Americans Oppose Off-label Promotion: Consumer Reports
A new nationally representative poll of more than 1,000 adults by Consumer Reports (CR) reveals that most Americans (84%) do not want companies to be allowed to advertise drugs for a use that has not been approved by FDA. The survey results (XXINSERT LINKXX) were shared at the second day (11/10) of an agency hearing on off-label use communications.
More than three quarters of CR’s survey respondents said that it was “extremely” or “very” important that FDA fully vet the safety and effectiveness of medications for a particular use, CR editor Lisa Gill told then hearing. The majority also said it was highly important to know how well a medication can be expected to work (83%), and that they are told of a medication’s possible side effects or other risks (86%).
Former FDA deputy commissioner and now-associate dean of public health practice and training at Johns Hopkins University Bloomberg School of Public Health Josh Sharfstein said that if off-label advertising restrictions are eased, pharmaceutical companies may seize on the opportunity to legally make claims based on incomplete evidence or poor-quality research. “We risk rolling back the clock to a time when the FDA could act only after people have been harmed,” he said. And, even then, it would be much harder to protect consumers because cases of false or misleading claims would have to be resolved through the legal system. “It would wind up putting decisions about the accuracy of drug advertising claims in the hands of judges, not medical experts,” he said.
Sharfstein said he is also worried that relaxing restrictions on off-label drug advertising will discourage rigorous research. “If you can market a drug off-label for a condition, then why spend all the time and money on testing required to earn FDA approval for that use?” he asked. “Ultimately, that will undermine everyone’s access to safe, effective healthcare.”
On the hearing’s first day, industry shrugged off concerns about relaxing off-label communications, saying it would help advance public health (see story). Pharmaceutical Research and Manufacturers of America (PhRMA) told FDA that as a first step in dealing with off-label information dissemination, FDA should create a clear safe harbor for manufacturer communications concerning new medicines and off-label uses of approved medicines with payers and other population health decision makers.
AdvaMed told the hearing that a “balanced and rational agency policy regarding scientific exchange and importantly a tailored policy for medical devices will further the public health by fostering the full exchange of scientific information to healthcare professionals, payers, and other key stakeholders without diminishing FDA’s regulatory purpose of protecting the public health.” The group said that the “chilling impact” of a one-size-fits-all policy or single factor approach could have a particularly harmful impact on truthful and non-misleading communications about medical devices.
And the Washington Legal Foundation (WLF) said that FDA must play an important role in preventing false and misleading information, but it must also work to ensure patients, physicians and health care companies maintain access to the latest information and most current innovation. To accomplish this, the agency must not encroach on the First Amendment rights of various health care stakeholders. “When reviewing its off-label communication regulations, FDA should be mindful that any speech’s ability to mislead depends significantly on its audience,” WLF said. “Based on a multitude of factors, some audiences are more equipped to parse the subtleties of an academic journal’s recent article or a new scientific study. Doctors and other qualified healthcare professionals are not misled by the same information that might confuse members of the general public, and therefore do not require the same protections. Even when an off-label use described in a commercial targeted at the lay public might be considered misleading, that very same statement when made to a room of doctors might well not be. FDA’s regulations should reflect that fact and allow healthcare companies more latitude to discuss the off-label uses of their products when addressing medical professionals.”