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  • Regulatory NewsRegulatory News

    PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals

    The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier. The comments were made in response to FDA's assessment of its program for enhanced review transparency and communication for new molecular entity new drug applications (NME NDAs) and or...
  • Regulatory NewsRegulatory News

    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
  • Regulatory NewsRegulatory News

    Pharma Companies: FDA Wants New Info for FY2017 User Fees

    The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year. The reminder, which comes in the form of a "Dear Colleague" letter sent to drugmakers earlier this month, instructs companies to complete two attachments to inform the agency of any of a company's products and establishments that are subject to user fees. Under the Prescription...
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    IMS: Biosimilars Could Save Up to $110B in EU, US Through 2020

    With 56 new biosimilars in clinical development, IMS Consulting Group says in a new report that the biologic competitors could save health systems across Europe and the US as much as $110 billion through 2020. But the savings for both regions will vary considerably as payers have adopted a variety of approaches to encourage physicians to prescribe biosimilars, motivate manufacturers and require certain clinical evidence to support the prescribing of these treatments. Fo...
  • Feature ArticlesFeature Articles

    Pharmaceutical Marketing via Social Media

    This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication. Pharmaceutical marketing is the practice of promoting and selling medicines to patients through different media. The broad scope of this definition encompasses all means for the purpose of marketing and sales adopted by a company. A drug c...
  • Regulatory NewsRegulatory News

    HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

    The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms. HHS Secretary Sylvia Burwell kicked off the event by noting the steep cost increases for medicines, particularly for specialty drugs, which made up about $87 ...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

    A recent US district court decision could affect US Food and Drug Administration (FDA) interpretation and determinations in the orphan drug exclusivity area. Specifically, on 5 September 2014, the United States District Court for the District of Columbia issued its memorandum opinion in the case of Depomed Inc. v. United States HHS . 1 The case centers on the Orphan Drug Act , which provides incentives to pharmaceutical companies to research and develop drugs for rare ...
  • Regulatory NewsRegulatory News

    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....
  • Supreme Court Again Rules in Favor of Generic Pharmaceutical Industry, Supports Federal Preemption

    The current term of the US Supreme Court has already been a momentous one for the life sciences industry, having declared patents on naturally-occurring DNA invalid and legal settlement agreements commonly known as "pay for delay" agreements potentially illegal under federal competition law. Now the court has released a third potentially landmark decision, Mutual Pharmaceutical Co. v. Bartlett , in which the justices have decided that when it comes to so-called "failur...
  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
    • By
    In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...
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    FDA, Industry Outline Impact of PDUFA V at 2012 RAPS

    Renewed every five years, the Prescription Drug User Fee Act (PDUFA)  is one of the single most important and successful pieces of legislation affecting both the US Food and Drug Administration (FDA) and the pharmaceutical and biopharmaceutical industries. The legislation, originally conceived and passed in 1992, operates on a relatively simple principle: in return for industry-paid user fees, FDA is responsible for hiring additional staff with which to review drug...