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  • Regulatory NewsRegulatory News

    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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    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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    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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    Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

    The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay. Although none of the comments and arguments for reducing the price of pharmaceuticals were new, panelists and senators even seemed to disagree on what exactly is causing prices in the US to be so much higher than the rest of the world. Mark Merritt, president of the Phar...
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    Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages

    A new study finds that the US Food and Drug Administration's (FDA) 2006 initiative to get manufacturers selling unapproved drugs to submit the drugs for approval or remove them from the market led to higher prices and longer shortages for those drugs. Background Today, drugs must be reviewed by FDA for safety and efficacy or in some cases conform to an over-the-counter (OTC) monograph before they can be marketed in the US. However, in the years between the 1938 Food, D...
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    Trump Administration Officials Huddle at White House to Discuss Drug Pricing

    A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients." The confirmation follows reports from several media outlets citing sources who say the meeting, with US Food and Drug Administration Commissioner Scott Gottlieb among other officials in atten...
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    Canada Proposes to Amend Drug Pricing Regulations

    For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs. The move comes as the US government is undergoing a similar review of ways to bring down the price of drugs in the US, though one major difference between the neighbors is that Canada’s government has a means by which it can control the price of medicines. The US Congress is als...
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    Congress to Trump: Let’s Tackle Drug Pricing in User Fee Reauthorizations

    As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office. Among the suggestions is to attach drug price lowering provisions to the bill reauthorizing the US Food and Drug Administration (FDA) user fee agreem...
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    WHO Officials Offer Opposition to Value-Based Drug Pricing

    World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing. "What’s the value of life? This structure is good for luxury goods because you have a choice…if I’m sick with cancer, what’s the choice? We think value-based pricing is not feasible for products that are indispensable," Dr. Marie-Paule Kieny, assistant director-general of health systems and innovation at WH...