When FDA enforcement wanes, so does understanding of rules

When it comes to talking about their products, pharmaceutical and biotech manufacturers have certain guardrails.

For example, they cannot talk about the benefits of a product without including risk information or promote a drug for a use for which it has not been approved. In short, communication must strictly reflect the label that was approved by FDA when the drug or biotech product was approved. When company speech goes outside the guardrails, FDA’s Office of Prescription Drug Promotion (OPDP) sends the company an enforcement letter.

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During the last week of August, OPDP sent out the latest such letter to a manufacturer. There was nothing terribly unusual about the letter except for the fact that it was one of only three issued this year. If OPDP continues for the balance of the year at this pace, it will be the lowest level of visible enforcement in two decades.

The track record is one of stark decline. In the late 1990’s OPDP, then known as the Division of Drug Marketing, Advertising, and Communications (DDMAC), issued well over 100 letters a year. During the early years of the Bush Administration, those numbers dropped considerably to between 20-25 letters per year, but picked up again in 2008 when there were 41 letters sent and 2009 when there were 52. However in the past few years, the numbers have once again dropped, this time to single digits. What happened and why does it matter?

As to what happened — many FDA watchers have wondered. Maybe over the years, industry is just getting better at compliance. Or is it a matter of agency resources? Has FDA decided that its time — and money — is better spent on other activities?

At the beginning of 2016, in response to media inquiries about the diminished enforcement, FDA stated that one cannot expect to get a complete picture of the agency’s enforcement by looking at a snapshot of time for the issuance of enforcement letters.

That may be true, but several years is not really a “snapshot”. And while one may not be able to get a complete picture of FDA’s enforcement by looking at warning letters, the fact is one cannot get a good picture by looking anywhere else. An examination of the agency’s transparency reporting tool, FDA Track, OPDP has only one parameter that is reported on — its response rate to complaints submitted by the agency.

Why is it important? FDA has two primary means of enunciating policy around enforcement. One is through the issue of guidance documents and the other through the issuance of these enforcement letters. In 2009, following a two-day public meeting on regulating pharmaceutical speech and digital media, the agency was expected to put out guidance. Meanwhile patient use of social and digital media to consumer healthcare information grew by leaps and bounds.

It was not until 2014 that the agency issued any meaningful guidance, but the job was left incomplete. Every year, FDA publishes a Guidance Agenda for the year and in 2015 that included one for the use of links to third party websites — a topic that again appeared on the 2016 agenda published by FDA.

In other words, if OPDP isn’t producing letters, and isn’t producing guidance, where is the public to look to understand how it is shifting priorities when it comes to enforcement. It is not an unreasonable question, and there is every reason for FDA and OPDP to provide a reasonable answer.

Mark Senak is a consultant for pharmaceutical and biologic companies. He works for international communications firm FleishmanHillard in Washington and writes a blog called EyeonFDA.


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