Advertising, Marketing & Promotions Alert ... - Davis & Gilbert LLP

The Food and Drug Administration (FDA) has determined that a pitch letter to media outlets from a pharmaceutical company's public relations firm and an ...
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DECEMBER 2012

ADVERTISING, MARKETING & PROMOTIONS

>> ALERT FDA SAYS PITCH LETTER AND PRESS RELEASE WERE ‘FALSE OR MISLEADING’ The Food and Drug Administration (FDA) has determined that a pitch letter to media outlets from a pharmaceutical company’s public relations firm and an accompanying press release were “false or misleading.” The pitch letter omitted important risk information associated with the use of the drug and the pitch letter and press release presented unsubstantiated superiority claims. BACKGROUND The action by the FDA’s Office of Prescription Drug Promotion (OPDP), Division of Professional Drug Promotion, involved Cornerstone Therapeutics Inc. and its drug, Curosurf ® (poractant alfa) Intratracheal Suspension (Curosurf). Under the FDA-approved product labeling, Curosurf was used for the treatment of respiratory distress syndrome (RDS) in premature infants. The pitch letter sent on behalf of Cornerstone contained several efficacy claims for Curosurf, but did not communicate any risk information associated with the use of the drug. In addition, the pitch letter and the press release contained a number of superiority claims, including that a study demonstrated that the use of Curosurf resulted in “lower mortality rates compared to other animal derived surfactants” and that “Overall, Curosurf treatment for RDS was associated with a significantly reduced likelihood of death compared to Infasurf, and a trend toward reduced mortality when compared with Survanta.”

THE BOTTOM LINE Based on this document, the FDA found that at least in certain circumstances, media pitch letters, as well as press releases, must meet the same disclosure and support requirements as more traditional promotional materials – and that each promotional piece must, on its own, contain adequate risk information. Prescription drug companies and their advertising and public relations agencies should keep this potentially emerging application of FDA’s enforcement mechanisms in mind when distributing pitch letters, press releases, or other promotional materials.

OPDP LETTER In its letter to Cornerstone, OPDP explained that promotional materials are misleading if they fail to reveal facts that are “material in light of representations made or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.” OPDP then found that the failure of the pitch letter to communicate “any risk information” associated with the use of Curosurf misleadingly suggested that Curosurf was safer than had been demonstrated. Importantly, OPDP acknowledged that the press release accompanying the

pitch letter contained an “Important Safety Information” section for Curosurf. OPDP stated, however, that such an inclusion did not mitigate the “complete omission” of important risk information from the pitch letter itself. OPDP also explained that promotional materials are misleading if such materials contain a drug comparison that represents or suggests that a drug is “safer or more effective than” another drug when this has not been demonstrated by substantial evidence or substantial clinical experience. OPDP found that the “totality” of the claims in the pitch letter and press release “misleadingly” implied that >> continues on next page

Attorney Advertising 1103

DECEMBER 2012

ADVERTISING, MARKETING & PROMOTIONS >> ALERT Curosurf was superior to two other animal derived surfactants for reducing the rate of mortality associated with RDS, even though this had “not been demonstrated by substantial evidence or substantial clinical experience.” Moreover, OPDP found that the study referenced in the promotional materials was insufficient to support the applicable claims. OPDP stated that even though the press release

disclosed some of the study’s limitations, such disclosure did “not mitigate the misleading implication conveyed by the overall presentation” that Curosurf provided a superior mortality benefit compar