Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the “truthful and non-misleading” communication of unapproved uses, industry has been anxiously awaiting the FDA’s next move, especially after the agency stated in May 2015 that it would hold a hearing on this matter. The wait […]
Read more
May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, […]
Read moreMay 2, 2016 – In order to make reasonable coverage decisions about new medicines, payers need access to information from drug companies about those medicines prior to their FDA approval, a practice that currently is restricted under FDA policy, according to a recent blog post in The Catalyst, a Pharmaceutical Research and Manufacturers of America […]
Read moreApril 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the […]
Read moreMarch 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts continue to hear cases that are being decided in favor of allowing.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal. companies to share truthful and non-misleading […]
Read moreFeb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP). “While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate […]
Read moreNov. 16, 2015 – From tax inversions to the proposal to reduce ad tax deductions for marketing to being named an “enemy” by Hillary Clinton, it is clear that as the march toward the 2016 presidential election continues, the potential changes ahead for pharmaceutical companies could be substantial, according to two industry experts speaking at […]
Read moreOct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it appears that the FDA may have to begin accepting alternative evidence to support truthful and non-misleading promotional claims, according to Douglas Hallward-Driemeier, partner, Appellate and Supreme Court Practice, Ropes & Gray. As demonstrated by the […]
Read moreSept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA cannot prohibit companies from communicating truthful and non-misleading speech about the off-label uses of their products, a second lawsuit calling the FDA’s marketing enforcement practices into question has been filed in the U.S. District Court […]
Read moreAug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to offer the first regulatory compliance eLearning program to healthcare agencies and publishers. “As the regulatory environment becomes more complex for communications professionals promoting drugs and devices, the CHC/CCC partnership makes it practical, efficient and affordable […]
Read more