OPDP Enforcement Letters in 2018: Numbers Remain Low

Regulatory NewsRegulatory News | 10 January 2019 |  By 

2018 was a banner year for the US Food and Drug Administration (FDA) not only in terms of new drug approvals and generic and biosimilar approvals, but also in terms of an ever-increasing volume of announcements and official statements.

But for FDA’s regulation of pharmaceutical companies’ promotional materials, via the Office of Prescription Drug Promotion, the output was once again meager.

2018’s two warning letters – to Vanda Pharmaceuticals and Mannkind – and five untitled letters – for Eisai, Ascend Therapeutics, Arog Pharmaceuticals, Pfizer and Collegium Pharmaceuticals – was only slightly higher than 2017’s three warning letters and one untitled letter.

While the number of OPDP letters sent each year has steadily declined since the late 1990s, when the office routinely issued more than 100 letters per year, 2017 and 2018 mark only the second and third times the office has issued fewer than 10 action letters.

The downturn in enforcement coincided with the agency’s settlement of an off-labeling marketing case, following two other court cases that found that while there is no protection to companies for statements and claims that are either untruthful or misleading, the government cannot stifle free speech to promote a questionable public good.

New to 2018 was also the release of metrics on how well OPDP initially reviewed promotional campaign materials.

“FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs,” OPDP said.

The “core” launch materials contain key messages that will be used throughout the advertising campaign, as well as representative examples of other important disclosures, such as risk information, for the advertised product.

“By reviewing and providing advisory comments on core launch campaigns in a timely manner, OPDP can positively influence the initial marketing messages that companies disseminate about their new products and help ensure that the public receives accurate and balanced information about new prescription drugs,” OPDP added.

The metrics show that FDA consistently reviewed promotional materials within its 45-day window of the voluntary submission of these materials.

OPDP also receives complaints regarding potentially false or misleading promotions from health care professionals, consumers, drug sponsors and law firms, and the office’s goal is to acknowledge receipt of these complaints within 30 calendar days.


© 2022 Regulatory Affairs Professionals Society.

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