Biotechnology Healthcare - November/December 2008 - (Page 30) “And so, ‘generic’ may not even be the appropriate term for a product.” The third — and a particularly contentious — issue, though, is data exclusivity. This refers to the length of time during which a competitor cannot rely on the FDA’s prior finding of safety and effectiveness of an innovator product if seeking approval of its similar product. Biotechs favor a lengthier period and were ecstatic when Democratic Congresswoman Anna Eshoo, of California — where many biotechs and venture capitalists are based — introduced a bill that offers brandname products 12 years of exclusivity, plus an extra two years for a medically significant innovation. According to one Congressional source, there is substantial support for offering extra incentives for additional indications. THE BIGGEST HANGUP For generic drugmakers, the core issue is the extent to which they would be prevented from developing their own versions of biologics. Not surprisingly, the Generic Pharmaceutical Association, which prefers only a few years of data exclusivity, labeled the length of time in the Eshoo bill “unjustifiable,” and argued that it would be “decades” before consumers would see affordable biologics. Their big concern is that patents will be wielded as an instrument in the same way that loopholes in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the HatchWaxman Act, were exploited to delay generic versions of brandname drugs. In fact, the Federal Trade Commission is examining the issue with an eye toward sorting out competition, incentives, and patents. The FTC, of course, has been laboring to derail so-called “pay-to-play” between brand-name drugmakers and generic rivals. So the agency is holding workshops to figure out ways “to strike the right balance between regulatory exclusivity periods and competition to spur development” of follow-on biologics. “There’s no question that the biggest hang up is over intellectual property rights and data exclusivity,” says Duke’s Grabowski. “The branded industry wants fairly long data exclusivity, while generic manufacturers are pushing for something similar to Hatch-Waxman — maybe five years. The thinking may be that, if they wait long enough, the political winds will shift and they may get a bill more to their liking. And I think it is possible you’ll get a Congress that’s more sympathetic to biogenerics. “Although, some Democrats have innovative biotechs in their districts that want a bill that preserves innovation. Look at California and Massachusetts, “ he continues. “To be honest, I think there may be a little shortsightedness here. You need a healthy innova- tive industry to have a generic industry. But again, this will all take time. Remember, the FDA tends to move slowly, it’s understaffed and, more recently, it’s being very cautious about safety. And so I think the agency will need to carefully follow guidelines and I think they will go case by case.” One FDA official declined to be specific about particulars. But Rachel Behrman, the agency’s associate commissioner for clinical programs, cautions that the FDA is, indeed, attempting to move very deliberately as it weighs the proper course to pursue. And for that reason, she suggests the large cost savings that are projected should be considered as just that — nothing more than estimates. “Remember that many of the projections have been based on the generic drug model, which includes switching” between drugs, she says. “But it’s not likely, scientifically speaking, to be the model that might happen.” Ed Silverman is a writer at the StarLedger, in Newark, N.J., and is the blogger behind Pharmalot.com. It didn’t matter who won the election B oth Sens. John McCain and Barack Obama have favored the creation of a regulatory pathway for follow-on biologics, but during the presidential campaign, neither offered details of a plan to achieve that end. The only hint of a direction that Presidentelect Obama may support can be gleaned from a June 27, 2007, voice vote by the Senate Committee on Health, Education, Labor, and Pensions approving the Biologics Price Competition and Innovation Act. Obama was a member of the committee. A Lehman Brothers strategic analysis, officially issued Sept. 15, 2008 — ironically, the same day the securities firm declared bankruptcy — predicted that congressional action on follow-on biologics would be part of a larger effort by Democratic leaders to reform healthcare in general in 2009. Lehman predicted that passage of a regulatory pathway would occur by 2010. 30 BIOTECHNOLOGY HEALTHCARE · NOVEMBER/DECEMBER 2008 http://www.Pharmalot.com
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