Pharma defeats biotech push for rapid approval program

Biotechs butted heads with their far-larger pharmaceutical allies over a key lobbying issue, and lost. As Bloomberg reports, biotechnology companies threw their weight behind a plan drafted by North Carolina Democratic Sen. Kay Hagan to launch a more rapid FDA approval program, using fewer human trials, for orphan drugs or treatments that address fatal diseases. Pharmaceutical companies beat back the measure, however, apparently not wanting to dilute existing safety measures.

In a word: awkward. Both industry sectors lobby as part of the Biotechnology Industry Organization, a group that theoretically represents both sides' interests equally as drug development increasingly overlaps between each side. BIO board members representing the far smaller biotechs supported the proposal, but their pharmaceutical industry counterparts nixed the idea, Acorda Therapeutics ($ACOR) CEO Ron Cohen told Bloomberg. (His company, of course, is a biotech.)

Biotechs want the plan because they'd gain a more rapid approval timeline by redefining what efficacy means, using things like biomarkers that measure a drug's potential effectiveness, early trial results, or interim data to support regulatory approval. The idea arguably reflected a more innovative approach typical for biotechs, but they are also still relatively small and not generating significant revenue, so they'd welcome anything that could help better manage the financially punishing cost of traditional, extensive clinical trials. On the other hand, larger pharmaceutical companies want to preserve the existing system, citing safety concerns, but the status quo also helps preserve an important financial stake. Pharmas often help fund biotech clinical trials and then share the revenue once a drug hits the market, University of Michigan business professor Erik Gordon noted to Bloomberg.

A GlaxoSmithKline ($GSK) spokeswoman told Bloomberg that her company (one of the Big Pharma BIO members) preferred changes to existing programs with which regulators and regulated companies already work. Along those lines, BIO, perhaps not surprisingly, is pushing a compromise plan that would add other orphan drug or fatal disease-treatments to an existing program that accelerates approval for both cancer and HIV drugs, BIO CEO Jim Greenwood said in the story. Hagan will submit the new proposal to Congress later this year, Greenwood said, and it may be folded into larger legislation that renews the drug industry fee system that funds FDA regulatory reviews.

The compromise throws biotechs another bone: the use of surrogate endpoints, which show how a drug affects biological activity. But regulators would still require companies to prove clinical outcomes at some point.

- here's the Bloomberg story

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