March 31, 2014

FDA imageTranslating the FDA’s Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.

Many of us had doubts that the FDA would publish any materials relating to FDAMA anytime soon.  However, the FDA surprised us by providing some guidance with its new Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices, which was published in February, 2014.  It is available here.

There are two major takeaways from this 20-page document:

  1. The only way a biopharma or medical device company could distribute a scientific or medical publication that contains information on unapproved use is through its medical affairs department, albeit with extensive care to abide with FDA rules.  FDA is saying “Don’t do it”.
  2. You CAN distribute Clinical Practice Guidelines (CPG’s) as long as the rules are followed and safeguards are put into place.

The risk/reward valuation gained by distributing Clinical Practice Guidelines (CPG’s) always made a lot more sense than sharing studies on unapproved uses.  If physicians are interested in understanding the implications of using a product outside of its approved indication, they already know how to find this research.  Modes include learning first-hand at medical conferences via posters and symposia, or through published journals.  Given the time constraints a practicing physician has, it is unlikely that a randomly appearing journal article will garner any notice.  A CPG would have far greater value and reception.

CPG guidelines should follow the Institute of Medicine’s standards for “trustworthiness”.  Standards must:

  • Be based on a systematic review of the existing evidence
  • Be developed by a knowledgeable, multidisciplinary panel of experts
  • Consider important patient subgroups and patient preferences
  • Be based on an explicit and transparent process by which the PG is developed and funded that minimizes distortions, biases and conflicts of interest
  • Provide a clear explanation of the logical relationships between alternative care options and health outcomes
  • Be updated when new evidence warrants modifications

Even though the FDA’s guidance for distribution of CPGs is extensive, it is a “good thing” that we know the rules of the road.  The goal of any sales representative (no matter the level), is to gain common ground and trust with the prescriber. If reputable, guidelines should provide this bridge.  It could be argued that providers could/should have this information anyway.  Guidelines are roadmaps to translating the science of disease management.

The FDA’s best practices for distributing scientific and medical publications have already been put into use by most of my clients.  The opportunity to expand CPG distribution could enhance a manufacturer’s relationship with health providers.  Guidelines do change frequently and physicians generally want to be on top of what is recommended (with some exceptions!).