on the two biotechnology drugs each year, the governors of Kansas, Minnesota, Vermont and Wisconsin wrote in petitioning the Food and Drug Administration.
The documents would spell out what the FDA expects of generic pharmaceutical companies before it could consider approving their copycat versions of the two drugs. The documents have existed in draft form since at least 2002, the governors said.
"We're tired of waiting for the FDA to act," said Douglas, speaking at a news conference in Montpelier, Vt. "It's time for the federal government to end its footdragging and put the interests of Americans who need access to less expensive medications ahead of the interests of the pharmaceutical industry."
Douglas and the others said there were no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted.
In March, however, the FDA told lawmakers that it would not issue documents specific to the two drugs. Instead, it said that guidelines relevant to generic biotech drugs in general would be "more appropriate." An FDA spokeswoman did not immediately return a call seeking comment Thursday.
"Many Vermonters are finding it increasingly difficult to afford prescription drugs," said Douglas, a Republican. "We owe these individuals the best medicine science can provide at the most affordable price."
Unlike chemical drugs, biotech drugs -- also called biopharmaceuticals or biologics -- are based on proteins derived from living cells.
The governors said that insulin and human growth hormone are a breed apart and should be considered distinct from other biotech drugs. Insulin for diabetics and human growth hormone, used to treat growth deficiencies and other conditions, both have relatively simple structures and a long history of safe use, they said.
In May, the FDA approved a knockoff of the growth hormone Genotropin, made by
The Generic Pharmaceutical Association said at the time that the action was a first step to opening the industry to competition from generics. But FDA guidelines are still needed to help expedite the process, the governors said.
The Biotechnology Industry Organization maintains that copycat versions of biotech drugs should undergo lengthy human trials to prove they're safe and effective.
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Associated Press writer John Curran in Montpelier, Vt., contributed to this story.
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