Park Language May Be On The Way In FDA Warnings To OTC Firms

Food and drug attorney Frederick Stearns predicts FDA soon will include Park Doctrine language threatening criminal charges against individuals at OTC firms, in part because the language appears in letters to dietary supplement firms.

FDA soon could threaten over-the-counter drug industry executives with criminal liability for regulatory violations by including Park Doctrine language in warning letters, food and drug attorney Frederick Stearns predicts.

FDA issues a “relatively modest” number of warning letters to OTC firms, Stearns acknowledged during a presentation at the American Conference Institute’s OTC conference in New York on Oct. 30.

As of Oct. 15, FDA had issued 21 OTC warning letters in 2013, up 24% from 17 in 2012. In 2011 the agency sent 26 letters to OTC firms, but only 20 in 2010 and 19 in 2009.

However, trends in warning letters suggest Park Doctrine language may be on the way, said Stearns, a partner at Keller and Heckman in Washington.

Roughly a third of the letters to OTC firms so far in 2013 addressed good manufacturing practice violations, an area that has plagued the dietary supplement industry and recently prompted FDA to take a hard-line approach threatening misdemeanor prosecutions against accountable corporate officers at some supplement manufacturers, Stearns noted.

“I wouldn’t be surprised if we started seeing FDA looking to include some of that Park Doctrine language in the OTC area as well,” he said.

Stearns said the GMP violations popping up in OTC warning letters – such as failure to conduct identity testing, sufficiently investigate complaints and reject components that do not meet specifications – track those identified in GMP compliance letters FDA sent private-label supplement distributors in April that stated potential Park Doctrine enforcement (Also see "American Conference Institute In Brief" - Pink Sheet, 15 Jul, 2013.).

Factors FDA Considers When Evaluating Park Doctrine Prosecution

In 2011, FDA outlined factors it considers when deciding whether to pursue criminal charges against individuals under the Park Doctrine, which allows the government to hold executives and others responsible for misdemeanor violations even if they had no prior knowledge of the conduct (Also see "FDA Posts Criteria For Targeting Executives As Responsible Officers" - Pink Sheet, 14 Feb, 2011.). Health care regulation attorney Frederick Stearns noted the key factors include the quality of the legal and factual support for the proposed prosecution and whether:

• the violation involves actual or potential harm to the public
• the violation is obvious
• the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings
• the violation is widespread
• the violation is serious
• the proposed prosecution is a prudent use of agency resources.

While FDA has not included Park Doctrine language in a letter to an OTC firm, the agency likely soon will to drive home the importance of following GMP regulations and “to get the attention of the responsible official who can cure the defects,” Stearns said.

He suggested the supplement industry received Park Doctrine warnings before the OTC industry in part because OTC manufacturing warning letters are rarer, but also because the agency is more frustrated with the supplement industry’s overall GMP compliance.

Supplement GMPs “have been in full effect for everybody for at least three years now, and for bigger companies it was even four or five years, so there has been a lot of discussion about how the agency really sees a pretty woeful state of compliance and … the addition of the Park language may be a reaction to a feeling that there are a lot of players in the supplement industry that simply aren’t paying attention, don’t care, don’t think it is that important or some combination of those things,” Stearns said.

“It is intended to be an attention-grabber,” he added.

FDA said in 2010 it would pursue more criminal prosecutions to hold corporate officers responsible, but the annual number of convictions resulting from criminal investigations it initiated in 2011 (255), 2012 (262) and so far in 2013 (216) has not reached pre-2010 levels (370 in 2009).

However, the numbers do not necessarily mean FDA is easing up on enforcement or not following through on its promise, Stearns added. Rather, firms should remain alert and strive for compliance because the difference in convictions “may just be a matter of the types of cases that FDA is focusing on,” he said.

[Editor’s note: this story was contributed by “The Tan Sheet,” which provides in-depth coverage of the OTC and supplements industry.]