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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...
  • Regulatory NewsRegulatory News

    Markey and Warren Re-Intro Bill to Repeal Medical Device Tax

    Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year. The re-introduction of the bill, originally included in the Affordable Care Act (aka Obamacare), highlights how many device companies are in Massachusetts. And similar to the 2015 legislation, the Massachusetts Democrats are looking to pay fo...
  • 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

    Updated: House and Senate Pass Tax Overhaul

    The US House of Representatives and the Senate on Wednesday passed the GOP tax overhaul bill. President Donald Trump indicated he will sign the bill into a law. Bill Details Members of the House-Senate Conference Committee on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half . The cut would reduce the credits claimed by companies by $32.5 billion from 2018 to 2027, according t...
  • Regulatory NewsRegulatory News

    Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill

    Members of the House-Senate Conference Committee discussing the GOP's tax overhaul plan on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half. Currently, companies can claim a 50% tax credit for qualified clinical testing expenses incurred in testing certain drugs for rare diseases or conditions, generally referred to as "orphan drugs," affecting fewer than 200,000 persons in th...
  • Regulatory NewsRegulatory News

    Congress Looks to Delay Medical Device Tax by 5 Years

    The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018. The 2.3% tax, which was put in place by the Affordable Care Act but then delayed through the end of 2017, would be delayed another five years under the GOP bill . Industry group AdvaMed commended the leadership of House Ways & Means Committee Chairman Kevin Brady (R-TX) and Reps. Erik Paulsen (R-MN) and Jackie Walorski (R...
  • Regulatory NewsRegulatory News

    Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included

    The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it. The House-passed bill includes several provisions that would be attractive to the biopharma industry, though industry groups BIO and the National Organization of Rare Disorders took issue with a provision to repeal the orphan drug tax credit, which amounts to half of all qualified ...
  • 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

    GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits

    Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern. Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products. Background Under the  Orphan Drug Act  of 1983, Congress sought to incentivize the d...
  • Regulatory NewsRegulatory News

    White House Doubles Down on Call to Fund FDA Entirely With Industry Fees

    Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," the White House said in a statement . "In an era of renewed fiscal restraint,...
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    Senate Health Bill Would Repeal Device Tax

    Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law. The bill, referred to as the Better Care Reconciliation Act , proposes to rework the Affordable Care Act by eliminating the individual insurance mandate, phasing out Medicaid expansion beginning in 2021 and capping Medicaid spending. Whil...
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    AdvaMed CEO Confident of Device Tax Repeal This Year

    The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year. Whitaker made the remarks during a call with reporters on Tuesday, where he also discussed potential changes to the US Food and Drug Administration's (FDA) inspection program for devices. Device Tax Repeal Despite the stalling of the Obamacare replacement b...