Waxman to Reintroduce Biologics Bill
1 CommentBy Ed Silverman // February 14th, 2007 // 8:26 am
He’s scheduled an 11:30 a.m. press briefing today. Joining him will be Chuck Schumer and Hillary Clinton, who will co-sponsor the bill authorizing generic biologics. But it will be slightly different than the bill he pushed last year.
Waxman’s new bill will allow innovator companies to take advantage of the abbreviated pathway as well to obtain approval of modified versions of their biologics, according to InsideHealthPolicy. Makers of biologics, such as insulin for diabetes and interferons for multiple sclerosis, often update treatments as more is understood about their products.
Industry tried to get Waxman to include a bump in data exclusivity from between four and five years to 10 years, which was the procedure in Europe. Companies would then be able to block generic copies for those years because generic firms couldn’t access to original data. This provision will not be included in Waxman’s reintroduction, according to the reportm citing sources who say a data exclusivity provision will be a negotiating point as the bill moves forward.
[tags]Biologics, Generics, Henry Waxman[/tags]
Melody
Could some informed reader please enlighten me? It is my understanding that insulin–whether we reference natural animal insulins or new rDNA insulin analogs–are not considered BIOLOGICS by the FDA. When I called FDA–Biologics, to obtain information about importing needed natural animal insulins, I was told that insulin is NOT considered a biologic.
Further investigation indicated that Lilly’s rDNA insulin “snuck” through FDA approval regulations using “medicine”–not biologics–guidelines. If this is indeed the case, maybe that is why the current crop of rDNA insulin analogs are so weak and problem-laden, and why “hypoglycemia unawareness” (a term long denied by pharma and medicine) has now become commonplace and addressed in scientific literature.