• Regulatory NewsRegulatory News

    DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

    A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. "When commercials list severe side effects along with those that are most frequent…it dilutes consumers' judgements of the overall severity of the side effects," write authors Niro Sivanathan, associate professor of org...
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    Gottlieb: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
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    Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

    The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors. Background In 2009, FDA began work to develop a structured approach to conducting benefit-risk assessments as part of an effort to bring more clarity and consistency t...
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    FDA Weighs Limited Risk Info in DTC Ads

    The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented. Currently, DTC drug ads are required to present a product's major risks alongside its benefits to ensure a "fair balance" of information. But FDA and industry have long debated over the best way to present that information. Acc...
  • Feature ArticlesFeature Articles

    Organizational Culture and Memory in Managing Risk in the Medical Device Industry

    This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality." Introduction According to the Italian Renaissan...
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    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...
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    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...
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    FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

    The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants. While the guidance was released without a public consultation on a draft version, FDA says it will consider comments on the final version and revise the guidance as necessary. "Over the years, FDA has received numerous...
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    FDA Updates on Two ICH Guidelines

    The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents. For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy , w...
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    Australia Proposes New Risk-Based Approach to Medicine Variations

    Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement. "These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before imple...
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    FDA Hedges: A Proposal to Better Share R&D Risks

    The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval proce...
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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...