Lucky Number 12? Biogenerics Legislation Trudges Forward

The biogenerics legislation that died in the last congress is slowly, painfully making its way through the current bunch of bureaucrats, as most folks expected it would when the Democrats took control.

The main issue raising everyone's hackles is exclusivity: how many years of protection should biotech drugs have before the generic makers get to piggy-back on their data and bring cheaper versions to market?

Here are the exclusivity options on the table: Congressman Henry Waxman (D-CA) and the Generic Pharmaceutical Association are angling for five years; the Obama Administration and the AARP recommend seven years; the Senate Health, Education, Labor and Pensions Committee voted for 12 years; Senator Ted Kennedy (D-MA) called for 13.5 years; and representatives Anna Eshoo (D-Calif.), Joe Barton (R-Texas) and Jay Inslee (D-Wash.) introduced a bill boasting 14 years.

As with everything else in politics, the debate is not without scandal. Slate reported that Senator Kennedy might have ulterior motives for his industry-friendly proposal, namely that Amgen Inc. has pledged $5 million to "help create the Edward M. Kennedy Institute for the United States Senate, a pricey 'Teddy Too' annex that Kennedy hopes to build alongside the John F. Kennedy Presidential Library and Museum."

Ironically, the Biotechnology Industry Organization, which is pushing for 12 to 14 years of exclusivity, took issue with Kennedy's proposal. According to a BioWorld Today article, BIO complained that Kennedy's measure actually provided just nine years of protection, and that some drugs could end up with zero if they are too similar to a previously approved product or get approved before the bill goes into effect.

For now, the Senate has settled on 12 years â€" good news for industry, but hardly the end of the debate because it will have to be joined with whatever bill emerges from the House, where Waxman is lying in wait.

Roulette photo by WikiMedia Commons user Uutela, GNU Free