PhRMA, BIO Principles for Off-Label Communication

Presumably tired of waiting for FDA to make sense of its position on off-label promotion given many First Amendment losses in the courts, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have issued their own industry practice principles on off-label communications. Attorney James Beck (Reed Smith) writes in an online blog post (includes link to the principles document) that the two trade groups “are drawing a line in FDA’s regulatory sand, telling the agency and their own members that they will fill the gap caused by administrative dithering themselves. Notably, since PhRMA has already shown its willingness to litigate First Amendment issues against FDA, we would not be surprised to see these guidelines form the basis of industry’s First Amendment position in future court challenges.”

The groups say the principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful, and non-misleading communications to inform healthcare professionals about safe and effective use of medicines.

The post lists the nine principles cited by PhRMA and BIO. Beck says there also appears to be an unspoken 10th principle: FDA should remove itself altogether from the business of regulating purely scientific speech, such as presentations at medical conferences, because scientific discourse is not subject to the principles and should not be regulated by FDA.

“All readers should note that these industry principles are rather unprecedented in their disregard of FDA’s outdated regulatory scheme with respect to off-label promotion, which (at least outside of the Second Circuit) still purports to impose a flat ban on truthful off-label speech by regulated manufacturers,” Beck writes. “But then FDA’s stonewalling on this issue, in the face of repeated adverse court decisions, is equally unprecedented. PhRMA and BIO are in effect telling FDA how the agency should re-do its approach to off-label promotion, if FDA wants to avoid additional legal challenges. PhRMA and BIO are telling FDA that facts are facts, and speakers are speakers, so that truthful presentation of scientific information should be governed by the same rules, chiefly encouraging full disclosure, regardless of the source of the information or whether the particular use at issue is on the label. That’s the line in the sand.”