By Zachary Stieber
Federal officials are resuming enforcement of regulations that dictate how pharmaceutical products can be advertised to consumers, the Trump administration said on Sept. 9, as President Donald Trump signed a new executive order.
The Food and Drug Administration (FDA) is restarting its enforcement of regulations that prohibit pharmaceutical ads from creating a “misleading impression” and require them to present a “fair balance of information,” a senior administration official told reporters on a call.
The FDA is also reversing its 1997 relaxation of direct-to-consumer ad regulations, which enabled companies to point people to information hosted in other places, such as websites, the official said. Spending on direct-to-consumer ads jumped from $150 million in 1993 to $6 billion in 2016, according to a 2023 paper published in the Journal of Public Economics. The rise primarily happened after the 1997 FDA move.
“Our goal is to ensure that patients have proper information about drugs that have potential harms, and it’s to rebuild public trust,” the official said.
“This presidential memorandum is the strongest, boldest action that we can take on making sure that people have patients have adequate safety information on pharmaceutical ads,” another senior administration official told reporters on the call. “There’s no additional steps planned.”
A bipartisan group of senators is pursuing legislative action to eliminate direct-to-consumer ads.
FDA regulations require ads to present “a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug” and prohibit creating a “misleading impression.”
The FDA has increasingly declined to enforce the regulations. While in the past the agency would regularly send more than 100 enforcement letters to companies each year, just one was sent in 2023, and none were sent in 2024, according to the administration.
The FDA was going to send out about 100 of these cease-and-desist letters on Tuesday, an administration official said. The official declined to identify any of the companies or commit to releasing the letter.
The administration was alerted to the issue by senators who flagged an ad during the Super Bowl in January from Him and Hers that advertised weight-loss pills and did not mention any possible side effects.
The company did not immediately respond to a request for comment.
Asked about whether the FDA has stopped enforcing the regulations due to lawsuits, an administration official said that “there are ads that are clearly crossing the line with respect to the regulation, making any potential future legal action, I think, pretty clear-cut.”
“We are also going to be looking hard at social media companies, social media influencers … that have influencers paid to promote pharmaceutical products without proper disclosures and without following the same rules that pharmaceutical companies follow,” an administration official said.
According to a 2024 review of previous studies and articles, some pharmaceutical companies and individuals have increasingly used social media to promote drugs, and only about a third of posts mentioned possible harms from the promoted drugs.
Federal officials said in a report released on Thursday that the FDA, the Department of Justice, and other agencies would “increase oversight and enforcement under current authorities for violations of direct-to-consumer (DTC) prescription drug advertising laws.”
Officials are going to focus on “egregious violations demonstrating harm from current practices,” including those from social media influencers, they said.
![The U.S. Food and Drug Administration (FDA) is refusing to release the results of autopsies conducted on people who died after getting COVID-19 vaccines. The FDA says it is barred from releasing medical files, but a drug safety advocate says that it could release the autopsies with personal information redacted. The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reported obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination. Reports are lodged with the system when a person experiences an adverse event, or a health issue, after receiving a vaccine. The FDA and other agencies are tasked with investigating the reports. Authorities request and review medical records to vet the reports, including autopsies. The FDA declined to release any reports, even redacted copies. The FDA cited federal law, which enables agencies to withhold information if the agency “reasonably foresees that disclosure would harm an interest protected by an exemption,” with the exemption being “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.” Federal regulations also bar the release of “personnel, medical and similar files the disclosure of which constitutes a clearly unwarranted invasion of personal privacy.” The Epoch Times has appealed the denial, in addition to the recent denial of results of data analysis of VAERS reports. ‘Easily Be Redacted’ Kim Witczak, a drug safety advocate who advises the FDA as part of the Psychopharmacologic Drugs Advisory Committee, said that the reports could be released with personal information blacked out. “The personal information could easily be redacted without losing the potential learnings from [the] autopsy,” Witczak told The Epoch Times via email. People make the choice to submit autopsy results to the Vaccine Adverse Event Reporting System, Witczak noted. “If someone submits their experience to VAERS they want and expect to have it investigated by the FDA. This includes autopsy reports,” she said. Autopsies are examinations of deceased persons performed to determine the cause of death. “Autopsies can be an important part of postmortem analysis and should be done especially with increased deaths following COVID-19 vaccination,” Witczak said. FDA Responds An FDA spokesperson noted that deaths following COVID-19 vaccination are rare, citing the number of reports made to VAERS. As of Sept. 14, 16,516 reports of death following COVID-19 vaccination have been reported. Approximately 616 million doses have been administered in the United States through September. The spokesperson declined to say whether the FDA would ever release the autopsy results, but pointed to a paper authored by researchers with the FDA and the Centers for Disease Control and Prevention (CDC). The paper, which has not been peer reviewed, analyzed the approximately 9,800 reports of death to VAERS following COVID-19 vaccination lodged from Dec. 14, 2020, to Nov. 17, 2021. Researchers found that reporting rates were lower than the expected all-cause mortality rates. “Trends in reporting rates reflected known trends in background mortality rates. These findings do not suggest an association between vaccination and overall increased mortality,” the researchers wrote. The researchers noted that prior studies have found that adverse events reported to VAERS are an undercount of the true number of events.](https://www.usnn.news/wp-content/uploads/2022/09/FDA-Withholding-Autopsy-Results-on-People-Who-Died-After-Getting-COVID-19-Vaccines-150x150.jpg "FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines | USNN World News")
