Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Senator Dick Durbin (D-IL) expressed concerns over the agency’s ability to regulate direct-to-consumer (“DTC”) prescription drug advertisements following recent workforce reductions.  In his letter, Senator Durbin highlighted FDA’s critical role in ensuring that pharmaceutical advertisements are truthful, not misleading, and provide balanced information and asked a number of questions including those pertaining to the Office of Prescription Drug Promotion’s (“OPDP”) current leadership, the number of employees that lost jobs due to Reductions in Force (“RIF”), and the impact the RIF will have on OPDP’s future activities.

We at HPM have also been wondering about the future of prescription drug promotion and what actions this administration may take on DTC prescription drug ads specifically, especially in light of comments from the U.S. Department of Health and Human Services Secretary, Robert F. Kennedy Jr., stating that he would advise President Trump to ban pharmaceutical advertising on TV.  Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesn’t “have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture.”  DTC prescription drug ads have also been an area of focus for Congress, with a recent proposal to eliminate tax deductions for expenses related to DTC advertising of Rx drugs.

In 2021, the U.S. Government Accountability Office (“GAO”) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials.  Senator Durbin’s letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have “low therapeutic value.”  This raises concerns about the impact of such advertising on public health and taxpayer dollars, especially considering that prescription drugs advertised on television accounted for 58% of Medicare’s overall spending on prescription drugs between 2016 and 2018, according to the 2021 GAO report.

Durbin’s letter addresses FDA’s capacity to oversee the increasing volume of DTC advertisements, particularly on platforms like social media.  He emphasized the need for FDA to modernize its regulatory approach to keep pace with evolving advertising practices and ensure that consumers receive accurate and comprehensive information about prescription medications.  Compounding these concerns is the fact that four of the top officials in OPDP, including the director and deputy director, have left the agency, and regulatory counsel and policy staff involved in OPDP research were laid off as part of the RIF orders.

In addition to his letter to FDA, Senator Durbin has introduced bipartisan legislation aimed at addressing deceptive advertising practices by the pharmaceutical industry.  The “Protecting Patients from Deceptive Drug Ads Online Act,” co-sponsored with Senator Mike Braun (R-IN), seeks to close regulatory gaps by empowering FDA to issue Warning Letters and impose fines on social media influencers and telehealth companies that promote prescription drugs without proper disclosures of risks and side effects.  The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians.

It’s unclear whether there are truly regulatory gaps that require new legislation.  While FDA has historically looked at manufacturer promotion, the language in the Federal Food, Drug, and Cosmetic Act (“FDCA”) provides that it is a “prohibited act” to cause the misbranding of a drug in interstate commerce.  False and misleading prescription drug advertisements misbrand drugs, and the provision in the FDCA need not be limited to those ads published by manufacturers but could apply to anyone facilitating the sale of prescription drugs.  With regard to influencers, the Federal Trade Commission (“FTC”) maintains its Endorsement Guides and, in 2021, sent over 700 Notice of Penalty Offenses letters, a number of which were directed toward pharmaceutical companies.  While FDA may have primary responsibility over prescription drug advertising, FTC also has broad authority over advertising, generally.

Getting back to manufacturer-sponsored DTC promotion, this was clearly a focus of OPDP enforcement in 2024:  four out of the five Untitled Letters issued dealt with DTC promotion and three of these letters specifically targeted advertising that utilized a celebrity.  This year is shaping up a bit differently – with all four OPDP enforcement letters addressing healthcare professional materials (including a speaker slide deck!!).  These bloggers have questions about this noticeable shift and whether it is a sign of new priorities at the agency or a result of OPDP simply clearing its desk of in-process enforcement letters post-RIF.  Some of those questions may be answered soon:  Durbin’s letter concludes by posing several questions to Commissioner Makary concerning the current state and planned future of OPDP and requests responses by June 17, 2025.  HPM will continue to monitor and report on any response from FDA, as well as the evolving landscape of prescription drug advertising.

NB:  As attorneys that work closely with pharmaceutical companies on their product communications, we may (admittedly) be biased, but demonizing pharmaceutical companies and DTC Rx drug ads oversimplifies issues and fails to acknowledge the important role DTC Rx drug ads may play in improving healthcare.  DTC Rx drug ads keep consumers informed about health conditions and available treatments, destigmatize certain conditions, and ultimately encourage consumers to take a more proactive role in their health.  Prescription drugs require a healthcare professional’s involvement, which should quell concerns that the DTC ad is the only education a consumer is receiving about their condition and treatment.  Further, while the nexus between DTC Rx drug ads and drug spend has been a focus, there has been little research on the overall value that greater consumer involvement in healthcare brings.  Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.  Healthier populations are more productive.  While much has been made about the increase in spending on DTC oncology drug ads, for example, according to NIH research, cancer death rates have been dropping by more than 1.5% annually for the past 15 years and “[e]ach 1% reduction in cancer deaths has a present value of nearly $500 billion to current and future generations of Americans.” (flip the “Health & Economy” piece on the NIH website.)  While we recognize it is a dramatic leap to correlate greater oncology drug (ad) spend with improved cancer outcomes, our point is simply that it is worth considering the overall context of societal costs/gains instead of focusing almost exclusively on pharma ad spend.