Drugs

Industry Advertising/Promotion Submissions Jump 12%

While CDER’s Office of Prescription Drug Promotion (OPDP) has been relatively quiet in its issuance of Warning and untitled letters the past two years, it appears staffers are probably keeping busy with an increased workload in advertising/promotion (Form 2253) submissions. Last year, OPDP received a total of 96,091 submissions, a 12% jump from the 85,485 received in 2014, according to an update (see slide presentation) by Office director Tom Abrams at the Drug Information Association’s annual meeting in Philadelphia 6/29.

FDA Warning and untitled letters to drug makers on their advertising and promotion violations dropped to an all-time low last year. OPDP issued nine such letters in 2015, one less than it issued in 2014. In contrast, OPDP had issued on average 28 letters annually since 2011. So far, only two letters have been issued in 2016. Many speculate that FDA’s recent losses in court on First Amendment grounds may be causing the decline. Abrams noted that the top three violations cited in regulatory letters were:

Omission and minimization of risk information
Omission of material facts
Overstatement of efficacy claims

Since 2014, Abrams said that OPDP has issued seven draft guidances — two on the distribution of scientific and medical publications, three on social media, one on consumer brief summaries, and one on electronic submissions of promotional materials. Other guidances are under development, he said, but declined to elaborate until they are further along.

Abrams’ presentation also touched on “best practices” for working with OPDP, especially providing complete submissions when requesting advisory requests or complaints about a competitor. He recommended that complaints provide as much information as possible and present the complaint in a manner that raises a public health concern. For regulatory submissions, he directed attendees to a 4/2015 draft guidance on “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising for Human Prescriptions Drugs.” He said that industry should submit consumer and professional materials separately and identify them accordingly in a cover letter or Form FDA 2253.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome