Universities Allied for Essential Medicines Files Citizen Petition at FDA Demanding Agency Fix Underenforcement of Clinical Trial Reporting Regulations
WASHINGTON, DC, February 27, 2023 – Universities Allied for Essential Medicines (UAEM) North America, with assistance from Columbia Law School’s Science, Health and Information Clinic (SHIC), filed a citizen petition at the Food & Drug Administration (FDA) on February 27th to urge the agency to improve enforcement of clinical trial transparency. Transparency laws require public access to studies on drugs and medical devices, benefitting patients and researchers, but FDA has underenforced the law, keeping potentially life-saving data from the public.
“We filed this petition because we want the FDA to enforce the law more, to do so in a way that makes sense from a public health perspective, and to increase transparency and public accountability regarding the agency's enforcement decisions,” says Navya Dasari, member of the UAEM Coordinating Committee and lead of the Clinical Trial Transparency Campaign.
UAEM’s petition demands more and smarter enforcement of clinical trial reporting requirements imposed by the Food and Drug Administration Amendments Act (FDAAA). FDAAA is the key federal clinical trial transparency law, which requires companies, universities, government labs, and other entities that run clinical trials to register their trials on ClinicalTrials.gov and report trial results to the same database. FDAAA empowers FDA to warn those entities when they fail to submit trial results to ClinicalTrials.gov, with Preliminary Notices of Non-Compliance (Pre-Notices) and Notices of Noncompliance.
See UAEM's filed Citizen Petition here.
UAEM’s petition first requests FDA greatly increase its issuance of Pre-Notices and Notices of Noncompliance. Issuing of Notices of Noncompliance enables the agency to impose civil money penalties on noncompliant parties, when appropriate. As of submitting the petition, the FDA has never used its enforcement power to levy these civil monetary penalties against noncompliant trial sponsors.
“FDAAA was signed into law in 2007,” says SHIC student attorney Kasey Clarke, “and the Final Rule clarifying requirements of sponsors has been in effect since 2017, but FDA only issued its first Notice of Noncompliance in 2021, despite having the statutory authority to do so for over a decade.”
Of an estimated thousands of noncompliant trials, FDA has only issued four official Notices of Non-Compliance and under 100 Preliminary Notices of Non-Compliance, leaving a potential $39 billion in fines unclaimed.
“It not only harms the public good by depriving people valuable information concerning their health, the lack of enforcement could bring in an enormous stream of revenue currently being filled by taxpayer dollars,” says Davis Gonsalves-DeDobbelaere, SHIC student attorney.
UAEM’s petition also requests that FDA issue new guidance to implement a new, improved, and expanded framework for prioritization of enforcement. As the petition explains, FDA’s minimal enforcement activities have been unfocused. FDA has enforced compliance by a handful of relatively low-importance trials, while ignoring noncompliance by trials with high importance to public health, public spending, and medical science. UAEM proposes that FDA prioritize enforcement of compliance by NIH-funded trials and trials of FDA-approved products, to maximize the benefits of increased enforcement activity.
Lastly, UAEM’s calls for FDA to make enforcement actions more transparent, by creating a public dashboard to show when and to whom the agency sends Pre-Notices. Currently, FDA keeps Pre-Notices secret, though UAEM and its legal team previously successfully used the Freedom of Information Act to obtain all Pre-Notices issued by the FDA between 2013 and early 2021.
“Patients take and clinicians prescribe treatments based on available clinical trial evidence, making it critical that these are available in their entirety and in a timely manner to prevent against undue harms including significant financial costs should the treatments not have a clear benefit. Published journal articles about treatments are typically subject to positive publication bias, often excluding those with or downplaying negative findings. That is why it is critical for FDA and NIH to make sure that all clinical trial results are made publicly available to give patients and clinicians a complete picture,” says Dr. Reshma Ramachandran, Board President for Universities Allied for Essential Medicines North America.
Filing the Citizen Petition is the latest move in UAEM’s clinical trial transparency campaign, which advocates for increased reporting of clinical trial data. According to UAEM, underreporting of data “can increase bias in studies (due to reduced data), slows down the rate of innovation of new medicines, and ultimately may lead to patient harm or death.”
Enforcement of clinical trial reporting requirements has received increased attention in recent months. In August 2022, The Department of Health and Human Services Office of Inspector General issued a report that the National Institutes of Health, who is responsible for maintaining ClinicalTrials.gov, did not ensure that results were reported in accordance with federal requirements. In October, four Republican Senators sent a letter to NIH demanding greater accountability for clinical trial reporting requirements and seeking information about the agency’s plans for future enforcement. UAEM applauds the increased attention on NIH’s enforcement of clinical trials transparency, and hopes that its petition brings similar attention to FDA’s role in protecting trial transparency.
Citizen petitions are formal submissions to the FDA by which the public can influence the agency’s policy. The FDA receives about 200 petitions per year, and is required to carefully review and respond to each submission. UAEM’s full petition is available at under docket number FDA-2023-P-0660. at www.regulations.gov, and interested parties can submit comments through regulations.gov, here.
About Universities Allied for Essential Medicines (UAEM)
UAEM is celebrating 20 years of student activism and advocacy in the global and domestic fight for health equity and justice in access to medicines. UAEM is rooted in a global movement of university students in 20 countries and aims to (1) promote access to medicines and medical innovations where barriers exist primarily by changing norms and practices around academic patenting and licensing, supported by our own independent research, (2) ensure that university medical research meets the needs of people worldwide and actively supports the creation of new needs-based approaches to R&D, and (3) empower students to respond to the biomedical access and innovation crisis by advocating for the most promising global biomedical R&D system that works for all. http://www.uaem.org
About Columbia Law’s Science Health and Information Clinic (SHIC)
Columbia Law’s Science, Health, and Information Clinic serves the public interest by fighting for—and winning—more equitable access to scientific, technical, and medical knowledge and to the benefits that flow from that knowledge. SHIC student attorneys, under faculty supervision, provide pro bono legal services to activists and organizers, scientific and medical researchers, patient and consumer groups, nonprofit organizations, and other clients. https://www.law.columbia.edu/academics/experiential/clinics/science-health-and-information-clinic