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    Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

    Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a rulemaking that would require pharmaceutical list prices to be shown in direct-to-consumer (DTC) drug advertisements on television. The rule, which was finalized in May and is set to take effect in July, requires that television advertisements for prescription drugs or biological products with a list price of $35 or more con...
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    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
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    May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

    While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.” Vytenis Andriukaitis’s comments at a meeting of EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) in Luxemburg followed concerns raised this week by German and Irish delega...
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    FDA Warns of One Death Linked to Fecal Transplants

    The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT). FMT is typically used to help patients with the bacterium  Clostridium difficile who are not responding to standard therapies. 2013 guidance from FDA revealed that the agency intends t...
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    Senators Seek Details on Sharing US Genomic Data With Companies Linked to China’s Government

    Sens. Chuck Grassley (R-IA) and Marco Rubio (R-FL) sent a letter earlier this week to the Acting Inspector General of the US Department of Health and Human Services raising concerns about the US Centers for Medicare and Medicaid Services (CMS) paying for genetic testing or analysis services from companies with ties to the Chinese government. The letter singles out WuXi Nextcode Genomics (WuXi) and Shenzhen BGI Technology Company (BGI) as publicly touting their partnersh...
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    FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20 th biosimilar overall. Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition s...
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    Catalyst Sues FDA Over Approval of Rival Drug

    Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Ruzurgi, which was approved by FDA in May for children with LEMS, will likely compete off-label with Catalyst’s Firdapse (amifampridine), which first won approval in November 2018 but has a list price about twice as...
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    Hospitals Rely on FDA-Designated Outsourcing Facilities for Compounded Drugs, OIG Finds

    Among US hospitals that obtained non-patient-specific (NPS) compounded drugs from outside compounders, 89% of hospitals obtained them only from compounders that were registered with the US Food and Drug Administration (FDA) as 503B outsourcing facilities, a new report from the Department of Health and Human Services’ Office of the Inspector General (OIG) found. "Factors associated with quality, including registration with FDA as an outsourcing facility, are among the mo...
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    ‘Slower Than Expected’: FDA Tries to Prep Stem Cell Clinics for Upcoming Enforcement

    The three-year grace period for not enforcing premarket approval requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps) is more than half over, and the US Food and Drug Administration (FDA) said Wednesday that it has not received the responses from manufacturers that it expected. To combat this lackluster response rate from HCT/P manufacturers, including stem cell clinics, the agency is launching a temporary program (ending at the end of ...
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    EC Selects Four UDI Issuing Entities

    The European Commission (EC) last week revealed that GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) will be issuing entities for unique device identifiers (UDIs). The four companies submitted applications and were accepted by the EC to be a part of the system assigning UDIs under the EU’s new medical device and in vitro diagnostic regulations, as they satisfied the relevant criteria for d...
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    An Interview With MHRA’s Outgoing Device Director: Biggest Regulatory Challenge is Software Safety

    John Wilkinson, outgoing director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), answered Focus questions via email on everything from Brexit to the EU’s new medical device regulation (MDR).   In addition to offering some details on what will happen with the new 31 October Brexit deadline, Wilkinson, who is stepping down at the end of October , also discussed notified body capacity and said he believes the biggest challenge facing...
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    Mallinckrodt to Settle With DOJ for $15m as Another Complaint is Filed

    Drugmaker Mallinckrodt said Wednesday that it will likely pay $15.4 million to settle charges made by the Department of Justice (DOJ) related to sales and marketing activities of a company acquired by Mallinckrodt. But the DOJ also filed another complaint Wednesday under the False Claims Act , claiming that Mallinckrodt used a foundation to pay illegal kickbacks in the form of copay subsidies for its expensive drug known as H.P. Acthar gel, which is used to treat multi...