Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it appears that the FDA may have to begin accepting alternative evidence to support truthful and non-misleading promotional claims, according to Douglas Hallward-Driemeier, partner, Appellate and Supreme Court Practice, Ropes & Gray.

As demonstrated by the Amarin v. FDA case, “the focus is and will be on the key threshold questions of what standard applies to determine if a manufacturer’s speech is truthful and non-misleading, and also … of who gets to make this initial determination – the agency, the courts, or the company,” Hallward-Driemeier said at the 2015 Advertising and Promotion Conference of the Food and Drug Law Institute on Oct. 1.

He told conference attendees that FDA’s current position that a promotional claim is false or misleading if it lacks substantial evidence – generally two randomized, controlled clinical trials – “operates precisely like the prior restraint system that the First Amendment forbids.” The point that prior restraint is not allowed under the First Amendment “is relevant to at least one presidential candidate’s – Hillary Clinton’s – recent legislative proposals stating that the FDA should pre-clear all direct-to-consumer ads,” said Coalition for Healthcare Communication Executive Director John Kamp, who added that “Clinton needs to brush up on constitutional law.”

Further, as a result of the recent rulings, the standard for both on-label and off-label claims “that will apply to determine whether speech is truthful and non-misleading is critical,” Hallward-Driemeier predicted.

Several options for this standard include:

• Substantial evidence
• Substantial clinical evidence
• Valid scientific evidence
• Competent and reliable scientific evidence (CARSE)
• Significant scientific agreement
• Adequate evidence
• Evidence sufficient to satisfy the relevant scientific community of the claim’s truth

Hallward-Driemeier suggested that substantial clinical experience “may be a standard that is worth developing further,” because it could “take into account the significant evidence that companies gather about how their products fare when used in the real world.” He also noted that the CARSE standard, which is used by the Federal Trade Commission, “is perhaps the most interesting and plausible as a standard going forward,” because it is more uniform and is applied more generally.

The more flexible CARSE standard “gets away from categorical rules, instead looking to the expertise of professionals in the relevant area, evaluated in an objective manner, using generally accepted procedures in the field,” he said. He asserts that this flexibility “is ultimately required by the First Amendment.”

In his speech Hallward-Driemeier also outlined the situation manufacturers have faced with the FDA regarding their promotional claims during the past 30 years, remarking that the U.S. Supreme Court and other courts – as demonstrated by the Sorrell, Caronia and Amarin decisions – have been increasingly less tolerant in First Amendment cases of government speech limitations, while the FDA has become more and more detailed in its regulation of drug company speech.

The Supreme Court “has clarified that almost all content-based speech restrictions must survive ‘strict scrutiny,’ a standard that requires the government to establish a compelling government interest and that the restriction is narrowly tailored to achieve that interest,” Hallward-Driemeier said. Kamp said that “strict scrutiny is strict in theory, but most often fatal in fact, further limiting FDA’s ability to use speech bans as a regulatory tool.”

Hallward-Driemeier also commented on the lack of judicial oversight in past years due to the complicated FDA interpretation of the Federal Food, Drug & Cosmetic Act and manufacturer reluctance to pursue disputes over that interpretation in court while facing potential criminal charges and exclusion from the Medicare and Medicaid programs. “Without an ongoing dialogue between courts and agency, regulators went in one direction as the law went in another,” he said.

Today, as industry groups continue to seek FDA’s engagement in this issue, there has not been any significant progress. However, with the rulings against the FDA’s status quo stacking up, change may be forthcoming, Hallward-Driemeier asserted. “One would hope that the agency and industry can now work together to help align the regulatory framework with First Amendment values.”

Read the full text of the Hallward-Driemeier Speech to FDLI.