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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...
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    Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability

    The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity. The comment, released this week, follows FDA's issuance of draft guidance on biosimilar interchangeability in January and the release of other comments from stakeholders last month, who also sought more clari...
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    European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (4 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Hurries Through Drug Pricing Bill Before Parliament Closes for Snap Election Politicians in the UK have hurried through drug pricing legislation before Parliament closed ahead of a snap general election. The calling of the surprise election created a deadline for resolving a dispute between the two houses of the UK Parliament, prompting politicians to create a compr...
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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Defying Commons, Lords Again Press to Enshrine Support for Industry in Pricing Bill The House of Lords has again voted in favor of an amendment to a drug pricing act that would make the government take account of the need to “promote and support” the life science sector. Members of the second chamber of the United Kingdom parliament backed the proposed caveat despite th...
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    RAPS Virtual Career Fair, 30 March, Connects Regulatory Job Seekers, Employers

    • 28 March 2017
    Regulatory professionals looking for new employment opportunities and employers seeking regulatory staff will have another opportunity to connect when RAPS hosts its next Virtual Career Fair this Thursday, 30 March, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs allow regulatory job seekers to explore openings and talk with employers in real time from anywhere in the world. Confirmed exhibitors for the 30 March fair are: Baxter International BD (B...
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    Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals

    The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program. The finalization of the rule, first proposed in 2010, follows fierce criticism of the plan from industry groups PhRMA, BIO and companies including Bayer and Teva. The final rule calls on drug companies to: calculate the 340B ceiling price on a quarterly...
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    FDA Releases Guidance on Software as a Medical Device for Consultation

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF). Proposed Guidance According to IMDRF, the goal of the guidance is "to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]." ...
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    European Regulatory Roundup: Proposal for a European Drug Pricing Initiative (6 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Pressures Commission to Create Europe-Wide Drug Pricing Initiatives The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has called for continent-wide initiatives to improve access to medicines. In a draft report, ENVI takes the biopharma industry to task for prioritizing profits, not patients, when making research d...
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    What Drugs Really Cost: GAO Wants CMS to Find Out

    In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). What’s more, GAO is calling on Congress to ensure that CMS has the authority to request source documentation to periodically validate drug companies’ pricing data, wh...