WASHINGTON: Healthcare communicators are concerned that a Food and Drug Administration letter criticizing a pharmaceutical company's PR pitch may change the way agencies and their pharma clients promote products.
The FDA sent the letter to Cornerstone Therapeutics, a specialty pharmaceutical company, late last month criticizing a PR pitch sent on behalf of the company by Fleishman-Hillard. The federal agency considered the pitch “false or misleading because it omits important risk information” about its Curosuf product, which is used for rescue treatment of premature infants experiencing Respiratory Distress Syndrome.
A representative for Cornerstone declined to comment on the letter. A spokeswoman for F-H said: "Fleishman-Hillard's healthcare team understands and closely follows FDA regulatory rules and guidance, and we act in accordance with industry standards. In addition, with regard to client communications materials, it is Fleishman-Hillard's standard practice to work with each client's unique internal review processes to obtain their review and approval of all such communications materials."
Valerie Carter, SVP at Jones Public Affairs, said the FDA notice “could change the way we communicate with journalists.”
“When writing a pitch letter to get the attention of a reporter, brevity and simplicity are important,” she said. “Requiring extensive and detailed information could make what we're trying to do very difficult.”
In healthcare PR, it's common practice that the pitch letter consists of text above the press release, which is also in the body of the email message and not an attachment. The releases usually contain risk information, said Samantha Schwarz, executive director of healthcare at GolinHarris.
This appears to be the case in the pitch letter the FDA reviewed. However, in its letter to Conerstone, the federal agency said attaching a release “does not mitigate the complete omission of important risk information from the pitch letter itself.”
Industry leaders are waiting to see if other pitch letters will be cited by the FDA.
“It's a little early to say whether this is definitely a trend. It's something we're monitoring closely,” Schwarz said.
A high-ranking pharmaceutical industry leader said the FDA may be overstepping its bounds.
“It is highly questionable whether FDA has legal authority to regulate materials that were never intended for – and would never be seen by – prescribers or patients,” the source said.
Yet even if the FDA is crossing a line, organizations are unlikely to challenge the federal agency, one prominent attorney noted.
“Companies seldom fight regulators. If you have big drugs waiting for approval, you don't bite the hand,” said John Kamp, an attorney at Wiley Rein who specializes in advocating First Amendment and marketing issues with the government.
The FDA does not feel it has done anything out of the ordinary in this case, even though no one PRWeek spoke with could remember another time the federal agency cited a pitch letter in such a way.
“FDA takes a comprehensive view of the many venues that are used by companies to promote prescription drugs,” said Lisa Kubaska, a senior health promotion officer at the FDA, via email. “This approach is taken to be as effective as possible with our monitoring of prescription drug promotion and our risk-based enforcement actions so we can have the most positive impact on public health as possible.”
However, some in the pharmaceutical industry believe the letter could indicate a new normal for the FDA.
“I view this not so much as unusual as I do a natural next step in a continuum,” said Steve Cragle, a VP and head of global media relations at Merck. “So long as the communication is electronic, it can very easily find its way into the public domain.”
While not a story pitch, the FDA sent Johnson & Johnson a letter three years ago to warn the company about an online video for chronic pain drug Ultram ER. It felt the video “greatly misrepresent[ed]" the drug by suggesting that it can have a positive impact on a patient's mood.