Drug Manufacturer Obtains FDA Approval, Violates Advertising Standards Three Hours Later

| 22 November 2013 |  By 

The Office of Prescription Drug Promotion (OPDP), the US Food and Drug Administration's (FDA) prescription drug advertising regulator, appears to be on the warpath this month, releasing seven letters to companies since 29 October 2013 alleging various deficiencies. And while most pertain to the same problems, one sent on 12 November 2013 includes an alleged violation not often seen in its Untitled Letters and an even more unusual circumstance.

The latest Untitled Letter was sent to Duchesnay Inc, the Pennsylvania-based manufacturer of Diclegis, a drug recently approved for the treatment of nausea and vomiting during pregnancy.

As Focus explained at the time of its April 2013 approval, the drug obtained FDA approval in the long shadow of other so-called "morning sickness" drugs like Thalidomide which had caused birth defects. A drug similar to Diclegis, Bendectin (doxylamine succinate/pyridozine hydrochloride) was pulled off the market in 1983 after allegedly causing birth defects. Those allegations were later determined to be false.

But agency regulators seem less concerned with the drug's history than with its current marketing efforts, including a letter sent to healthcare practitioners the day the drug was approved, possibly marking a new speed record for the time between product approval and the first alleged marketing violation.

FDA's approval notice for the drug hit the press wires at 7:10 a.m. on 8 April; Diclegis' marketing piece is time-stamped at 10:45 a.m. that same morning.

The 12 November Untitled Letter references a slate of allegations that are common to many letters, as well as some that are highly unusual.

One of those unusual violations pertained to the company's failure to adequately present its established name. Under 21 CFR 201.10(g)(1), companies need to include the generic name of the drug (doxylamine succinate and pyridoxine hydrochloride) in direct conjunction with the most prominent instance of the drug's proprietary name (Diclegis). The letter sent to healthcare practitioners did not include the generic name of the drug-a particularly glaring error given that this might be the first time many doctors would be seeing the drug's name.

The same letter-relatively short at around 200 words-was also called out by OPDP for failing to contain adequate directions for use. "We note that the letter does not appear to have been disseminated with the full FDA-approved product labeling for Diclegis, in violation of 21 CFR 201.100(d)." The violation is rarely referenced by OPDP in its letters, most likely because nearly all communications contain copies of the full prescribing information.

Other deficiencies noted in the letter include omitted limitations on use and the omission of all risk information. The company was given until 26 November 2013 to respond to OPDP's allegations.

FDA Untitled Letter

Promotional Material


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy