Dec. 18, 2012 – Whether the U.S. Court of Appeals for the Second Circuit’s decision in U.S. v Caronia will reset the legal boundaries between the FDA and pharmaceutical manufacturers’ right to disseminate off-label information about approved drug products will be the topic of discussion at a Jan. 23, 2013, Drug Information Association Webinar moderated […]
Read moreTag: litigation
litigationJ&J Settlement Restricts Marketing Distribution of Journal Article Reprints
Sept. 10, 2012 – A recent settlement between Johnson & Johnson/Janssen and multiple states to resolve claims that the company promoted unapproved uses for its antipsychotic drugs Risperdal and Invega is significant not only because J&J will pay $181 million but also because, among several provisions, the settlement restricts J&J’s ability to distribute reprints of […]
Read moreMMM Previews Pharma Debates in DC: Prepare for a Wild Ride in 2012
Dec. 12, 2011 — Facing a need to decrease spending and boost revenues, the federal government will continue to target the pharmaceutical industry in 2012, according to a recent report in the December issue of Medical Marketing & Media. In the report, “Outlook 2012: Detailing DC,” author Matthew Arnold states that although pharma is fighting back, […]
Read morePhRMA Files Amicus Brief to Support Harkonen Fraud Conviction Appeal
Nov. 22, 2011 – Stating that “a robust dialogue” between pharmaceutical companies and the public “would be seriously chilled” if the U.S. Court of Appeals for the Ninth Circuit upholds the 2009 criminal conviction of former InterMune CEO W. Scott Harkonen for allegedly making false statements about Actimmune in a press release, the Pharmaceutical Research […]
Read moreRPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge
Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, legal experts, drug manufacturers and other industry interest groups are testing the waters to determine whether that opinion leaves the door open for new challenges to certain FDA regulations, specifically the agency’s ban on most […]
Read morePar Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech
Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par”s First Amendment right to provide truthful information to physicians and other healthcare providers about the off-label use of Par”s prescription drug, Megace® ES, which is approved for the treatment of anorexia, cachexia, or an unexplained significant weight […]
Read moreExperts Weigh In on Implications of Sorrell Decision
Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in the legal community because it extends greater First Amendment protection for marketing and expands that protection to data mining and use. In addition, many legal scholars openly are questioning whether the FDA can continue its […]
Read moreFrom The RPM Report: Data Mining Case Struck Down by Supreme Court; IMS Prepares for Future Battles
July 27, 2011 — A recent article written by Kate Rawson in The RPM Report provides an excellent summary of the Supreme Court”s decision in Sorrell v. IMS Health Inc. and discusses the decision”s implications for the pharmaceutical industry. Coalition for Healthcare Communication Executive Director John Kamp is quoted in this insightful article, which is reprinted below, with permission. […]
Read moreSorrell v. IMS: What Marketing Professionals Need to Know
By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the entire June 23 Sorrell v. IMS Health Inc. Supreme Court decision (No. 10-779), here is a quick summary of what happened and what drug marketing executives need to know. Top line, the Supreme Court majority […]
Read moreLegal Guide Spells Out Social Media’s Risks, Benefits
June 9, 2011 — A new White Paper by the law firm Reed Smith demonstrates that the perils of social media go well beyond waiting for guidance from the FDA. The guide, free to employees of 4As agencies and other supporters of the Coalition for Healthcare Communication, can be downloaded using the link below. “Okay, so […]
Read more