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Agency leaders go slow in weighing changes to DTC ads and off-label marketing.
FDA regulation of prescription drug and medical product promotion has come under fire in recent years, as federal courts have supported industry challenges to rules limiting communications of unapproved drug uses. But with little to show from two years of meetings and discussions about reconciling long-held promotion restrictions with legal decisions favoring greater protection of commercial speech, the arrival of
Scott Gottlieb to helm the agency has raised expectations that a more flexible policy will emerge. While marketers maintain they can provide truthful information on drug uses without undermining product safety, no one expects radical change in the current political climate.
The deadly opioid epidemic, moreover, has prompted more intense examination of the role of drug marketing in encouraging excess prescribing of these dangerous medicines. Multiple states and local governments have filed suits against manufacturers for encouraging opioid overuse and abuse, and FDA’s Office of Prescription Drug Promotion (OPDP) has issued enforcement letters citing violative promotion of pain medicines. Most recent is a warning to Cipher Pharmaceuticals for minimizing risk information in professional materials on combination extended release pain therapy ConZip. Another cites Pain Therapeutics and DURECT Corp. for touting its investigational opioid therapy Remoxy ER on its website, prior to approval.
The HHS inspector general (OIG) is scrutinizing how pharma marketing programs encourage such overprescribing, with an eye out for evidence of doctors receiving kickbacks from manufacturers, noted OIG senior counsel Mary Riordan at the advertising and promotion conference in September sponsored by the Food and Drug Law Institute (FDLI). The Justice Department recently collected more than $7 million from Galena Biopharma to settle allegations that the company paid kickbacks to doctors to boost prescriptions for pain drug Abstral, and the investigators are scrutinizing other cases (see sidebar below).
Just before the new administration took over in January, FDA issued a memorandum that largely defends agency restrictions on off-label communications. It also published a final rule that changed the definition of “intended use” of regulated products, prompting an outcry from industry that it requires manufacturers to revise labeling for additional uses even when the firm does not support that off-label use.
At the same time, FDA published two new draft guidances that set the stage for more flexible communications with payers and formulary committees on pricing issues and for permitting certain “out-of-label” communications that are “consistent with” FDA-required labeling (CFL). And in March, FDA
delayed implementation of the controversial “intended use” rule for a year (until March 2018) and began the process of clarifying and finalizing the new guidances.
OPDP analysts sought to explain the intent and recommendations of the CFL guidance at the FDLI conference, as marketer comments on the proposal indicate a need for clearer examples of what is CFL and recommended disclosure strategies. FDA says it will permit communication of unapproved uses that provides truthful and non-misleading information on approved products and presents no harm to patients. CFL information may address the product’s indication, intended population, dosing and directions for use and should be presented in an “appropriate context,” with clear presentation of study results, claims, and limitations on data. OPDP staffers say they’re ready to advise marketers on whether proposed promotional materials meet the new standard or imply new intended uses.
The new draft guidance on manufacturer communications with payers, formulary committees, and similar entities implements a provision in the 21st Century Cures legislation by outlining appropriate presentation of healthcare economic information (HCEI) on approved drugs. More surprising is a second section that describes a process for presenting similar information to payers regarding investigational drugs and devices prior to agency approval. The guidance aims to clarify what information qualifies as HCEI, who can deliver the information, and what type of claims fall outside this policy.
If FDA is going to make notable changes in promotion policy, it may start by revising the scope and format of risk information presented in DTC advertising. FDA is examining evidence that limiting warnings in TV commercials to severe, serious, or actionable side effects might be more informative than lengthy laundry lists of potential adverse events. The change reflects research indicating that more targeted presentation of risks actually may help consumers weigh potential side effects (see here).
Such a change is supported by OPDP analysis indicating that consumers may retain more risk information from targeted statements. A separate study by researchers at the London Business School found that consumers regard drugs as less risky when drug ads list all its side effects, and that they better understand warnings and side effects when only the most serious risks are presented.
Similarly, another OPDP study raises questions about the value of requiring disclosures about limitations on comparative price information in DTC and professional print ads because most consumers and physicians fail to notice or understand such caveats, even when prominently displayed. The analysts also are examining how larger size and clearer presentation of text running in TV commercials may be better understood and remembered by viewers; if animated TV ads improve understanding of risk information; and changes in
DTC ad design for older and hearing impaired audiences.
OPDP has a long research agenda, which has drawn complaints from industry that many of its projects are redundant and not useful. But Gottlieb pointed to “FDA’s own research on broadcast TV advertisements” in his comments posted in August suggesting that a more targeted method for delivering risk information “may lead to better retention of those risks.” If the commissioner is going to alter TV commercial formats, he wants strong evidence that benefits clearly outweigh risks. As FDA officials move forward on DTC revisions and finalizing the two new draft guidances, they also will be reviewing the continuing debate over how marketers can respond to unsolicited requests and discuss scientific information. But there won’t be any change in the basic requirement that all communications are truthful and not misleading, always.
Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at email@example.com