FDA Violation Letters at All-Time Low in 2015

January 11, 2016

Pharmaceutical Executive

January 2011, 2016.

In 2015, the US pharmaceutical industry saw a significant decrease in the number of violation letters issued by FDA’s Office of Prescription Drug Promotion (OPDP)–A decrease that marks an all-time low for the industry, as originally reported by Eye on the FDA’s Mark Senak.

While the drop to nine violation letters in 2015 is a small decline from the 2014 total of 11, it is a significant decrease from the 52 letters issued in 2010. Since the bump in 2010, the industry has seen in a steady decline. The numbers dropped to 31 in 2011, and then to 28 in 2012. The number of letters took a significant dive between 2013 and 2014, dropping from 24 to 11.

Of the nine letters issued in 2015, only two of them were warning letters;  the other seven were labeled “untitled”. The two warning letters were issued to Duchesnay, Inc and ECR Pharmaceuticals. Duchesnay made headlines in late August after celebrity Kim Kardashian promoted Diclegis (doxylamine succinate and pyridoxine hydrochloride), a drug used for morning sickness, on Instagram, Twitter, and Facebook. OPDP sent the company a warning letter after they received information that the posts did not accurately represent Diclegis’ risks. ECR Pharmaceuticals was issued a warning letter after a print advertisement for TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex), extended release capsules used to treat the common cold, failed to accurately describe the drug’s risks.

Overall the OPDP has been only moderately vocal about FDA policy for the online promotion of drug products. In June 2014, OPDP issued draft guidance on the use of Internet and social media profiles. The agency attempted to further explain how to correct information about prescription drugs and medical devices online. The guidance cites various scenarios in which a company may be inclined to correct misinformation posted on websites run by third parties. While the guidance provides a jumping-off point for companies, as Mark Senak, senior vice-president at FleishmanHillard pointed out in the blog Eye on FDA, there are still many questions that remain. 

“The small amount of guidance put out by FDA on the topic fails to address the breadth and depth of the questions the agency asked in 2009 when it held a two-day public hearing on the Internet and social media-a meeting which set the framework for answers to outstanding questions,” Senak said in Eye on the FDA. “Not only are there many gaps, but the guidance documents that have been issued raise almost as many questions and they answered.”

In a statement to STAT News, an FDA spokesperson said a snapshot of warning letters from the agency may not accurate represent the work OPDP has done throughout the year.

“It is apparent that that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.  Reviewing the number of compliance actions that OPDP takes within a year time frame does not take into account the work that OPDP does on the other priorities to assist companies with compliance.”

Source: Eye on the FDA, STAT News, FDA