• Regulatory NewsRegulatory News

    FDA Begins Process of Overhauling Off-Label Communications Regulations

    The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices. The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District C...
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    Harvard Professors Call for Science-Based Pharma Marketing

    Two Harvard professors are taking issue with the recent landmark court decision allowing some "truthful and non-misleading" off-label pharmaceutical marketing in a new paper, saying “informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals.” Background The US Food and Drug Administration (FDA) generally does not allow pharmaceutical companies to promote drugs for unappro...
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    DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

    A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses. The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in ...
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    Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

    • 28 August 2014
    Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication. Now the US pharmaceutical industry's largest group, PhRMA, is weighing in on the guidance, giving it rare praise for what it calls the gu...
  • Global Healthcare Product Regulators in Talks to Form New Regulatory Supergroup

    US and international regulators are reportedly working to form a new global regulatory organization focused on leveraging and sharing resources and information among regulatory authorities. The existence of the organization was announced this week in London by US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, who was attending the Medicines and Healthcare Products Regulatory Agency's (MHRA) ninth Annual Lecture. "Regulators around the world have begun...
  • Researcher: Regulations Banning Gifts Unlikely to Pass Constitutional Muster

    • 14 June 2012
    Is a free donut an expression of free speech? At least one expert thinks so, and the strength of her argument could have a wide-ranging impact on the ability of states to regulate gifts from the pharmaceutical and medical device industry to physicians and academia. Writing in the June 2012 issue of the Journal of Health and Biomedical Law , Marcia Boumil, JD, an associate professor at the Tufts University School of Medicine, argues recently-established judicial preceden...
  • PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

    The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...
  • Dalli: Commission Looking to Overhaul Clinical Trials Directive

    John Dalli, the European commissioner for health and consumer policy, spoke 7 March about the need to review and modernize the Clinical Trials Directive before a joint event put on by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Roche Group. "This debate comes at a very good time - the Commission will come forward with a proposal to revise the Clinical Trials Directive later this year," said Dalli. Dalli noted clinical trials hav...
  • Hamburg: FDA Now Approving More Drugs During First-Round Than Ever Before

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg appeared before the House Committee on Appropriations 29 February 2012 to argue on behalf of FDA's Fiscal Year 2013 budget request. Hamburg made a number of notable regulatory assertions in her testimony to the committee. Among them: "FDA now has the highest first action approval rate for new drugs we have ever had." "We lead the world in the number and speed of drug approvals: of the 57 novel drugs...
  • EC's John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

    The European Commission's (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to "look at the sector of medical devices as a whole," saying that both the EC and national agencies need to review how medical devices are approved in the EU in a speech given to the press on 9 February . "As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had i...
  • Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg delivered a speech at the Commonwealth Club of San Francisco on 6 February in which she discussed FDA's dual role in protecting health and getting innovative products to market. "As FDA commissioner, I have been surprised by how many people ask whether I favor safety or innovation," said Hamburg. "I favor both." "Protecting the public health-while encouraging, not discouraging innovation must be the ...
  • Obama, Largely Silent on Healthcare in State of the Union Speech, Takes Shot at Medical Device Failures

    Last night's State of the Union (SOTU) Speech devoted just 44 words of a 6,957-word speech to healthcare-a striking departure from prior speeches that highlighted the Obama administration's actions on the Patient Protection and Affordable Care Act (PPACA). However, regulations-including medical device regulation-received some attention in the President's speech. In the middle of his SOTU speech, Obama turned to critics of his administration's regulatory policies, and...