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    ‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs

    A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs. The “Fair Access for Safe and Timely Generics Act of 2017,” or “FAST Generics Act of 2017,” introduced by Reps. David McKinley (R-WV) and Peter Welch (D-VT) would amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible generic and biosimilar developers have competitive acce...
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    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 ...
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    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
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    Maryland Goes a Step Further to Rein in Drug Price Spikes

    A Maryland bill to shine more light on prescription drug prices takes the standard for state transparency efforts a step further by not only requiring pharmaceutical companies to offer a peek into their innerworkings but requires annual reports to be audited by third parties. The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs as ot...
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    Industry Group Links More Than 28,000 Job Losses to Device Tax

    As part of its push to fully repeal the medical device tax from the Affordable Care Act , industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect. Citing data from the Commerce Department, AdvaMed notes that from 2012 to 2015, the number of medical technology jobs in the US declined from 401,472 to 372,638, and though the group does not explicitly say the job loss...
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    Bipartisan House Bill Seeks to Repeal Medical Device Tax

    Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA). While the ACA is likely to be repealed and possibly replaced in full by the 115th Congress, this bill ( HR 184 ) would make permanent a delay that kept the tax from taking effect through next year. President-elect Donald Trump also has said he supports ...
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    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 ...
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    A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

    With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes. Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Spe...
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    Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge

    Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The boost in funds for FDA and NIH, backed by the Health, Education, Labor & Pensions (HELP) Committee Democrats, comes almost a month after the committee, still looking to pass companion legislation to the House-passed 21st Century Cures bill , advan...
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    Congressional Spending Deal Offers $132m More for FDA in 2016

    As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year. The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act ( FDASIA ); $8.7 million for ...
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    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
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    FDA Legislation Tracker

    Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...