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  • Regulatory NewsRegulatory News

    AAM: Medicare Part D plans slow to adopt generics

    Medicare Part D plans are slow to adopt generic medications for their beneficiaries, according to a recent report released by the Association for Accessible Medicines (AAM).   For the 2021 plan year, Medicare Part D formularies covered 21% of approved first generic medications from the previous year compared with the 66% covered by commercial formulary plans, the report stated. But this is part of a years-long trend, according to AAM. Not only do Medicare Part D plans ...
  • Regulatory NewsRegulatory News

    What’s behind drug price spikes – and what can be done?

    Two newly published studies have highlighted the rising cost of brand-name and generic drugs, looking at why generic price spikes happen and how drug price hikes affect insured patients.   In an analysis published in Health Affairs , Aayan N. Patel, a researcher with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital in Boston, and colleagues said that although there have been fewer spikes in drug prices be...
  • Feature ArticlesFeature Articles

    Starting out: A beginner’s toolkit of US regulatory resources

    This article offers a selection of 28 publicly available resources for newcomers to the regulatory profession. The author recommends many US Food and Drug Administration (FDA) websites, including information and guideline resources from a number of the agency’s centers and their respective websites and searchable databases.   Introduction The FDA website is the go-to platform for US-related regulatory information ( Table 1 [1]). This multipurpose learning and resea...
  • Regulatory NewsRegulatory News

    Trump: Drug Importation Coming Soon

    In remarks related to an executive order on Medicare, President Donald Trump on Thursday gave a speech filled with falsehoods about the Right-to-Try law, claims that drugmakers would lower their prices once importation begins and a suggestion that the pharmaceutical industry is aiding his impeachment. Trump also read from the teleprompter to explain a proposal that’s coming soon to lower drug prices by importing drugs from Canada and other countries. First revealed in ...
  • Regulatory NewsRegulatory News

    US Intervenes in False Claims Suit Against Alere, Arriva Medical

    The US Department of Justice (DOJ) announced Tuesday that federal prosecutors intervened in a lawsuit under the False Claims Act whistleblower provisions against a former supplier of blood glucose monitoring supplies. The case alleges that Arriva Medical and its parent company Alere “submitted or caused false claims to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment w...
  • Regulatory NewsRegulatory News

    Democrats, Republicans Unveil Drug Pricing Bills

    As a new Congressional term kicks off, Democrats and Republicans in Congress, as well as the Trump administration, are pushing policies to lower prescription drug prices.   On Wednesday, Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) introduced a bill, dubbed the Safe and Affordable Drugs from Canada Act of 2019, that would allow for Americans to import drugs from Canada. The bill mirrors the bill by the same name championed by the late Sen. John McCain (R-AZ...
  • Regulatory NewsRegulatory News

    House E&C Offers Recommendations to Improve 340B Drug Pricing Program

    The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...
  • Regulatory NewsRegulatory News

    Not Just Mylan: Misclassifications May Have Cost Medicaid More Than $1B

    The US Department of Health and Human Services' (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the Department of Justice from August in which the drugmaker agreed to pay $465 million to settle claims relating to the misclassification ...
  • Regulatory NewsRegulatory News

    Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

    Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...
  • Regulatory NewsRegulatory News

    CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect

    The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term. And though the predictions are largely hypothetical (since there are not currently multiple biosimilars for any reference biologic on the mar...
  • Regulatory NewsRegulatory News

    Sen. Warren: Adding UDIs to Medicare Claims Forms Should be a 'No-Brainer'

    Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data. At a hearing Tuesday at the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Elizabeth Warren (D-MA) called on CMS to update the Medicare claims form to include a line for the unique device identifier (UDI) to kno...
  • Regulatory NewsRegulatory News

    Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot

    US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications. FDA  launched the pre-cert pilot  in July as part of the agency’s  Digital Health Innovation Action Plan. The pilot participants, representing a range of companies and technology in the ...