Tag: FDA enforcement

FDA enforcement

DTC Advertising

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were cited by the FDA’s Office of Prescription Drug Promotion (OPDP) in Untitled Letters issued Dec. 12 to Celgene Corp. and Sanofi-US. These letters bring the total number of Untitled Letters issued this year up to […]

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CHC News

Report from the Coalition Executive Director

Report from the Coalition Executive Director

Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is certain – there is change ahead. To get the real skinny on what will happen to medical marketing, attend the Coalition for Healthcare Communication post-election meeting next Wednesday and Thursday in Washington. Speakers from throughout […]

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Regulatory/FDA

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

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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Regulatory/FDA

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this calendar year, it issued two Untitled Letters within two weeks for the same alleged infraction: promoting an investigational drug. In a Sept. 8 letter to DURECT Corp. and Pain Therapeutics Inc. (remoxy-untitled-letter), OPDP raised concerns […]

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Regulatory/FDA

OPDP Issues Just Two Enforcement Letters in First Half of 2016

OPDP Issues Just Two Enforcement Letters in First Half of 2016

July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) – just nine total enforcement letters – so far this year OPDP is lagging behind that figure, having issued only one Untitled Letter and one Warning Letter between the beginning of […]

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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 […]

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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 […]

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