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    UK Industry Group Sees More Complaints Against Pharma Members in 2016

    The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the Association of the British Pharmaceutical Industry's (ABPI) code of practice, says it saw more complaints about drugmakers' promotional materials and activities in 2016 than in the previous year. In 2016, PMCPA saw a 41% jump in the number of complaints it received over 2015, with 76 complaints compared to 54. These complaints led to 100 cases covering 420 individual matters, as many of the...
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    CMS Revisits Biosimilar Payment Policy: Industry Comments Signal Expected Changes

    A tweak to a Centers for Medicare and Medicaid Systems (CMS) billing code system that could come later this week would have a big impact in making US biosimilars more competitive with their reference products. Background CMS' Medicare Part B program currently pays for biosimilars under the Physician Fee Schedule (PFS) based on the average sales price (ASP) of all biosimilar products within the same Healthcare Common Procedure Coding System (HCPCS) code, which means...
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    ABPI Extends Astellas UK Suspension for 12 More Months

    The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety." Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, inc...
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    Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy

    Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) with concerns about the biosimilar reimbursement policy from a recently issued final rule. The final rule, issued by CMS on 30 October 2015, stipulates that each biosimilar of the same refere...
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    Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice

    When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice. In addition to the basement storage fiasco for the French company Pierre Fabre, which the UK’s Pr...
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    NICE Halts Plans to Charge for Appraisals

    The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy. The controversial plan to charge for appraisals, first unveiled in October , would see companies pay fees of up to £282,000 for each cost-effectiveness assessment. NICE’s chief executive, Sir Andrew Dillon, said...
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    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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    FDA Extends Deadline for Some UDI Requirements for Medical Devices

    The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices. Specifically, the agency says it will enforce a statutory prohibition on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers for device labels and packaging for certain devices. In 2013, FDA issued its fin...
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    It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...
  • UK Organizations Band Together to Form New Clinical Trial Transparency Standards

    • 24 May 2012
    A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports PMLiVE . The coalition of groups, which includes the Association of the British Pharmaceutical Industry (ABPI), the General Medical Council, the Prescription Medicines Code of Practice Authority and The Academy of Medical Royal Colleges, is being called the Ethical Standards in He...
  • FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

    The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national drug codes (NDCs) for products lacking either a New Drug Application (NDA)or Abbreviated New Drug Application (ANDA) number. The Citizen Petition was filed in December 2011 by Dr. S. Albert Edwards, RAC, who requested FDA phase out the use of NDCs over a three-year period. C...
  • IFPMA Releases Updated Code of Ethics for Industry

    The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released an updated code of ethics 1 March that aims to broaden the scope of its code of practice to include "interactions with healthcare professionals, medical institutions and patient organizations." "IFPMA requires all member companies and member associations around the world to adopt and implement this new Code," the organization said in a statement. IFPMA counts most of the w...