Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued by the agency, are one of the ways that industry can gain insight into FDA’s thinking on a wide array of topics, including the regulation of speech related to drugs and biologics.

In the past few years, enforcement by OPDP has dropped off considerably – at least as measured in the number of regulatory action letters that were issued. Not so very long ago, the agency used to issue scores of letters in any given year – in 1998 there were over 150 letters issued. Thereafter the number of letters fell off though in 2009 – 2011, there was a slight increase. But then last year, OPDP slowed to a crawl, sending out letters to ten companies, less than half of the 22 sent the previous year and only about a third of those sent out in 2012.

But looking beyond the numbers at the letters sent the past few years, one can also readily see that the recipients of the letters tended to not be the pharma and biotech companies that you might readily be able to name. Smaller companies seemed to be predominant when it came to enforcement.

To see if this impression was correct, I used as a yardstick of company size the Pharma 50 published in Pharmaceutical Executive which lists the top 50 companies by sales.  I cross-referenced the names there with the names of recipients of the regulatory action letters over the past few years from my Warning Letter Database.  Here is what I found:

• 2015 – There have been only three letters issued by OPDP this year. Of those three, zero were included in the Top 50.
• 2014 – Of the 10 letters, one (10%) was received by a company in the Top 50.
• 2013 – Of the 22 letters in this year, five (23%) of the letters were sent to companies in the Top 50.
• 2012 – During this year, there were 28 letters sent out by OPDP ten (36%) were sent out to the Top 50.
• 2011 – OPDP sent out 31 letters, eight (26%) of which went to companies in the Top 50.

That is a total of 94 letters in all.  Twenty-four (25.5%) of which went to companies in the Top 50.

What does that say? On its face, nothing conclusive. Large companies are likely to have much more promotional language about more products but also likely to have more experience and probably more internal controls than less experienced companies.

However, one note – in 2010, there were 52 letters issued by OPDP.  Half of them went to companies in the Top 50.

Perhaps the reason is that there have been a number of emerging companies on the horizon, so the pool of smaller companies is expanding. In any case, it has represented an interesting trend of note in OPDP enforcement.