Rx Enforcement In 2025: Shift Away From Opioid Makers But Tougher Approach On Ad/Promo

Drug and biologic product-related enforcement is expected to remain strong during the next Trump Administration, although the focus could shift compared to the Biden Administration.

Imported ingredients and products, good manufacturing practices, especially for vaccines, and drug advertising and promotion could face heightened enforcement by the new administration. And as legal cases against prescription opioid manufacturers wind down, prosecutors could turn to companies whose products are being diverted to make illicit drugs.

Compounding pharmacies also may face less enforcement, given the industry’s ties to Martin Makary, President-elect Donald Trump’s announced candidate for FDA commissioner.

Several panels of legal, industry, political and government experts offered predictions for FDA-related product enforcement trends in 2025 during the Food and Drug Law Institute’s recent Enforcement, Litigation and Compliance Conference.

Nonpartisan Enforcement Priorities

Representatives from the FDA and other consumer protection agencies said enforcement efforts will continue focusing on public health and consumer safety in the coming year, issues that are nonpartisan.

Shannon Singleton, FDA deputy chief counsel for litigation (enforcement), said she has seen about six presidential elections since she joined the chief counsel’s office.

“The reality is that the lion’s share of what we do doesn’t change,” Singleton said. “We’re protecting the safety of American citizens, period. And so with that in mind, it’s not a partisan issue.”

“I remain optimistic that our enforcement will not change that drastically,” she added. “It shouldn’t.”

“The reality is that the lion’s share of what we do doesn’t change. We’re protecting the safety of American citizens, period. And so with that in mind, it’s not a partisan issue.”

FDA’s Shannon Singleton

Serena Viswanathan, associate director of the Federal Trade Commission’s Bureau of Consumer Protection, highlighted the commission’s work related to artificial intelligence, product reviews, online safety of children and teens, and consumer privacy issues during the past year.

“These aren’t really partisan issues,” Viswanathan said. “And a lot of these matters, we are able to get all five commissioners, or however many there are at any one time voting for these matters.”

“Consumer protection doesn’t change that much,” she added. “The specifics of what kinds of cases you’ll bring with respect to these priorities might change a little bit, but I expect us to continue to be busy in the next year.”

Similarly, Mary Riordan, senior counsel at the Health and Human Services Department’s Office of the Inspector General, said much of her group’s work is focused on ensuring Medicare and Medicaid program financial integrity and improving outcomes.

“I don’t foresee that a lot of our enforcement priorities or other priorities are going to change dramatically,” Riordan said. “Never say never, but that’s my prediction right now.”

What’s Next After Opioids?

Former government officials and industry lawyers expect some changes in enforcement focus with the incoming Republican administration.

Gustav Eyler, a partner at Gibson Dunn and Crutcher in Washington DC and former director of the Justice Department’s Consumer Protection Branch, said that while DoJ dedicated a large amount of resources to cases involving prescription opioid manufacturers, many have settled or are likely to end during the new administration.

Among the recent settlements was Endo Health Solutions, which in May was ordered to pay $1.09bn in criminal fines and $450m in criminal forfeiture for violations of the Food, Drug and Cosmetic Act related to distribution of the long-acting opioid Opana ER (oxymorphone). The case resulted in the second largest set of criminal penalties ever levied against a pharmaceutical company, DoJ said.

“We know the new administration is skeptical, for instance, about vaccine development, so you may see more of an emphasis on GMP type issues in development of these products.”

Holland and Knight’s John Vaughan

Endo also agreed to pay $475.6m to resolve its civil liability under the False Claims Act.

DoJ recently announced that consulting firm McKinsey & Co. agreed to pay $650m to resolve a civil and criminal investigation into its consulting work with Purdue Pharma. The settlement related to McKinsey’s advice to Purdue about sales and marketing of its extended-release opioid drug OxyContin (oxycodone).

The agreement marked the first time a management consulting firm has been held criminally responsible for advice resulting in the commission of a crime by a client, DoJ said.

On 18 December, the department announced a new opioid-related action against a nonmanufacturer.

In a civil a complaint, the government alleged CVS Pharmacy filled unlawful prescriptions, including for excessive quantities of opioids, in violation of the Controlled Substances Act, and sought federal healthcare program reimbursement in violation of the False Claims Act.

With many of the traditional opioid defendants now having settled, DoJ has begun targeting corporations whose products, chemicals or equipment allegedly are being diverted to make illicit drugs, Eyler said. A key question is whether companies knew, or should have known, their products were being diverted for that purpose.

Eyler said companies should take a closer look at their customers.

“If we have some idea that things may be misused, the government, with their experience and their criminal tools, may be thinking about how can we continue to fight this fight in different ways?” he said.

Eyler also predicted there would be an increased enforcement focus on online marketplaces, imported food and drug products and ingredients, and Good Manufacturing Practice quality standards.

“We know the new administration is skeptical, for instance, about vaccine development, so you may see more of an emphasis on GMP type issues in development of these products,” said John Vaughan, a partner at Holland and Knight in Los Angeles. “I think it’s more of a question of the focus of the regulations, rather than it’s more or less regulation.”

The FDA on 10 December announced five warning letters had been sent to online marketplaces for introducing unapproved GLP-1s, including semaglutide, tirzepatide and retatrutide products, into interstate commerce. One letter also asserted a firm had misbranded its products by claiming they were FDA-approved.

Pendulum Swings Between DTC ...

The amount and type of drug enforcement in the second Trump Administration will depend, in part, on the influence of those outside of the FDA, including DoJ and the Health and Human Services secretary.

Trump has tapped Robert F. Kennedy Jr., a vocal critic of vaccines and direct-to-consumer advertising, for the HHS post.

Although DTC advertising is unlikely to be banned, lawyers and former FDA officials expect closer scrutiny in the coming year, with a continued focus on efficacy claims.

Almost all of the Office of Prescription Drug Promotion’s untitled letters in the past year-and-a-half have cited unsupported efficacy claims.

“If you look at the trajectory the agency has been going on for this enforcement around ad/ promo, it’s really been focused on digging very deeply into the data and saying it’s substantiated,” said Jacqueline Berman, a partner at Morgan, Lewis and Bockius in Washington DC. “I think we’ll continue to see that in more traditional promotional enforcement and I think we’ll see that in the DTC space, especially with some statements that can be made in DTC ads just to make them consumer friendly.”

Effective 20 November, DTC TV/radio ads must comply with the FDA’s regulation on “clear, conspicuous and neutral” presentation of the major statement of side effects.

“I would expect, in a linear world, to see some enforcement next year against those ads that do not comply,” said Wayne Pines, president of healthcare at APCO Worldwide.

... And Compounding

While enforcement is expected to increase in the ad/promo space, it may decrease for compounded drugs.

Makary, the Johns Hopkins surgeon tapped by Trump to lead the FDA, has ties to a telemedicine company that helps patients access compounded GLP-1 agonists and a firm that produces compounded ophthalmology products.

“I don’t know how that plays out, except that it’s a huge, huge problem and I can see under Makary ... potentially there’s less enforcement against compounders,” said Kalah Auchincloss, a principal at Eliquent Life Sciences. “Then you have this sort of … side business or side hustle where you don’t even have FDA-approved drugs, you have compounded drugs.”