On May 2, 2022, UAEM sent a letter to Ron Klain, White House Chief of Staff. The letter requests assurance that White House officials with financial conflicts of interest recuse themselves from the review of the petition asking the government to march-in and exercise other rights to the life-saving prostate cancer drug Xtandi (enzalutamide) originally developed with funds from the National Institutes of Health (NIH) and Department of Defense (DOD) at the University of California, Los Angeles (UCLA). Read the full text here.  

Due to sustained UAEM student organizing the University of California, Los Angeles (UCLA) has at last published the "Affordable Access Plan (AAP)"! The AAP provision is intended to better address the needs of underserved populations so that going forward medicines developed on the UCLA campus are not priced out of reach in low- and middle-income countries.

Dear UAEM Family & Friends, 

It is with a very heavy heart that we write to share the devastating loss to our community with the sudden passing of our Advisory Board Member, Dr Paul Farmer, a world-renowned infectious disease doctor, founder of Partners in Health, humanitarian, author, father and friend. 

Paul’s legacy is so far-reaching that it would be impossible to summarize his extraordinary impact here and so instead we choose to focus on how deeply he inspired and shaped the work of so many of us at UAEM; many of us learned about his early legacy in Haiti and around the world and, as students, had our own hopes and dreams of perhaps one day following in his footsteps.

November 16, Washington, D.C. - Preliminary findings from an ongoing Freedom of Information Act (FOIA) investigation filed on behalf of Universities Allied for Essential Medicines were published in JAMA on November 12, 2021. Led by UAEM North America board member and postdoctoral fellow at the Yale National Clinician Scholars Program, Dr. Reshma Ramachandran, the JAMA article is entitled “Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements.” It focuses on actions taken by the U.S. Food and Drug Administration (FDA) to enforce a federal law that requires the sharing of valuable scientific data with the public. Within the article, Dr. Ramachandran and her co-authors, Drs. Christopher J. Morten and Joseph S. Ross, provide a first-of-its-kind survey of first-step enforcement actions taken by FDA—so-called “Pre-Notices of Noncompliance,” obtained from the FDA through UAEM’s FOIA request—and outline what the agency could do to improve enforcement efforts.

The article, and UAEM’s ongoing FOIA investigation, concern public access to data on clinical trials. FDA shares enforcement responsibility with the National Institutes of Health (NIH) to ensure that drug companies, medical device manufacturers, universities, government laboratories, and other entities that conduct clinical trials comply with legal data-sharing requirements imposed by the FDA Amendments Act (FDAAA) of 2007. FDAAA requires that these entities register clinical trials; report trial results when trials are complete; and share trial protocols and other methodological information with the public—all through an NIH-run website, ClinicalTrials.gov, that makes this information freely available to all. 

However, noncompliance with FDAAA is widespread: While registration of clinical trials through NIH’s ClinicalTrials.gov database has improved significantly since passage of FDAAA and its implementing regulations (the “FDAAA Final Rule,” 42 C.F.R. Part 11), timely reporting by trial sponsors of results information continues to be inadequate. For example, a recent study estimated that 3,000 trials completed between January 18, 2017 and January 18, 2021 remain unreported. 

Despite ongoing and widespread noncompliance with FDAAA, FDA has taken only a few dozen first-step enforcement actions against the drug companies, government labs, and other entities responsible for noncompliant clinical trials. “As of early April 2021, the FDA had only sent a total of 58 Pre-Notices of Noncompliance, with 57 of these for trials that have yet to submit their results to ClinicalTrials.gov. This is just a fraction of the thousands of trials that have failed to meet legally-mandated reporting requirements,” says Dr. Ramachandran. “While the FDA has indicated a willingness to do more by sending three of these Pre-Notice recipients a further Notice of Noncompliance with threat of monetary penalties or criminal prosecution when they still did not submit their results, it is clear that the agency could do so much more to close this compliance gap.”

In examining the recipients who received the Pre-Notices, the study authors found that over 90% of recipients submitted the missing results information (as of August 17, 2021). This finding suggests that Pre-Notices are in fact, effective in improving compliance. 

The study authors also found that no Pre-Notices were sent to federal agencies, including the NIH. This is striking, as NIH itself is responsible for a large number of trials noncompliant with FDAAA. 

“Our study suggests that Pre-Notices work to improve compliance with FDAAA—but only when FDA sends them,” said Dr. Morten. “FDA should do more to target the universities, companies, and government labs chronically noncompliant with FDAAA. NIH should do its part by coordinating with FDA—and sharing the results of its own trials.”

UAEM’s FOIA investigation is in long-running partnership with law school student clinics. On March 10, 2021, New York University School of Law’s Technology Law and Policy Clinic filed initial FOIA requests with the FDA and NIH on behalf of UAEM. “These and subsequent FOIA requests seek to understand whether and when the agencies have engaged in meaningful enforcement of FDAAA,” said Celine Rohr, an NYU Law student who worked on UAEM’s FOIA requests. UAEM’s FOIA-based investigation of FDA and NIH is ongoing, with legal support from Columbia Law School’s Science, Health, and Information Clinic led by Dr. Morten and Southern Methodist University Dedman School of Law’s First Amendment Law Clinic, led by Thomas Leatherbury and Michael Shapiro.

UAEM’s FOIA investigation builds upon its reports published in 2019 (with TranspariMED) and 2021, which reviewed compliance with FDAAA of the top 40 American universities by number of clinical trials. The most recent report released in May 2021 found that while the number of universities in full compliance with FDAAA’s reporting rules had increased (from 13 in 2019 to 17 in 2021), a majority were still noncompliant. 

“Students at the First Amendment Clinic at SMU Law have been excited to support UAEM’s efforts to better promote more understanding of this important federal transparency initiative,” said Shapiro. “That work is set to continue as the Clinic provides legal assistance with UAEM’s ongoing efforts through FOIA to provide access to records that would give a fuller view of how NIH and FDA push groups that conduct clinical trials to show the public their work.”

As part of its commitment to transparency, UAEM and its law clinic partners are making its complete data set of Pre-Notices available to all. The 58 Pre-Notices UAEM obtained from the FDA can be found here.

On October 28th UAEM students and staff supported the organizing for a protest led by allies “People’s Action” in Washington DC demanding world leaders at G20 1) lift vaccine patents and share the technology to allow ALL countries to develop their own vaccines and 2) equitably redistribute surplus vaccines in high income nations. The rally was covered on the front page of Democracy Now. The image that was selected was of our Free the Vaccine banner with “Sharing is Caring” held up by students in Care Bear costumes. Full  coverage of the protest can be viewed here. 

UAEM members Neda Ashtari, along with former UAEM board member Gloria Tavera are the focus of the new documentary, "White Coat Rebels by a documentary team from Participant Media". The documentary examines the pharmaceutical industry from the perspective of advocacy and those who are fighting against its power and influence. In case you missed it at the Silver Spring film festival, it is now closed, but we will announce broader distribution in the coming months. Stay Tuned!