FDA Extends Comment Period on Off-label Info Review
FDA has extended until 4/10/2017 the comment period on its initiative to review “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” FDA says the comments will inform policy development in this area — something the agency has been uncomfortable with for a long time in the wake of court defeats, and now also something that the new time extension gives the Trump Administration a better opportunity to influence.
The agency held a public hearing last month to obtain stakeholder comments (see earlier story). Pharmaceutical Research and Manufacturers of America (PhRMA) said 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, “a highly sophisticated segment of the health care system, and one with a particular economic interest to be discerning in its review of information.” A second step, according to PhRMA, “would involve the creation of a clear safe harbor regarding the communication to health care professionals of real world evidence — evidence based on actual patient use of approved medicines in medical practice – as well as other clinical trial information about patient treatment options. A third step would involve the creation of a safe harbor to protect communication to health care professionals regarding medically accepted unapproved uses of FDA-approved medicines, including in particular, uses recognized by national medical associations and compendia services.”
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 told the agency 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.
On the hearing’s second day, a new nationally representative poll of more than 1,000 adults by Consumer Reports (CR) revealed that most Americans (84%) do not want companies to be allowed to advertise drugs for a use that has not been approved by FDA. 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 the 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.”
Meanwhile, transcripts of the public hearing have been posted and can be viewed below: