Showing 1 – 5 of 5
Relevance | Newest | Oldest |
  • Confidentiality Orders and Public Interest in Drug and Medical Device Litigation

    Abstract Full Text
    JAMA Intern Med. 2020; 180(2):292-299. doi: 10.1001/jamainternmed.2019.5161

    This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts.

  • Legal Challenges to State Drug Pricing Laws

    Abstract Full Text
    JAMA. 2018; 319(9):865-866. doi: 10.1001/jama.2017.20952

    This Viewpoint discusses legislative efforts at the state level to monitor or regulate drug prices and reviews legal challenges raised by industry in response to these efforts.

  • Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS

    Abstract Full Text
    JAMA. 2018; 319(1):21-22. doi: 10.1001/jama.2017.16477

    This Viewpoint uses the legal dispute between Amgen and the US Food and Drug Administration (FDA) regarding the FDA’s denial of market exclusivity for cinacalcet to discuss the FDA policy granting 6 months of market exclusivity as an incentive for manufacturers to conduct efficacy and safety studies in child populations.

  • Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads

    Abstract Full Text
    JAMA Intern Med. 2017; 177(2):157-158. doi: 10.1001/jamainternmed.2016.7151

    This Viewpoint discussed drug companies’ disputed First Amendment rights and the US Food and Drug Administration’s enforcement authority.

  • Free Speech and Pharmaceutical Regulation—Fishy Business

    Abstract Full Text
    JAMA Intern Med. 2016; 176(3):295-296. doi: 10.1001/jamainternmed.2015.8155

    This Viewpoint discusses the implications of recent circuit court decisions regarding commercial speech and off-label marketing of prescription drugs.