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  • 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...
  • Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

    • 18 October 2012
    • By
    Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals. The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the am...
  • Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

    What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy. The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus fa...
  • Senator Looks to Spur Development of Medicines Through 'Prize Fund'

    • 15 May 2012
    • By
    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...
  • GSK's Witty: UK Delaying New Cancer Drugs Due to Cost

    Andrew Witty, the chief executive of pharmaceutical manufacturer GlakoSmithKline, said in an interview with the BBC on 25 February he believes the UK's National Institute for Health and Clinical Excellence (NICE) is purposefully delaying new drugs in order to save the government money . It's bad enough that reimbursement amounts are being systematically reduced across Europe, said Witty, "[but] governments are now delaying the approval of innovative new drugs." Witty...
  • Reps. Waxman, Rush Introduce Bill to Stop 'Pay-For-Delay' Settlements

    • 13 February 2012
    • By
    A bill introduced by Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) on 9 February would end so-called "pay-for-delay" settlements used by pharmaceutical companies to delay competition from generic competitors. The bill, Protecting Consumer Access to Generic Drugs Act of 2012 (H.R. 3995) , declares it "unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which (1) an [Abbreviated ...
  • Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

    Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the authority to prevent medical devices from claiming substantial equivalence to a recalled medical device. Carney's bill, the Drug Shortage Prevention Act of 2012 , would amend Chapter V of the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to require FDA to establi...