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  • 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

    Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit

    The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead. The proposal would limit what level of expenses will qualify and limit qualified clinical expenses if they are related to the use of a drug which has previously been approved for diseases or conditions affecting more than 200,000 persons in the US. The tax credit is part of a law from...
  • 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...
  • Regulatory NewsRegulatory News

    Senate Committee Advances FDA User Fee Reauthorization Bill

    The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...
  • 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...
  • Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

    • 23 April 2012
    Former US Food and Drug Administration (FDA) Commissioner Mark McClellan, now a member of the think tank The Brookings Institute, penned an opinion piece in The Hill in which he argues FDA must take advantage of a "paradigm shift" in our understanding of specific pathways of disease to get treatments to patients faster. "Our progress in understanding the specific pathways of disease has identified hundreds of new targets for potentially life-saving drugs that hold ...
  • Senators Draft Bill to Expedite Drug Approval

    A piece of legislation introduced this week by a bipartisan group of three Senators would "expedite US Food and Drug Administration (FDA) approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy," according to the Senators. Sens. Michael Bennet (D-CO), Richard Burr (R-NC) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Therapies for Patients Act (ABTPA) on ...