For those of us in the PR profession who regard the “pitch” for a press release as a single piece of communications, the U.S. Food and Drug Administration has informed us otherwise. The agency regards these as two separate vehicles and signaled increased scrutiny of both these common public relations practices.
In a letter to Cornerstone Therapeutics at the very end of October, the agency reprimanded the company for developing a media pitch, which promoted a favorable study for one of the company’s drugs without including any of the drug’s risk information in the pitch itself. The media pitch did, in fact, reference an attached press release, and that release contained all required risk information. But apparently, to the FDA, this wasn’t good enough.
So now we know. We need to be just as vigilent about including appropriate risk and safety information in the pitch to assure that it adheres to the same standards as a press release when it comes to making claims and providing risk information. It is this sort of increased regulatory scrutiny that highlights the value of specific expertise in health communications and the need to closely track and interpret the signals being sent by the FDA. The bias toward caution, for better or worse, has been supported by this most recent agency missive.