Senate bill aims to curtail social media influencer, telehealth drug misinformation
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Key takeaways:
- The Protecting Patients from Deceptive Drug Ads Online Act was introduced in the U.S. Senate on Sept. 12.
- The bill looks to limit false information about prescription drugs on social media.
A recently proposed U.S. Senate bill aims to crack down on social media influencers and others online who make misleading comments about pharmaceutical drugs.
On Sept. 12, Sen. Dick Durbin, D-Ill., and Sen. Mike Braun, R-Ind., introduced S.5040, titled the Protecting Patients from Deceptive Drug Ads Online Act. According to a press release from the co-sponsoring senators, the goal of the legislation is to extend the FDA’s purview over drug advertising. The bill would allow the FDA to issue warning letters and potential fines to social media influencers and telehealth companies who promote prescription drugs using false information or withholding important information about labeling, adverse events and more.
“The power of social media and the deluge of false and misleading promotions has meant too many young people are exposed to inaccurate and harmful advice that promises quick fixes from certain medications,” Durbin said in a press release. “And when an influencer or telehealth company is communicating for commercial gain and sharing deceptive medical content, this can place consumers at risk of severe and long-lasting side effects. Our bipartisan legislation would close loopholes that are exploited online by empowering FDA to protect patients from prescription drug advertisements lacking basic safety and accuracy information.”
“We need transparency in every part of the health care industry so Americans can make informed decisions about their health. If a company is making misleading claims about their drugs, that can have serious consequences on the health, safety and well-being of Americans,” Braun said in a press release.
The bill would cover all prescription medications, but semaglutide (Ozempic/Wegovy, Novo Nordisk) was the one drug mentioned in a one-page brief about the bill released by Durbin and Braun’s offices. The brief stated patients could be at risk for severe adverse events due to “well-documented instances of deceptive or misleading promotion include communications by influencers recommending drugs like Ozempic for unapproved, off-label purposes, and touting the benefits of the drug to create the impression that others can achieve similar results.”
Sangeeta R. Kashyap, MD, assistant chief of clinical affairs in the division of endocrinology, diabetes and metabolism at NewYork-Presbyterian/Weill Cornell Medical Center and a Healio | Endocrine Today Co-editor, said she believes that pharmaceutical advertising is important because it encourages patients who may be indicated for a medication to speak to their provider about it. However, she added that advertisements need to be truthful about medications and should not push patients to acquire the drug without first speaking with their provider.
“The decision to prescribe a chronic medication needs to be between the patient and physician,” Kashyap told Healio. “Deceptive ads may add to the mistrust between medical providers and patients.”
The bill also requires payments made by pharmaceutical companies to social media influencers to be publicly reported. Katherine H. Saunders, MD, DABOM, co-founder of FlyteHealth and obesity physician at Weill Cornell Medicine, said this requirement is important for helping people better understand why someone may be promoting a medication on their social media page.
“Our patients are extremely vulnerable,” Saunders told Healio. “Most of them have tried countless treatment strategies over the years, and many are desperate to find an effective, long-term solution.”
Misinformation about obesity medications is not a new problem, but it remains a serious one, according to Caroline M. Apovian, MD, co-director of the Center for Weight Management and Wellness in the division of endocrinology, diabetes and hypertension at Brigham and Women’s Hospital and a Healio | Endocrine Today Editorial Board Member. Apovian said online influencers and companies have advertised semaglutide, tirzepatide (Mounjaro/Zepbound, Eli Lilly) and similar medications as merely weight-loss drugs. Apovian said this undermines obesity treatment, which goes beyond just medication.
“Obesity is a serious disease that is afflicting 40% of Americans and 1 billion people worldwide,” Apovian told Healio. “It’s not a cosmetic problem. It leads to a lot of death and a lot of other medical problems that lead to death.”
Combating online misinformation
Apovian and Saunders both said they believe that the FDA approval of semaglutide and tirzepatide helped lead to the surge of online misinformation about obesity drugs. Apovian said the approval of the medications has put pressure on companies advertising non-FDA approved weight-loss supplements such as berberine, which is commonly advertised as “nature’s Ozempic.”
“The [weight-loss supplement] industry is slowly going away because of these [obesity] medications,” Apovian said. “They’re desperately trying to get back into the game.”
Misinformation on obesity medications comes from different forms, according to Saunders. She said some sources will overhype the medications, leading to people who may not be candidates for the drugs to ask for them.
“While GLP-1 receptor agonists are life-changing medications for carefully selected patients when prescribed appropriately with tons of education and support, not every patient needs a GLP-1,” Saunders said.
The first part of the proposed bill specifically aims at social media influencers or health care providers who make “false or misleading communications” about an FDA-approved medication. The bill defines false and misleading communications as an advertisement or promotional communication made on social media where the person speaking is receiving a financial benefit and “knowingly or recklessly” makes a comment with false or inaccurate statements or omission of fact regarding a drug’s adverse events, efficacy or indications. The bill would make social media advertisements about drugs subject to the same regulations in section 502(n) of the Federal Food, Drug and Cosmetic Act that governs direct-to-consumer drug advertising.
Kashyap said requiring transparency for any type of prescription drug advertising is critical for providers to maintain a strong relationship with their patients.
“Ads that are not transparent with respect to cost, side effects and efficacy will lead to mistrust between patients and their doctors,” Kashyap said.
