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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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    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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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    FDA Redrafts GMP Policies for Outsourcing Facilities

    The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to clarify provisions that became applicable to outsourcing facilities, following the 2013 enactment of section 503B under the FD&C Act that allowed drug compounders to register as outsourcing facilities with FDA. Outsourcing facilities must be GMP compliant and are subject t...
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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 ...
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    FDA Warns of Dosing Errors With Compounded Injectables

    The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.   "Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently," FDA writes.   For small volume parenteral drugs a...
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    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
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    Industry Groups Explain Competition Issues in the US Pharma Market

    Industry groups representing generic and brand-name drugs, pharmacy benefit managers (PBMs) and pharmacies offered their comments on a November meeting held at the Federal Trade Commission (FTC) on possible solutions to increase competition and lower pharmaceutical prices in the US. The organizations discussed differing views on what can be done, with the generic group noting its own declining prices and possible ways to combat abuses, the brand-name industry point...
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    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
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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...