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Abstract
The architect of the generic pathway law is proposing tweaks to his signature legislation that include eliminating certain exclusivity protections, reducing or eliminating patent extensions and even rethinking whether exclusivity should be based on a set timeframe, according to a new report authored by former Rep. Henry Waxman (D-CA) and former Deputy HHS Secretary Bill Corr. Waxman also suggests a number of ideas sure to inflame brand pharma, including allowing reimportation even when a drug is protected under patent or marketing exclusivity, and using the threat of march-in-rights to set prices for government-developed drugs. Waxman suggests "expand[ing] FDA authority, notwithstanding patent or market-exclusivity protection, to permit importation or reimportation when a drug becomes inaccessible due to its high price or short supply and is available at a lower cost in another country." "Require a manufacturer awarded the three-year New Clinical Investigation Exclusivity incentive to demonstrate significant clinical benefit over existing therapies manufactured by the applicant in the five-year period preceding submission of the application," Waxman suggests. Allan Coukell, senior director of health programs at The Pew Charitable Trusts, commended the effort and suggested changes to the law's exclusivity provisions are warranted. The FDA is making strides to improve the efficiency of the generic drug review process, and additional resources are needed to enhance access to [high quality], lower-cost generics," the report states. The report also suggests requiring FDA to report the backlog of generic drug applications and requiring the FTC and Department of Justice "to regularly review markets and any...
