Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in 2016, it remains focused on enforcement through other means, such as issuing guidance documents, and reviewing draft product labeling and launch materials to promote voluntary compliance, according to OPDP Director Tom Abrams. Abrams, who spoke […]
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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 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 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. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin Pharma Inc.’s request for an injunction to stop the FDA from enforcing rules that prohibit companies from communicating to physicians truthful and non-misleading information about the off-label uses of their products. Below, Coalition for Healthcare […]
Read moreMay 11, 2015 – With off-label provisions in the 21st Century Cures legislation in the works and the courts bearing down on the FDA regarding First Amendment protection of industry’s truthful, non-misleading speech about off-label uses of approved products, it appears that a bridge between the agency’s long-held positions and industry’s desire to speak to […]
Read moreSept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it “threaten[s] core First Amendment rights,” an amicus curiae brief filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) asks the U.S. District Court for the Eastern District of California to dismiss the case. PhRMA […]
Read moreJan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia as a minor blip on its off-label regulation radar, the decision is part of a growing body of evidence which indicates that the agency will not be able to stay its strident […]
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