• 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...
  • EPA Case Could Imperil FDA Warning Letters

    A unanimous decision last week by the Supreme Court of the United States (SCOTUS) against the US Environmental Protection Agency (EPA) could place warnings letters sent by the US Food and Drug Administration (FDA) into a quagmire of litigation, report various sources. In Sackett v. EPA , SCOTUS ruled the Administrative Procedure Act-the act governing how FDA and other federal agencies create regulations and make decisions-did not preclude the litigants from immediately ...
  • 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...
  • 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...
  • 30 Tons of Unused Drugs Left At Sites

    • 02 March 2012
    Alameda County, CA, is ready to pass a law requiring pharmaceutical companies pay for disposal of unused drugs. More than 30 tons of unused pharmaceuticals were found at sites in the San Francisco Bay area, and the county is concerned about those drugs getting into the wrong hands or ending up in the water supply, according to a report by Fierce Pharma Manufacturing . The new law would make companies financially responsible for a disposal program run by the county's en...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...
  • Obama Administration, Plaintiffs File PPACA Briefs

    The US Department of Justice (DOJ) and a group of 26 states ("state petitioners") both filed briefs with the Supreme Court of the United States (SCOTUS) on Friday, 6 January outlining their respective arguments regarding the Patient Protection and Affordable Care Act's (PPACA) constitutionality and the severability of certain components of the law. The DOJ brief focuses on the question of whether or not "the minimum coverage provision is a valid exercise of Congress...