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  • Regulatory NewsRegulatory News

    FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer

    The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance . With the approval of the new labeling, FDA said it has also closed its investigation of a trade complaint , initially filed as a citizen petition , against Bayer concerning the device. FDA spokesperson Angela Stark told Focus the investigation included a review of E...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

    The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure. While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated. However, these changes are unlikely to settle concerns from patients who say they have been harmed by ...
  • Regulatory NewsRegulatory News

    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
  • 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...
  • Feature ArticlesFeature Articles

    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Germany: IQWiG Recommends Combination Rilpivirine for HIV

    In a statement on 5 June 2012, the German health technology assessment body Institute for Quality and Efficiency in Health Care (IQWiG) said it would reverse its  April 2012 decision not to recommend Eviplera (rilpivirine) for HIV in fixed combination.  The agency said in a statement its change in determination was due to the manufacturer having submitted additional information supporting this dosage form. The company used an alternative so-called vi...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    • By
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • 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 ...
  • Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication

    The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication . FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications. The action followed a pu...
  • WellPoint Using IBM's Watson to Support Clinical Decision-Making

    • 04 January 2012
    • By
    IBM's Supercomputer, Watson-best known for its appearance on Jeopardy! -will be put to work for insurer WellPoint with the help of the Ceders-Sinai Samuel L. Oschin Comprehensive Cancer Institute. The project is the first step in a partnership between WellPoint and IBM that was announced in September, 2011 . The goal of the project is to develop tools that will enhance the decision-making ability of clinicians involved in the field of oncology. It is envisioned that W...