Telehealth and misinformation
The bill goes beyond just individual social media influencers. Any telehealth company that “offers to bring together a potential patient and a prescriber or dispenser through use of electronic information and telecommunication technologies to engage in prescribing or dispensing of any drug subject to section 503(b)(1),” would also be required to provide accurate and truthful information about any prescription drugs they advertise.
Saunders said this part of the bill is important because patients may not be able to tell the difference between a telehealth provider practicing evidence-based care and another that may be prescribing obesity medications without taking the steps necessary to make sure medical therapy is right for the patient.
“Effective and long-term medical obesity treatment requires medical expertise and a relationship with a care team that provides tons of education, close monitoring, support and fine-tuning of medications,” Saunders said.
When treating people with obesity via telehealth, Saunders said it is ideal to have a multidisciplinary care team with experienced clinicians who provide evidence-based treatment that aligns with obesity guidelines. Saunders added that for the most effective, safe, long-term, patient-centered obesity treatment, a telehealth company should provide synchronous care, require laboratory draws before starting pharmacotherapy, and consider use of all FDA-approved medications beyond semaglutide and tirzepatide.
New disclosure regulations
The bill would also require the disclosure of payments made by pharmaceutical companies to telehealth companies or social media influencers, or payments made by a telehealth organization or provider to a social media influencer. Kashyap agreed that any payments made to a person or company advertising pharmaceutical drugs should be made public.
“Transparency for disclosure for payments to influencers is needed to maintain fairness and equity for consumers,” Kashyap said. “Consumers need to know that these are marketing tactics to sell their drugs.”
Apovian agreed with Kashyap, but admitted she is unsure whether the requirement will have an impact on patients.
“Most people who go and deal with influencers already know they’re not going through a reputable doctor, they may not care,” Apovian said. “But it is helpful to know that the person that you’re believing is making a lot of money from selling this product. That would be make you think twice.”
Moving forward
Several medical associations were listed as endorsers for the new bill, according to a one-page brief about the bill released by Durbin and Braun’s offices. In a letter written to the two co-sponsors on Aug. 28, Isaac O. Opole, MD, PhD, MACP, president of the American College of Physicians, said the organization supports the Protecting Patients from Deceptive Drug Ads Online Act and stated the bill is consistent with the group’s policy on prescription drug advertising.
“American College of Physicians believes that direct-to-consumer advertising of prescription drugs is an inappropriate practice that undermines the patient-physician relationship and often leaves patients confused and misinformed about medications,” Opole wrote in the letter. “Since direct-to-consumer advertising is increasing and in the absence of legislation or regulation to ban direct-to-consumer advertising, the FDA should play a stronger role in ensuring that complete, valid and clear information is provided to the public and in making determinations about whether the commercial information in a direct-to-consumer ad actually will educate and enhance the health of the public.”
Other organizations listed as endorsers of the bill include the American Academy of Neurology, American Academy of Family Physicians, American Academy of Child and Adolescent Psychiatrists and the American College of Gastroenterology. After being introduced on Sept. 12, the bill was sent to the Senate Committee on Health, Education, Labor and Pensions.
Apovian said she believes that the proposed bill could help combat prescription drug misinformation online if it is passed, but she also believes misinformation regarding obesity drugs will decrease if the cost of the medications drops and access improves.
“It’s going to happen naturally as the drugs that have made it on the market, that are powerful, are finally getting in patients’ hands with a doctor’s prescription,” Apovian said.
Saunders said she is hopeful that the legislation will deter misinformation online and also be a reminder for people with obesity of the importance of having a dedicated provider and care team that practice evidence-based medicine.
“This is a relationship-based situation,” Saunders said. “Our patients all hit bumps in the road. Obesity is complex and lifelong. People need to feel comfortable reaching out to their provider to partner with them nonjudgmentally against the twists and turns, which are an expected part of their tricky disease.”
References:
- ACP letter of support for protecting patients from deceptive drug ads online. https://www.acponline.org/sites/default/files/acp-policy-library/letters/acp_letter_of_support_for_protecting_patients_from_deceptive_drug_ads_online_act_2024.pdf. Published Aug. 28, 2024. Accessed Sept. 25, 2024.
- Congress.gov. S.5040. https://www.congress.gov/bill/118th-congress/senate-bill/5040. Published Sept. 14, 2024. Accessed Sept. 25, 2024.
- Durbin, Braun introduce Protecting Patients From Deceptive Drug Ads Online Act. https://www.durbin.senate.gov/newsroom/press-releases/durbin-braun-introduce-protecting-patients-from-deceptive-drug-ads-online-act. Published Sept. 12, 2024. Accessed Sept. 25, 2024.
- Protecting Patients from Deceptive Drug Ads Online Act. https://www.durbin.senate.gov/imo/media/doc/Durbin-Braun_Deceptive%20Social%20Media%20Rx%20Promotion.pdf. Published Sept. 12, 2024. Accessed Sept. 25, 2024.
For more information:
Caroline M. Apovian, MD, can be reached at capovian@mgb.org; X (Twitter): @MarsApovian.
Sangeeta R. Kashyap, MD, can be reached at srk4008@med.cornell.edu.
Katherine H. Saunders, MD, DABOM, can be reached at katherine@flytehealth.com.
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