HHS, FDA drop major DTC advertising policy changes

With the much-anticipated release today of the Make America Healthy Again report and strategy document, the US Department of Health and Human Services under Robert F Kennedy Jr also announced a new policy change that would require pharma companies to list drug information much more extensively in broadcast advertisements.

"Pharmaceutical ads hooked this country on prescription drugs," Kennedy said in a statement. "We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalisation that drives America's chronic disease epidemic."

The new push for DTC advertising reform builds on a section of the MAHA report titled “The Overmedicalisation of Our Kids”, which alleges that Americans, especially children, are overprescribed medications including ADHD medicines, antidepressants, antipsychotics, antibiotics, and even asthma inhalers. The section also calls into question the safety and necessity of many childhood vaccines.

Reverting policy, closing loopholes, and stepping up enforcement

Specifically, the FDA is initiating a rulemaking process to rescind changes it made in 1997 that allowed pharma companies to limit the aired disclaimer to a “major risk statement” and direct consumers to a website, toll-free number, or printed insert for more information.

“The FDA has historically stipulated that a manufacturer, packer, or distributor must provide the public with materially complete information that fairly balances both the benefits and the risks of the drug,” President Donald Trump wrote in a memorandum timed with the announcement. “Over time, however, the FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising, and drug manufacturer advertising has skyrocketed in recent decades. My Administration will ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.”

The agency also announced that it would begin “aggressive enforcement” of DTC advertising violations and close “digital loopholes” by expanding oversight into social media ads, AI-generated health content and chatbot interactions, influencer partnerships, and sponsored content.

Aggressive enforcement will involve sending letters to thousands of pharma companies “warning them that the Agency is no longer asleep at the wheel” and issuing dozens of enforcement letters related to false or misleading advertising.

A soft ban on DTC?

By introducing more onerous requirements without attempting an outright ban on DTC advertising, HHS seems to be attempting to sidestep an inevitable first amendment argument from pharma.

“The action simply returns to the status quo policy pre-1997,” the FDA wrote in its fact sheet about the change. “It requires the presentation of factual and uncontroversial statements, which are already legally required to be communicated in drug advertising; goes directly to the core government interests of protecting the public from deception and protecting public health - as supported by voluminous evidence of public harm under the current system; and does not unduly burden advertisers, by preserving their right to engage in commercial speech under the standards that existed prior to 1997.”

Jim Potter, the executive director for the Coalition for Healthcare Communication, is cautiously optimistic about today's announcement.

"Misleading DTC Rx advertising is the cornerstone of FDA law and regulations, which the healthcare marketing industry wholly supports," he told pharmaphorum in an email. "And it is a far cry from the clearly unconstitutional threats and proposals to ban all DTC and HCP prescription drug marketing in the United States."

Potter added that, if FDA actions violate the Administrative Procedures Act, many in the industry are likely to sue.

"However, if it advances helping provide balanced information to consumers and caregivers within the 'clear, conspicuous, and neutral' (CCN) ruling issued in 2023, then we can look forward to working with the FDA," he wrote. "Ultimately, our mutual goal is to help patients be better informed and better engage with their healthcare providers in joint decision-making for improved health outcomes. "

Responding to the MAHA report broadly, the Pharmaceutical Research and Manufacturers of America (PhRMA) questioned the premise of the government’s action.

“The idea that children are broadly overprescribed mental health medications is misleading; in fact, because of poor reimbursement for mental health providers and restrictions by health plans, many patients with mental illness often do not receive professional help for their symptoms and remain undiagnosed and untreated,” the Association wrote.

“DTC advertising provides patients with important fact-based, useful, and accessible information about potential treatment options,” they added. “PhRMA’s member companies are committed to responsible, accurate advertising that helps Americans make informed decisions about their healthcare in consultation with their doctor.”