• Regulatory NewsRegulatory News

    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
  • Feature ArticlesFeature Articles

    The FDA, prescription drug promotion, and its Bad Ad Program

    This article discusses pharmaceutical industry promotion for prescription drugs. The author provides an overview of the regulatory landscape from the US Food and Drug Administration’s (FDA) perspective followed by a discussion of the FDA’s Bad Ad Program which celebrated its ten-year anniversary in the summer of 2020. FDA's Bad Ad Program is an outreach program designed to help healthcare providers (HCPs) recognize and report potentially false or misleading prescription d...
  • Regulatory NewsRegulatory News

    As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

    In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats. But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's ...
  • EMA Calls for Revisions to be Made to Alzheimer's Guideline

    The European Medicines Agency (EMA) has announced the release of a new concept paper calling for the revision of its guideline on the development of products intended to treat Alzheimer's disease "and other dementias," saying a new approach is needed to accommodate patients who are pre-symptomatic or in the early stages of disease progression. The Need for a Guideline The concept paper is similar to a draft guidance released in February 2013 by the US Food and Drug Ad...
  • C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

    The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments. C-Path, which was founded in 2005 under FDA'...
  • US Regulators Look to Continue, Expand Support for Medication Adherence Campaign

    The US Food and Drug Administration (FDA) plans to continue providing funding to a campaign first started in 2010 to promote the importance of medication adherence to overall health-a potential boon to companies which have long argued that improper adherence can cause adverse events, result in worse outcomes for patients, cost government programs money and harm their revenues. FDA seemed to back those contentions in its 5 June 2013 Federal Register notice, explaining t...
  • FDA's 'Bad Ad' Program Marks Second Year of Operation

    The US Food and Drug Administration's (FDA) Bad Ad Program, an effort to encourage physicians and other healthcare providers to report "suspected untruthful or misleading prescription drug promotion," is doing some advertising of its own. In a "Year End Report" released this week, FDA's Office of Prescription Drug Promotion (OPDP) said it spent "significant time and resources" during the second year of the program's inception to increase the exposure of the Bad Ad progra...
  • Company Cited for Failure to Follow Numerous Medical Device cGMP Regulations

    • 25 April 2012
    A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food and Drug Administration (FDA). The company, which manufactures devices for neurological monitoring and neurosurgery, was hit with a bevy of regulatory citations by FDA, which noted  the company's products were "not in conformity with the Current Good Manufacturing Practic...
  • Romney Talks FDA, Medical Device Regulation

    Republican Presidential nominee Mitt Romney spoke Monday, 26 March before a gathering at San Diego medical device company NuVasive, telling the audience he thought the US Food and Drug Administration (FDA) is taking too long to approve medical products, including medical devices. While Romney was mostly focused on the Patient Protection and Affordable Care Act's (PPACA) provisions and the medical device tax, which is slated to go into effect at the end of this year, he...
  • New FDA Draft Guidance on DTC Television Advertisements

    The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public. Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...