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    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
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    In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

    The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny. The Letter In its so-called " Untitled Letter " to New Jersey-based Sciecure Pharma, FDA's Office of Prescription Drug Promotion (OPDP) said i...
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    FDA Sends Warning Letter Over Anesthesia Drug's Claims, but Company Defends Ads

    New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel. FDA's letter, dated 22 September 2014, references "educational technique flashcards" and a journal advertisement the agency said created the impression that Exparel has been approved for "new uses for which it lacks approval...
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    Comparative Claims in Advertising Make Drugs Seem Safer, More Effective

    Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month. Writing in the journal Social Science & Medicine , FDA Social Science Analyst Amie O'Donaghue and colleagues with FDA's Office of Prescription Drug Promotion (OPDP) and RTI International...
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    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
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    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
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    Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter

    When the US Food and Drug Administration (FDA) goes after pharmaceutical companies for violating federal marketing regulations, it usually goes after makers of pharmaceuticals for humans. But as a recent and rare Warning Letter illustrates, sometimes veterinary companies fall under the agency's scrutiny as well. In a 2 April 2014 letter to AB Science , a French pharmaceutical manufacturer, FDA veterinary regulators cited the company for allegedly marketing its veterinar...
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    FDA Chides Gilead for Google Advertisement, but is the Company Entirely to Blame?

    Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents , the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks. Background In July 2014, FDA released two guidance documents covering the use of social media. One of those documents, Internet/Social Media Platforms with Character Space Limitations— Pres...
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    LEAN In? Please Don't, FDA Tells Company in Letter Citing Double Meaning of Ad Campaign

    The US Food and Drug Administration (FDA) has issued an Untitled Letter to Citius Pharmaceuticals alleging that the company's website contains materials which create a misleading impression about the safety and efficacy of the company's weight loss drug, Suprenza. The letter, authored by FDA's Office of Prescription Drug Promotion (OPDP), is only the fourth sent by the agency this year for advertising-related allegations. But allegations contained within are largel...
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    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
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    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...
  • FDA Website Knockoff Markets Non-FDA-Approved Products

    In the mid-1990s, when "The Internet" was still in its infancy and government institutions were just beginning to develop an online presence, the world got perhaps its most notable look at how some purveyors will seek to profit off of website confusion. Twenty years later, though, it's still a problem, including for US healthcare product regulators. Background The problem then, as now, is that many people aren't always sure about which domain name suffix- .com, .org, .g...