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McClellan's Balancing Act: Yes to Generics, No to Imports & Price Controls

Executive Summary

It's hard to fault the FDA commissioner for his even-handed treatment of the two drug industries--branded vs. generic--and the competing social imperatives they stand for: new drug research and affordability. In recent speeches, Mark McClellan, MD, PhD, has been making the branded industry's case both for higher drug reimbursement from Europe and against parallel imports from Canada. And he's also been pushing for making it easier for branded generic drugs to hit the market. The only problem with this balancing act: he has far more power to quickly advance the generic agenda than the branded one.

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FDA Faces Mounting Pressure on Shortcut Approval Pathway

The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act-505(b)(2)-which allows companies to rely on data other than their own to attain drug approval.

Transatlantic Tit For Tat

Echoing other transatlantic rifts, FDA commissioner Mark McClellan argues that America, with its unrestricted drug pricing, is paying Europe's drug R&D bill. Pharma companies agree. European authorities-the only faction with the power to alter pricing policies-don't. But the public disagreement hasn't prevented closer cooperation between the FDA and the EMEA. The agencies' recently announced confidentiality agreement paves the way for better information sharing and could simplify the complex European regulatory arena. But it won't necessarily speed approvals-some drug firms argue that it may even slow them down.

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