With untitled letter, FDA signals press materials aren't exempt

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The FDA has issued a rare untitled letter concerning a pitch letter – a reminder that the agency does not consider press materials to be exempted from its oversight.

The target of the Oct. 31 letter was Cornerstone Therapeutics, which put out a press release for its Curosurf, indicated for rescue treatment of premature infants experiencing Respiratory Distress Syndrome. The agency said the pitch letter was false and misleading due to omission of risk info and presentation of unsubstantiated superiority claims – standard objections. What's unusual about it is the medium targeted – PR, not advertising or other forms of promotion.

“This is the first enforcement letter issued by OPDP in recent memory that focused on a press release, and I cannot ever recall them commenting on a pitch letter,” said Wayne Pines of APCO Worldwide. “OPDP has viewed press materials as promotional labeling for many decades. However, the pattern of enforcement letters indicates that press materials have not been a high priority for enforcement.” For those companies that hold their press releases to a lower standard than above-the-line communications, “this may be a wake up call,” added Pines.

FDA has scrutinized press materials as a promotional tool in the past, notes Ilyssa Levins, president of the Center for Communication Compliance (CCC). Press materials were at the center of the wire fraud case around InterMune's Actimmune in 2008. CEO Scott Harkonen was sentenced to six months home confinement and a $20,000 fine in that case. Further back, in the 1990s, FDA targeted video news releases.

“The letter is consistent with existing policy and a reminder that PR is considered promotion regulated by OPDP,” said Levins. “What's interesting is that regulatory compliance savvy for PR professionals has been an evolutionary process. The pitch letter is the last bastion of that.”

“Our clients are very sensitive to it, not because PR is under the microscope but because of how they communicate and control to make sure that they're doing everything according to regulatory guidelines,” said Laura Schoen, president of the global healthcare practice at Weber Shandwick, which is trained and certified in regulatory compliance through the CCC. Schoen said that in particular, agencies should be cognizant of potential issues around relationships with advocacy groups and the use of spokespeople – for example, whether a patient spokesperson might be considered a typical case based on prognosis or outcomes.

“This is a priority for our clients,” said Schoen, “and we need to show them that we understand what the issues are and are being hypervigilant.”

Communications is, Levins noted, the one avenue through which companies can engage external audiences about their products preapproval -- provided that they stay true to the principle of "scientific exchange," as opposed to promotion. That makes communications a potential lightning rod for OIG attorneys. The Code of Federal Regulations [Section 312.7(a)] says companies “shall not represent in a promotional context that an investigational new drug is safe or effective,” but adds that “this provision is not intended to restrict the full exchange of scientific information concerning the drug,” indicating that scientific data on experimental drugs can be used in press releases meant for physician, patient and public audiences.
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