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FDA is moving slowly in liberalizing off-label communications amid outrage over opioid promotion.
Even though Scott Gottlieb challenged FDA restrictions on truthful communications about regulated products as a private commentator on pharma policy, he is taking a more measured approach to expanding off-label promotion as FDA commissioner. A high-level FDA working group is “taking a hard look” at how the First Amendment relates to FDA policy, exploring what the agency can to do to “refresh” and bring more
“clarity” to its regulations, commented chief counsel Rebecca Wood at the DIA advertising and promotion conference in March.
Wood noted that the agency also is reviewing a recently issued -and delayed-new rule on “intended use” of regulated products, which raises important issues on how approved drug labels relate to product use. A final guidance issued in December 2017 clarifies how marketers should clearly and prominently display product names in print, broadcast, and online ads to avoid confusion or deception. This advisory may facilitate FDA efforts to modify current policies that require presentation of long lists of side effects in direct-to-consumer (DTC) broadcast ads, based on agency research indicating that consumers better understand and remember more targeted risk information (see sidebar below). More safe harbors for additional types of promotional speech also are under review. A draft guidance published in January 2017 would permit marketers to present healthcare economic information (HCEI) to payers, formulary committees, and “similar entities” to help these knowledgeable experts make coverage and reimbursement decisions. A notable section further outlines how sponsors may provide payers with advance information on investigational drugs and devices to facilitate early coverage decisions on important pipeline therapies.
Another guidance presents a strategy for marketers to communicate information that is not in the FDA-approved label for a marketed therapy, but is “consistent with” FDA-required labeling, or CFL. Such messages must be truthful and not cause harm, and may be useful in presenting new product comparative information or discussing additional adverse reactions, patient subgroup analysis, or conveniences in product use. Marketers have submitted proposals to OPDP for utilizing this new approach, while seeking further clarification and examples from the agency.
FDA’s deliberative process for liberalizing off-label promotion also reflects the mounting legal attack on pharma sales and advertising practices for feeding the nation’s opioid epidemic. States and municipalities have brought hundreds of lawsuits against opioid manufacturers and distributors for aggressive marketing activities that have spurred inappropriate and excessive prescribing of painkillers. Private plaintiffs’ attorneys and Native American tribes are joining the attack, and the Department of Justice recently said it, too, would seek to recover costs for federal government opioid treatment programs by becoming involved in legal actions.
The plaintiffs allege that manufacturers deceived patients and caused harm by underwriting false, deceptive, or unfair marketing practices, often overstating benefits and downplaying risk of addiction, particularly for extended-release formulations. Prosecutors also are probing company use of speakers’ bureaus to channel funds to high prescribers, as seen in the case brought in March by the US attorney of New York against five physicians for accepting bribes in the form of speaking fees to increase prescriptions of Insys Therapeutics’ fentanyl spray.
Investigations into opioid marketing have raised questions about industry support of medical and patient advocacy groups that promoted broader prescribing of pain medicines. In February, Sen. Claire McCaskill (D-Mo) issued a report on financial ties between opioid makers and distributors and advocacy groups as part of her ongoing investigation into the role of industry sales and marketing in fueling the opioid epidemic. The analysis reported that five firms gave nearly $9 million over five years (2012-2017) to 14 organizations that promoted opioid use for chronic pain, countered claims of addictive risks, and opposed prescribing limits.
Purdue Pharma responded earlier this year by promising to limit marketing activities for opioids, following similar actions by other manufacturers, including Endo, Teva, Allergan, and Johnson & Johnson. Instead of sales reps promoting OxyContin prescribing, Purdue said it will distribute prescribing guidelines prepared by the Centers for Disease Control and Prevention (CDC). Perhaps Purdue hopes to avoid paying millions more in fines, as it has done over the last decade to settle civil and criminal charges related to Oxy marketing. But penalties may mount for all manufacturers as public agencies seek billions to support costly addiction and rehab programs.
Opioid marketing also has drawn rebukes from FDA’s Office of Prescription Drug Promotion (OPDP), which has cited firms for overstating benefits and limiting or omitting critical risk information in promotional materials. A February untitled letter charges Collegium Pharmaceutical for failing to display important risk information about its Xtampza oxycodone extended-release capsules at a trade show booth. Last year, OPDP sent a warning letter to Cipher Pharma for overstating benefits and omitting risk information on its ConZip opioid agonist, despite a boxed warning and specific limitations on product use. Durect Corp. and Pain Therapeutics received letters in September 2016 for using websites to promote an investigational extended-release pain medicine, Remoxy, as safe and effective.
At the beginning of this year, moreover, FDA and the Federal Trade Commission sent joint warnings to 11 companies for producing and distributing dietary supplements and holistic medicines that made unapproved claims for treating opioid addiction or withdrawal symptoms. While OPDP compliance actions have declined in recent years, these warnings illustrate that violative marketing of pain pills and overdose treatments will draw enforcement action.
Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at firstname.lastname@example.org