Developing promotional materials and campaigns for the coming year can be fraught with peril if you’re not up on the latest FDA regulations and legal requirements.
When it comes to navigating the regulatory terrain and successfully moving the business forward with minimal risk, the watchword for all the stakeholders in the pharma industry—marketing, sales, managed care, regulatory, legal, compliance and medical—is collaboration. This will be truer than ever in 2013 as FDA regulations continue to tighten and there are landmines aplenty. Whether the risk is known, evolving or emerging, pharma companies and their promotional agencies must consider the implications of operating in this year’s regulatory environment. Here’s a roadmap to take on the journey:
Known Risks
Traditional FDA Marketing Enforcement: The Food and Drug Administration (FDA) will continue to pursue enforcement actions against marketing materials from regulated drug and device firms that fail to comply with their rules and policies based on the Federal Food, Drug, and Cosmetic Act (FDCA). Revisions to the FDCA have also broadened the authority of the FDA, which now has the power to impose fines in a wider range of cases.
FDA staffers actively encourage healthcare professionals (HCPs) to report potential advertising/marketing violations to the Office of Prescription Drug Promotion (OPDP) through the “Bad Ad” campaign. The program, which educates HCPs about the role they can play in helping ensure that advertising and promotion is truthful and not misleading, increases the effectiveness of OPDP’s surveillance program. The FDA continues to look for omission/minimization of risk, unsubstantiated claims, overstatement of efficacy, omission of material facts, broadening of indication and promotion of unapproved uses, to name a few of the topics for regulatory actions.
The FDA also put a fine point on promotional material enforcement with its October 2012 regulatory action related to an untitled letter sent to Cornerstone Therapeutics for the premature infant medication Curosurf’s public relations (PR) activities. The FDA’s letter is consistent with existing policy and a reminder that PR is considered promotion regulated by OPDP. What was interesting about this untitled letter is that FDA targeted a pitch letter, which is a bread and butter tactic used by PR professionals to frame the information in an accompanying press release. The FDA said that the pitch letter omitted risk information and presented unsubstantiated superiority claims—all of which is false and misleading.
The pitch letter may be the last bastion for FDA regulatory enforcement. PR regulatory issues have been largely under the radar. In the 1990s, video news releases (VNRs) came under the microscope and were clearly defined as promotion by the FDA. In a letter sent to pharmaceutical companies, the FDA said it would, for the first time, require companies to submit VNRs for review when they are sent to television stations. And while this enforcement caused a flurry of activity, the focus on compliance died down fairly quickly and everyone went back to business as usual.
It wasn’t until 2008 that the practice of PR once again was in the headlines with the InterMune case tied to a press release. The former InterMune CEO was indicted for his role in the creation and dissemination of false and misleading information about the efficacy of its drug Actimmune. According to the indictment, InterMune issued a press release publicly announcing the results of an Actimmune clinical trial. Although the clinical trial failed, the press release portrayed Actimmune as helping patients live longer.
Another interesting development at the end of 2012 was the U.S. Court of Appeals for the Second Circuit (based in Manhattan) decision to reverse the conviction of Alfred Caronia, a sales representative from Orphan Medical Inc., who admitted that he intentionally promoted its drug Xyrem for uses not approved by the FDA. Caronia claimed that the off-label promotion was accurate and protected as “commercial speech” under the First Amendment. The court ruled in a 2-1 decision that the prosecution had originally violated Caronia’s First Amendment rights.
According to experts, the decision does not prevent government regulators from prosecuting companies for failing to present fair and balanced information in promotion.
“While recent First Amendment court decisions have called into question many FDA marketing regulations, the decision in U.S. v. Caronia is likely to be appealed,” reminded John Kamp, Executive Director of the Coalition for Healthcare Communication. “Meanwhile, the FDA rules of OPDP remain in force.”
Federal and State Enforcement—False claims and Anti-Kickback Statutes: Corporate Integrity Agreements and Deferred Prosecution Agreements continue to be announced, some of which have involved settlements of well over a billion dollars.
These agreements contain a number of compliance requirements to ensure that all internal controls and risk-mitigating measures are in place, including requirements for employee training, testing and follow-up.
State Marketing Enforcement Under False Claims Acts: Many states use their own false claims statutes to bring suits, often using FDA Warning Letters to demonstrate that marketing materials are false and/or misleading.
Private and Class Action “Failure to Warn” Allegations for Marketing Activities: Product liability lawsuits continue to be filed against drug and device companies, alleging that misleading and insufficient company communications can be held “responsible” for causing injuries.
Responsible Corporate Officer (RCO) Liability: The FDA has signaled its willingness to hold RCOs accountable for regulatory compliance through increased use of prosecutions. This is in response to Congressional queries and continued industry violations. With RCO liability, corporate presidents and CEOs can be convicted and sentenced to imprisonment without having directly participated in—or even known about—a violation. They can be found guilty simply by virtue of their position in the corporation and their responsibility and authority to prevent or address the criminal violation. Some experts believe that marketing managers, sales directors, and others in “responsible relationships” may also be held legally responsible for violations.
OIG/FDA Collaboration: The FDA and officials from the Office of Inspector General (OIG) in Health and Human Services are actively cooperating and having ongoing discussions regarding their concerns about off-label promotion. Warning letters can tip off state regulators who then investigate further. The Agency continues to monitor promotional practices citing a range of violations, including risk minimization, lack of fair balance, and overstated efficacy and/or superiority claims. Top OIG lawyers on pharmaceutical company settlements have predicted that there will be more indictments in 2013. Currently, there are more than several hundred whistleblower cases pending.
Emerging Risks
The Medicare Modernization Act added drugs to Medicare through Part D, making the government the biggest payer of prescriptions. This intensifies government scrutiny of fraud and brings into play the False Claims Act.
The FDA Amendments Act of 2007 (FDAAA) empowered the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs which, in essence, provides the FDA with additional oversight of drug marketing programs.
The Affordable Care Act includes a “stimulus bill” to fund studies on “comparative effectiveness” (CE). This raises the bar for product differentiation, with an impact on managed market acceptance.
