• Regulatory NewsRegulatory News

    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
  • Regulatory NewsRegulatory News

    Obamacare Repeal Bill Would Eliminate Tax on Device Companies

    Late Monday, the GOP unveiled its Obamacare replacement bill with at least one provision that medical device companies will like: a permanent repeal of the 2.3% medical device tax. The tax’s full repeal, which was floated in standalone legislation in early January, would begin 1 January 2018 under the new version of Obamacare, known as the American Health Care Act (AHCA). That full repeal would also come more than two years after the tax was suspended following a ...
  • Regulatory NewsRegulatory News

    Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway

    Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away. “I can imagine this provision will be carved out, if you will…part of the problem with the ACA [ Affordable Care Act ] is that it became so big that it was hard to totally ...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...
  • Republicans Ramp up Pressure on White House Over PPACA Negotiations

    • 16 May 2012
    Republican members of the House Energy and Commerce (E&C) Committee announced in a 16 May statement they have obtained new information regarding the role of the White House in the 2009-10 negotiations with the pharmaceutical industry over provisions in the Patient Protection and Affordable Care Act (PPACA) . The negotiations, which were done quietly to avoid media and political scrutiny, "were never made public," explained Republicans members of the E&C Committ...
  • Deadline for Mandatory Submission of Drug Sample Information to FDA Closes Soon

    The US Food and Drug Administration (FDA) released updates this week (26 March) on submitting information required under the Patient Protection and Affordable Care Act (PPACA) . Under the law, pharmaceutical companies are required to submit certain drug sample information to FDA before 1 April 2012 and every year thereafter. Under the PPACA's Section 6004, " Prescription Drug Sample Transparency ," manufacturers must submit: the identity and quantity of drug samples...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act: Day Three

    • 28 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) Medicaid expansion provisions and whether the 'individual mandate' is severable from the PPACA . In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of what you need to know about the case, the court, the hearings, the arguments and more. Medicaid: NPR - Supreme Court's Med...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) 'individual mandate' provisions. In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of the essentials of what you need to know about the case, the court, the hearings and more. The Individual Mandate: Reuters - Supreme Court moves to heart of healthcare case The New York...
  • What You Need To Know About Today's Supreme Court Hearing on the Affordable Care Act

    • 26 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear three days of arguments on the Patient Protection and Affordable Care Act (PPACA) starting Monday, 26 March. In preparation for those arguments, Regulatory Focus has assembled a list of everything you need to know about the case, the court, the hearings and more. Case Summary: Washington Post Wonkblog - SCOTUS 101: A Wonkblog guide to health care oral arguments Kaiser Health News - The Health...
  • Survey: FDA 510(k) Submissions Garner Most Concern Among Device Professionals

    A new survey of medical device professionals conducted by the publication Medical Device and Diagnostic Industry found that 510(k) submissions garner the most concern among all regulatory issues, followed closely by the pre-submission process to the US Food and Drug Administration (FDA). The survey of 283 medical device professionals asked what two regulations and regulatory processes were of the most concern. Thirty-six percent of respondents indicated 510(k) submi...