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    Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds

    One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...
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    Pelosi Drug Pricing Bill Advances on Party-Line Votes

    Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US. No major amendments were adopted in either the Energy & Commerce or the Education & Labor committees’ meetings, although the amendments in the E&C meeting ranged from carving out specific disease treatments from negotiations to requiring the Health and Human Services Sec...
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    CBO: Pelosi Bill Will Save Hundreds of Billions, Reduce Number of New Drugs to Market

    The Congressional Budget Office (CBO) late Friday announced that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would reduce federal direct spending for Medicare by $345 billion from 2023 to 2029, but it would also lead to a reduction of approximately 8 to 15 new drugs coming to market over the next 10 years. The CBO report comes as rhetoric on both sides of the aisle has picked up in recent weeks, with industry group PhRMA referring to the bill, known as HR 3, a...
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    Nevada Fines Drugmakers $17M for Failing to Comply With Drug Pricing Law

    The Nevada Department of Health and Human Services this week sent letters to 21 diabetes drug manufacturers seeking $17.4 million in penalties for non-compliance with a new price transparency law. “This legislation requires the Department to compile a report of information related to prescription drugs used to treat diabetes. As part of the legislation, the Department of Health and Human Services (DHHS) can impose a penalty for companies who fail to provide the required...
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    Pelosi Unveils Plan to Lower Prescription Drug Prices

    As Sen. Chuck Grassley (R-IA) continues to push his own competing drug pricing legislation in the Senate, House Speaker Nancy Pelosi (D-CA) unveiled her proposal to lower prescription drug prices on Thursday, with a plan likely to please more liberal Democrats and further distance Republicans. At the heart of Pelosi’s plan is the idea to allow Health and Human Services Secretary Alex Azar to select between 25 and 250 drugs annually and directly negotiate with manufactur...
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    Do Biopharma Companies Really Spend More on Marketing Than R&D?

    As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues. From 2014 through 2016, various publications—from the Washington Post to Vox to MedCity News —published an eye-opening chart showing that nine of the top 10 large pharmaceutical companies (all but Roche) spent more on marketing than research and development (R&D). The source of the chart is a 2014 BBC article , which relied on GlobalData, to...
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    Judge Blocks Pharma Prices in TV Ads Rule From Taking Effect

    US District Court Judge Amit Mehta late Monday ruled that the US Department of Health and Human Services (HHS) lacks the authority to require drugmakers to post list prices in pharmaceutical direct-to-consumer (DTC) television advertisements. The HHS rule, which was set to take effect on Tuesday and finalized in May , called for television advertisements for prescription drugs with a list price of $35 or more to contain a statement indicating the Wholesale Acquisition ...
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    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
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    FDA Touts Quality Office’s Achievements in 2018

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.   OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviat...
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    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...
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    IFPMA Seeks Global ban on Gifts and Promotional Aids for Medicines

    As part of a push to align the rest of the world with the US and EU, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is seeking to establish a global ban on gifts and promotional aids for prescription medicines, wherever its member companies operate. “Any exceptions based on the custom of gifts to mark significant national, cultural or religious events (for example, mooncakes or condolence payments) have also been removed,” the group ...