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Kamp Commentary: Pricing Issues Take Center Stage in D.C.

May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp Participants at last week’s Coalition for Healthcare ... read more

Califf Calls for Off-label Promotion Code of Ethics

May 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA ... read more

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By John Kamp, Coalition for Healthcare Communication Executive Director May 11, 2017 – Although no one seems to like the ... read more

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States Make Moves to Ease, Restrict Medical Communications

March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may ... read more

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OPDP Cites Two Companies for YouTube Videos Featuring INDs

Jan. 3, 2017 – In its last blast of 2016, the FDA’s Office of Prescription Drug Promotion (OPDP) sent Untitled Letters to two companies on Dec. 21, both citing videos available on YouTube that allegedly promote investigational new drugs (INDs) as safe and effective for the purposes for which they are being investigated. These Untitled Letters bring the 2016 tally up to eight; with the three Warning Letters issued for promotional infractions, the total number of enforcement actions in 2016 was 11.

The Untitled Letter sent to Chiasma Inc. cites a video that promotes octreotide capsules (also referred to by the proprietary name, MYCAPSSA™), an IND for which there is no marketing authorization in the United States. Indeed, the FDA had previously told Chiasma that it did not believe the company’s application had provided substantial evidence or efficacy to warrant approval, and “advises Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency.”

The video at issue “presents claims that promote ocreotide capsules as safe and effective for the purpose for which it is being investigated” – to treat acromegaly.

“These claims make numerous positive and conclusory statements about the safety and effectiveness of ocreotide capsules, such as suggesting that ‘the drug is safe’ and ‘the effectiveness of the drug was proven in clinical trials.’” Although OPDP acknowledges that the statement “Product is an investigational new drug and not available for commercial distribution” is included as a SUPER on the screen for eight seconds at the end of the video, it states that “there is no disclaimer that would sufficiently mitigate the extensive claims and presentations throughout the majority of this video.”

The Untitled Letter sent to Zydus Discovery DMCC cites a video that suggests saroglitazar tablets (also referred to by the proprietary name LIPAGLYN™), an IND, are safe and effective to treat patients with diabetic dyslipidemia and hypertriglyceridemia with Type 2 diabetes specifically, although “there is no marketing authorization within the United States” for the drug.

According to OPDP, the video includes claims and presentations that promote the IND for purposes for which it has not been approved by the FDA, even though the product is approved in another country. “The claims and presentations, including the broad statements regarding the drug’s approval as the ‘world’s first’ furthermore are misleading,” the OPDP letter states, and suggests “that the drug is approved throughout the world, including the United States, when that is not the case.”

In both cases, the OPDP requests that the companies cease violating the FD&C Act and submit written responses to the OPDP by Jan. 6, 2017.