At the height of the AIDS pandemic in the 1980s,[1] American citizens begged for a cure.[2] All eyes were on the Food and Drug Administration (FDA). Americans begged for a drug approval that would put an end to this life-threatening disease.[3] Reprieve came in 1987 in the form of AZT, the first drug approved to treat AIDS in the United States. AZT approval relied upon the Anti-Infective Advisory Committee, an expert advisory committee of the FDA, which voted 10 to 1 to approve this drug despite the FDA’s original worries about the drug’s efficacy due to the expedited approval process.[4] Despite some dissent within the research community,[5] AZT approval allowed for change to begin and led to better medications targeting AIDS, demonstrating the importance and validity of advisory committees.[6]
In 1953, President Eisenhower signed legislation that created the Department of Health, Education, and Welfare, (HEW) which later became the Department of Health and Human Services (HHS).[7] Eisenhower created HEW as he believed the “government should provide additional benefits to the American people.”[8] HHS is charged with “enhanc[ing] the health and well-being of all Americans, by providing for effective health and human services by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.”[9] HHS houses the FDA, which plays a uniquely important role in ensuring consumer safety by regulating a variety of consumer products such as food, drugs, biologics, medical devices, cosmetics, etc.[10] The FDA votes to approve or disapprove a product, labeling it as either safe or unsafe for consumer use.[11]
The FDA holds vast regulatory power and its decisions directly impact Americans’ health and safety. The FDA approval process often relies on advisory committees to provide informed and independent expert advice as to whether or not a product should be approved. Advisory committees typically host meetings open to the public, allowing the public to see why certain products have been approved or disapproved and the debates surrounding those conclusions.[12] By utilizing the opinions of the advisory committees, the FDA can cite specific scientific expertise reflecting its decision, thus enhancing its credibility. While advisory committees’ recommendations are non-binding, past decisions have greatly influenced the FDA’s decisions in the approval process.[13]
But in the past few years, the FDA has relied on advisory committees less and less.[14] Most recently, the FDA approved a genealogy test known as AvertD despite a strong 11-2 decision against approval by the test’s advisory committee.[15] AvertD is intended to identify whether or not a patient has a genealogical proclivity for opioid use disorder.[16] AvertD would be used in conjunction with clinical evaluations and patient assessments to determine whether or not a patient may develop addiction to opioids when treating acute pain.[17] AvertD could significantly change the standard of care for practitioners who prescribe opioids and could potentially put many patients at risk if the test is incorrect in its analysis.[18]But members of the advisory committee cited concern due to the clinical validity of the test, bias in sample testing, and lack of safety evaluation of the device.[19] This drastic departure from the advisory committee’s decision could mark a new era for the FDA.
A recent study bythe Journal of the American Medical Association(JAMA) found the FDA typically listens 97% of the time when the advisory committee recommends approval, but disagrees 67% of the time when the committee recommends disapproval.[20] Defection from committee recommendations suggests the FDA may be making its approval decisions based on factors other than scientific data provided by its advisory committees, indicating an FDA pro-approval bias. Committee defection is dangerous as it suggests that the FDA may be considering outside factors other than scientific evidence[21] in the approval process with no clear explanation for those undisclosed considerations. In fact, one economist speculated the FDA is using advisory committees, not as a guide for whether or not something should be approved, but to assess which avenues could be used to ensure the approval of a product.[22] If accurate, the notion that the FDA is looking for avenues to give approval would undermine the FDA’s credibility and raise concerns that improper motivations may be influencing the approval process.
Furthermore, the FDA’s disregard for advisory committees’ opinions leads to a lack of transparency because the public can only attend advisory committee meetings, not the FDA’s decision making meetings.[23] The FDA’s administrative opaqueness in decision making breeds doubt in the FDA itself and its processes; it also undermines the value of advisory committees in cases where the FDA steamrolls over nearly unanimous disapproval recommendations.[24] Members of the public who blindly rely on the FDA’s standards and assume that they are listening to the advice of its advisory committees may be exposed to products that should not be on the market.
