Governors ask FDA to release guidelines on generic insulin and 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 have been informed that there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted,'' they wrote. 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. 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 Pfizer Inc. The FDA was careful to label Omnitrope, made by Novartis A.G.'s generics subsidiary Sandoz, a ``follow-on protein product'' and not a generic substitute for Genotropin. The agency added that the approval ``does not establish a pathway'' for other similar approvals. 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. "Source":[ http://www.siliconvalley.com/mld/siliconvalley/business/industries/biotech/15190130.htm]

---

Related articles

New Direction For Pancreas Cell Regeneration - Replacing faulty or missing cells with new insulin-making cells has been the object of diabetes research for the last decade (5.4.2007)