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  • 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...
  • 2.3% Tax on Medical Device Companies to Take Effect in 2018

    As some companies cheer new tax cuts, medical device companies will ring in the new year with the reinstatement of a 2.3% tax put in place by the  Affordable Care Act , after efforts to permanently repeal or delay the tax failed. Scott Whitaker, president and CEO of the device industry group AdvaMed, sent a letter to President Donald Trump on Wednesday, highlighting Congress’ failure “to address a punitive tax that singles out the American medical technology ind...
  • 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 ...
  • Republicans Dig Into FDA for Helping to Promote Obamacare Law

    If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of something that has almost nothing to do with food, drug, medical devices or other regulated products. Background That thing, as it turns out, is the Patient Protection and Affordable Care Act (PPACA) - "Obamacare," if you like - President Barack Obama's signature health care over...
  • Orphan Drug Manufacturers Would be Exempt from 'Obamacare' Fees Under New Bill

    A new piece of legislation introduced this week by Rep. Jim Gerlach (R-PA) would clarify that developers of orphan pharmaceutical products are exempted from an annual fee otherwise levied on manufacturers to help fund the government's expansion of national healthcare. Background Orphan drug products have long been exempted from a range of fees otherwise levied on other manufacturers. As defined under the Orphan Drug Act of 1983, orphan drugs are those intended to trea...
  • Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off

    • 29 November 2012
    Signs are emerging that a long-awaited landmark regulation governing the transparency of gifts given to medical practitioners by industry has entered its last clearance stage before final promulgation. The rule, Transparency Reports and Reporting of Physician Ownership of Investment Interests , is the direct result of the Patient Protection and Affordable Care Act (PPACA) -colloquially known as Obamacare-the seventh title of which contains the "Physicians Payment Suns...
  • PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • 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...
  • Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway

    • 13 April 2012
    The Pharmaceutical Research and Manufacturers of America was an early-and controversial - supporter of the Patient Protection and Affordable Care Act (PPACA) when the legislation was being formulated. Now under the tutelage of President John Castellani, the group says it is looking to keep the legislation in place, reports Market Watch . The loss of a regulatory pathway for approving biosimilar products, said Castellani, would be a disastrous setback. Likewise a num...