Governors Seek Guidelines for Generic Biotech Drugs
The governors of Kansas, Minnesota, Vermont and Wisconsin on Thursday petitioned FDA to issue "long-delayed" guidelines for approval of generic versions of human growth hormone and insulin, two biotechnology medications, the AP/Washington Post reports.
According to the petition, such guidelines have existed in draft form since 2002, and FDA has "no scientific reasons" to delay their issuance. The petition states the guidelines would increase competition and would reduce by hundreds of millions of dollars from the almost $2 billion spent annually on brand-name versions of HGH and insulin.
In addition, the petition states that FDA should consider HGH and insulin separately from other biotech medications because the two medications have relatively simple structures and a history of safety (Bridges, AP/Washington Post, 8/3).
FDA spokesperson Susan Bro said, "These products raise complicated scientific issues, and we continue to work on them internally." Bro said that FDA will "review the governors' concerns carefully and respond accordingly" (Henderson, Boston Globe, 8/4).