February 14, 2006

Two prominent lawmakers have urged the FDA to issue the guidance documents it has already drafted for follow-on insulin and human growth hormone (HGH) products.

"It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product," Rep. Henry Waxman (D-Calif.) and Sen. Orrin Hatch (R-Utah) write in a recent etter to acting FDA Commissioner Andrew von Eschenbach.

"There simply is no excuse -- scientific, legal, or otherwise -- for FDA to continue to delay the release of these guidance documents," the letter noted. The FDA drafted the documents in 2002, according to the letter.

The request comes just a few weeks after a European Medicines Agency advisory committee recommended approval for Sandoz's HGH candidate Omnitrope (somatropin recombinant).

The lawmakers acknowledged the FDA may need additional time to develop an approval pathway for more complicated biologics regulated under the Public Health Service (PHS) Act, but said "the legal framework already exists" for insulin and HGH.

"Insulin and HGH are two products that should be separated from a larger regulatory framework because they do not have the same scientific and regulatory issues as biological products," the letter said. "They have relatively simple structures with a long history of safe use by millions of people."

Moreover, because both of these products are regulated under the Federal Food, Drug and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with the approval of generic forms of products regulated under the PHS Act, they added.

The lawmakers have urged the FDA several times to set up a regulatory path for generic biologics, which they said could help control spiraling healthcare costs and would create competition for firms that essentially have a monopoly on the products.