FDA targets misleading drug ads, non-opioid pain meds in new policies

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Prescription drug advertising and non-opioid pain medicine are targets of two new changes in drug policies announced by the U.S. Department of Health and Human Services (HHS).

The Food and Drug Administration (FDA) has announced a crackdown on deceptive direct-to-consumer pharmaceutical ads, with approximately 100 cease-and-desist letters issued to companies with allegedly misleading ads.

“Pharmaceutical ads hooked this country on prescription drugs,” HHS Secretary Robert F. Kennedy, Jr. said in a news release. “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 overmedicalization that drives America’s chronic disease epidemic.”

Meanwhile, FDA also has issued draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain.” It will “accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid misuse,” according to the administration’s official announcement.

“America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain,” FDA Commissioner Marty Makary, MD, MPH, said in a news release. “FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain.”

‘Ask your doctor…’

FDA’s announcement said the agency’s leadership is concerned patients are not seeing a fair balance of information about drug products. There may be serious risks not clearly presented or with information that is too difficult for seniors to read or hear.

FDA has permitted misleading adverts that distort the doctor-patient relationship. The ad also increase demand, regardless of clinical appropriateness, Makary said.

The ads aren’t cheap, with the top 10 pharmaceutical companies spending a combined $13.8 billion on ads in 2023. Big Pharma makers spend up to 25% of their budget on advertising, according to FDA. “Those billions of dollars would be better spent on lowering drug prices for everyday Americans,” Makary said.

The ads also are not all traditional print explanations or television commercials. In the era of social media, patients may find it difficult to distinguish between claims backed by evidence and those made for promotional purposes, according to FDA. Pharmaceutical manufacturers may use undisclosed paid influencers to promote their products, but that blurs distinctions between editorial content, user-generated media and pharmaceutical advertising.

The FDA announcement cited a 2024 review in the Journal of Pharmaceutical Health Services Research that revealed 100% of pharmaceutical social media posts highlight drug benefits, but only 33% mention potential harms. Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.

In recent years, the FDA’s warning letters have waned in numbers, with none issued in 2024. That changes now, Makary said, and FDA will use artificial intelligence to keep tabs on drug ads.

With the announcement, FDA published this fact sheet and President Donald J. Trump’s policy memo about pharma advertising.

Non-opioid pain medicines

FDA also is opening a 60-day public comment period, scheduled to start Sept. 11, on the new draft guidance, “Development of Non-Opioid Analgesics for Chronic Pain.”

Opioid prescription has declined in the United States in recent years, although the drugs still are used to treat approximately one in five adults who live with chronic pain, according to FDA.

The new guidance emphasizes meaningful outcomes — specifically, reducing the need for opioid use — through efficient drug development, attention to trial design, and appropriate patient populations. FDA’s broader strategy to address the opioid crisis includes:

• Requiring safety labeling changes for opioid pain drugs (e.g., OxyContin) to better reflect current evidence
• Enhancing enforcement around the importation and sale of illegal opioid products
• Facilitating the development of non-opioid alternatives.

The FDA is encouraging the public to comment on this draft guidance. Stakeholders have 60 days from the date of publication in the Federal Register to submit feedback electronically at www.regulations.gov or in writing to the Dockets Management Staff, referencing FDA-2025-D-0610 in the Federal Register notice.