Monday, May 14, 2007

But what’s in it for me? Antibiotic incentives in FDARA

It’s not all bad news for drug developers. The Senate’s drug safety legislation emerged from that chamber on May 8th carrying some interesting drug development incentives tucked away among the added requirements for postmarket surveillance and marketing/communication controls.

We watch C-SPAN, so you don’t have to

The two most interesting incentives—which promise limited scope for faster drug reviews and longer product lives—both relate to anti-infective drug development.

The first incentive, suggested as an amendment by the odd pair of very liberal Ohio Democrat Sherrod Brown and very conservative Kansas Republican Sam Brownback, would offer a faster FDA review for any drugs of a sponsor’s choice (anything in a sponsor’s pipeline—not just anti-infectives). All a sponsor would have to do to get access to the faster review would be to develop and make commercially available a product for under-treated diseases prevalent in the developing world.

The second amendment, sponsored by Utah Republican Orrin Hatch, claims to expand research incentives for antibiotics and redress exclusivity issues created ten years ago in a previous Congressional effort to bring antibiotics under Waxman-Hatch exclusivity provisions.

The first measure, Brown said, would be built on awarding “a priority review voucher to any company that brings a neglected tropical disease treatment to market.” It derives from an early 2006 proposal from a group at the Duke Fuqua School of Business, “Developing Drugs for Developing Countries,” and proponents say it could be worth about 12 months of extra marketing time to a company: FDA is supposed to conduct priority reviews within six months compared to “the average time of 18 months” for standard FDA application reviews. What’s more, research-stage companies that earn such vouchers could sell them on to Big Pharma, creating an additional asset market that encourages investment in neglected diseases.

Skeptics argue that tying the vouchers to “priority” review—instead of patent life or market exclusivity--may not turn out to be a big incentive. A senior Merck policy executive, Ian Spatz, openly questioned the vouchers’ value shortly after the Duke proposal was published. The difference in approval times associated with standard and priority reviews is much shorter than a year, argues Spatz, and therefore much less valuable to big commercial sponsors. And major products, where a voucher might tend to be used, often qualify for priority review in their own right.

The Hatch antibiotic incentive amendment would confer five-year market exclusivity for antibiotics filed with FDA before November 1997 but not yet approved by the agency. Preliminary analysis of the provision also suggests that it would permit generic copies of some antibiotics approved before November 1997 and so-far protected from generic competition due to an obligation for the follow-on sponsor to show that all patented indications have expired.

Hatch is also calling for clearer orphan drug incentives for anti-infectives. The amendment calls for FDA to hold an open meeting to clear up what indications qualify for orphan protections, including market exclusivity. Currently, anti-infective sponsors—and even some FDA reviewers—do not know how indications are counted toward the orphan population limits. The open meeting is designed to make it clear whether a product can qualify for orphan incentives if it treats a subclass of an infection (such as pneumonia) caused by a specific pathogen.

The Hatch incentives also would offer exclusivity protections to new approvals for single enantiomer drugs with an enantiomer that was previously part of an approved racemic drug, if the enantiomer drug is in a different therapeutic class. That distinction would prevent evergreening of existing products in the same class as an existing product (we’re looking at you, Nexium) but offer an incentive for the development of enantiomer in a new therapeutic category.

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