• Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

    The US Food and Drug Administration (FDA) has suffered its second setback in as many months after Magistrate Judge Theodore Katz of the District Court of New York ordered the agency to reconsider two petitions which seek to ban the use of antibiotics in animals. FDA had rejected both petitions, respectively submitted to the agency in 1999 and 2005, citing "the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings," reports...
  • FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • Senator Plans to Introduce Legislation Reversing Mensing Decision

    • 29 March 2012
    Senator Patrick Leahy (D-VT) moved earlier this week (26-30 March) to introduce legislation to overturn a loophole exposed by a recent Supreme Court case that Leahy claims "threatens the safety of consumers taking generic drugs." In Pliva v. Mensing , the Supreme Court ruled generic pharmaceutical manufacturers are not liable for tort claims based on labeling because federal law requires the drug's label to be identical to the Reference Listed Drug (RLD). "The  Me...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act: Day Three

    • 28 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) Medicaid expansion provisions and whether the 'individual mandate' is severable from the PPACA . In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of what you need to know about the case, the court, the hearings, the arguments and more. Medicaid: NPR - Supreme Court's Med...
  • After Prometheus Case, SCOTUS Sends Gene Patent Ruling Back to Lower Court

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) ruled Monday (26 March) to send a case by Myriad Genetics Inc. back to a lower court for review in light of its recent decision, Mayo Collaborative Services v. Prometheus Laboratories , in which the court decided Prometheus's patents on methods to determine the proper dosing for a disease were invalid . In Association for Molecular pathology v. Myriad Genetics , SCOTUS was to consider whether patents held by Myriad on t...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) 'individual mandate' provisions. In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of the essentials of what you need to know about the case, the court, the hearings and more. The Individual Mandate: Reuters - Supreme Court moves to heart of healthcare case The New York...
  • What You Need To Know About Today's Supreme Court Hearing on the Affordable Care Act

    • 26 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear three days of arguments on the Patient Protection and Affordable Care Act (PPACA) starting Monday, 26 March. In preparation for those arguments, Regulatory Focus has assembled a list of everything you need to know about the case, the court, the hearings and more. Case Summary: Washington Post Wonkblog - SCOTUS 101: A Wonkblog guide to health care oral arguments Kaiser Health News - The Health...
  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • Nestle Loses Patent Case That Could Have Stifled IVD Development

    • 20 March 2012
    The Supreme Court of the US (SCOTUS) ruled 20 March that Prometheus Laboratories, a subsidiary of Nestle, could not patent a method to determine the proper dosing for a disease , reports Reuters . The highly-watched court case overturned an earlier-and controversial-decision allowing Prometheus to patent adequate dosing methods. Critics contended Prometheus was patenting observational science itself, preventing physicians from treating their patients, developing new th...
  • Court Upholds FDA Labeling Regulations on Cigarette Packaging

    The Cincinnati Court of Appeals has upheld the US Food and Drug Administration's (FDA) authority to require cigarette companies to adorn their tobacco products with graphic labeling, ruling FDA's advertising regulations do not violate the companies' rights to free speech. "There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products," wrote...
  • Healthcare Reform Case to go Before SCOTUS in Two Weeks

    • 12 March 2012
    The Supreme Court of the United States (SCOTUS) will hear a series of challenges to the 2010 Patient Protection and Affordable Care Act (PPACA) of 2010 on 26-28 March, marking a historic challenge to a landmark piece of legislation with huge implications for the pharmaceutical, medical device and biotechnology industries. SCOTUS' review of the law will start on 26 March with arguments on whether the Anti-injunction Act ( AIA ) applies to the review of the PPACA . Th...