• Regulatory NewsRegulatory News

    FDA seeks input on pre-Hatch-Waxman ‘PANDA’ applications

    The US Food and Drug Administration (FDA) on Thursday asked for input from stakeholders on how it should handle certain drugs approved in abbreviated applications before the enactment of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendments) in 1984, which created the agency’s modern regulatory framework for generic drugs.   In a Federal Register notice announcing the consultation, FDA refers to such products as “pre-Hatch-Waxman abbre...
  • Regulatory NewsRegulatory News

    Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance

    The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984 . But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views. In July, FDA held a meeting to discuss certain situations in ...
  • Regulatory NewsRegulatory News

    Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

    Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused. Like others, California Attorney General Xavier Becerra submitted comments calling for pay-for-delay agreement reforms, including legislation to make the deals "presumptively unlawful," reforms to FDA’s citizen petition process a...
  • Feature ArticlesFeature Articles

    What’s In a Name? The Value of Pharmaceutical & Biologic Branding

    September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch-Waxman strove to offer consumers the benefits of “rapid availability of lower-priced generic versions of innovator drugs” 1 while preserving a meaningful period of market exclusivity for innovators to recoup their costs. In the process, however, Hatch-Waxman established conditions that fundamental...
  • Senator Looks to Spur Development of Medicines Through 'Prize Fund'

    • 15 May 2012
    A Senate hearing being held by Senator Bernie Sanders (I-VT) seeks to advance legislation that would create a prize fund for companies to create new medicines and vaccines, partially replacing the current market-exclusivity model of product development. Sanders' legislation, S.1137: The Medical Innovation Prize Fund Act , was introduced in May 2011, but has thus far eluded much notice. In remarks on the Senate floor on 15 May, Sanders said he did not expect the bill...