OPDP not happy with Diclegis promo

Share this article:
OPDP not happy with Diclegis promo
OPDP not happy with Diclegis promo

A prescription morning sickness medication is back on the market for the first time in 30 years, but the honeymoon phase is already over. A letter sent to healthcare providers promoting the drug has captured unwanted attention, and triggered an untitled letter from the Office of Prescription Drug Promotion (OPDP).

The November letter to drug maker Duchesnay, which runs about two-and-three-quarter pages (not including signature lines) is far longer than the promotional item in question, which runs under 200 words (not including greeting and sign-off), a comparison that somewhat amplifies what OPDP finds lacking.

Among regulator's issues with the letter that mentioned the drug's mid-May launch: omission of all risk information associated with the prescription medication that is intended to alleviate pregnancy-related nausea and vomiting. OPDP wrote that failing to include this information in the letter “misleadingly suggests that Diclegis is safer than has been demonstrated.”

OPDP also takes the company to task over the failure to include the full FDA-approved product labeling, as well as providing only the brand name, Diclegis, and not the established name, doxylamine succinate and pyridoxine hydrochloride, as required.

Share this article:

Email Newsletters

More in News

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

Rep access continues to shrink

Rep access continues to shrink

Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.