The FDA not only listens to its advisory committees less, but advisory committee presence has also greatly decreased. In 2012, 50 committees were convened.[25] Each subsequent year, the number of advisory committees decreased, and by 2021, only 18 committees were convened.[26] It appears that in the wake of the FDA’s current pro-approval phase the FDA made a decision: rather than face public backlash for approving a product that an advisory committee voted against, the FDA reduced advisory committee influence in the decision-making process.[27]
Advisory committees provide invaluable recommendations to the FDA. Advisory committees are created to provide helpful and impartial information to the FDA when they are deciphering whether or not to approve a new product. Without advisory committees, the FDA is left relying on potentially biased information, as the data comes from the drug company’s testing agents,[28] which reflects a lack of commitment to scientific rigor and patient safety and access. Without advisory committees, the public is forced out of the decision-making process, and outside political or market influences[29] can influence what should be a health and safety-centric approval system. The FDA should reincorporate advisory committees into its decision-making process or risk becoming an untrustworthy authority.
[1] History.com Editors, AIDS Crisis Timeline, History.Com (Feb. 18, 2025), https://www.history.com/topics/1980s/hiv-aids-crisis-timeline.
[2] Michail Takach, How AIDS Activists Fought for Patients’ Rights, History.Com (Nov. 30, 2022), https://www.history.com/news/act-up-aids-patient-rights.
[3] Id.
[4] Albert R. Jonsen & Jeff Stryker, The Social Impact of Aids in the United States 91-92 (1993).
[5] Id.
[6] Id.
[7] Digital Communications Division, HHS Historical Insights, U.S. Dep’t of Health and Hum. Serv. (Mar. 14, 2023), https://www.hhs.gov/about/historical-highlights/index.html.
[8] Chester J. Pach, Jr., Dwight D. Eisenhower: Domestic Affairs, UVA Miller Center, (https://millercenter.org/president/eisenhower/domestic-affairs#:~:text=As%20President%2C%20Eisenhower%20thought%20that,of%20Health%2C%20Education%20and%20Welfare.
[9] About HHS, U.S. Dep’t of Health and Hum. Serv. (last visited Feb. 5, 2025), https://www.hhs.gov/about/index.html#:~:text=The%20mission%20of%20the%20U.S.,public%20health%2C%20and%20social%20services.
[10] What does FDA Regulate?, U.S. Food & Drug Admin. (Mar. 29, 2024), https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate.
[11] Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19, U.S. Food & Drug Admin. (Apr. 13, 2023), https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventative-and-therapeutic-drugs-covid-19.
[12] Advisory Committees: Critical to the FDA’s Product Review Process, U.S. Food & Drug Admin. (May 4, 2016), https://www.fda.gov/drugs/information-consumers-and-patients-drugs/advisory-committees-critical-fdas-product-review-process#:~:text=The%20primary%20role%20of%20an,assurance%20of%20a%20responsible%20process.
[13] Veronica Salib, Understanding FDA Advisory Committees, Aims, and Members, TechTarget (Dec. 12, 2022), https://www.techtarget.com/pharmalifesciences/feature/Understanding-FDA-Advisory-Committees-Aims-and-Members.
[14] Genevieve P. Kanter, The Real Question the FDA is Asking Its Advisory Committees, JAMA Health F. (July 7, 2023), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807051.
[15] Judy George, Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say, Medpage Today (Oct. 21, 2022), https://www.medpagetoday.com/painmanagement/opioids/101359.
[16] Id.
[17] Id.
[18] Id.
[19] Id.
[20] Genevieve P. Kanter, The Real Question the FDA is Asking Its Advisory Committees, JAMA Health F. (July 7, 2023), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807051.
[21] Id. (discussing the possibilities of why the FDA has a pro-approval bias ranging from increasing speedy public access to treatments or potential big pharma manipulation and political arm twisting).
[22] Id.
[23] Cheri Banks, FDA Staff and Leadership Disagreements and the Role of the AdComm in the Regulatory Process, Fed’n of Am. Scientists (Sept. 10, 2024), https://fas.org/publication/fda-disagreements-adcomm.
[24] Id.
[25] Joseph Ross Daval, et al., Association of Advisory Committee Votes with US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021, JAMA Health F. (July 7, 2023), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050.
[26] Id.
[27] Id.
[28] Development & Approval Process | Drugs, U.S. Food & Drug Admin. (Aug. 8, 2022), https://www.fda.gov/drugs/development-approval-process-drugs.
[29] Laura Karas, FDA’s Revolving Door: Reckoning and Reform, 34 Stan. L. & Pol’y Rev. 1, 1-2 (2023) (discussing the frequency of FDA employees exiting the government sector to join the private sector and how this creates bias as employees may consciously or unconsciously vote in favor of regulated entities in the hopes of eventually seeking employment from said private entity).