Category: Courts/First Amendment

Courts/First Amendment

Pacira Prevails in Exparel Settlement with FDA

Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a lawsuit it filed in September, which reaffirms the broad indications for Pacira’s non-opioid pain medication EXPAREL, results in the FDA’s rescission of a 2014 Office of Prescription Drug Promotion (OPDP) Warning Letter about the promotion […]

Read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 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 more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 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 more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 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 more

House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century Cures Act, which includes three closely followed provisions on off-label communication and Sunshine reporting. The bill, which stretches over 300 pages, also includes a broad array of amendments related to the National Institute of Health […]

Read more

21st Century Cures Legislation Poised for Full House Committee Vote This Week

May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House Energy and Commerce Committee vote last week, is set for a full committee vote this week, and could be up for a full House vote early this summer. The 21st Century Cures Act, championed by […]

Read more

FDA Plans for Off-label Communication Draft Guidance, Meeting

May 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 more

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical to healthcare delivery,” the FDA should interpret the Federal Food, Drug & Cosmetic Act “in a way that creates a clear, meaningful safe harbor for manufacturers to share with healthcare professionals a much greater amount […]

Read more

In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 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 more