The FDA signs a more intense stance on mandatory testing data releases

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The U.S. Food and Drug Administration (FDA) indicated that it could soon enforce the federal requirement that sponsors of certain trials provide data to the public through the ClinicalTrials.gov database.

The agency on April 27 warned Acceleron Pharma claims it could end up being penalized with $ 10,000 a day if it didn’t meet a 30-day deadline to submit information from a 2017 study to the ClinicalTrials.Gov website. It is the first threat of compliance by the FDA, which has so far sought voluntary compliance.

The agency issued one statement on April 28, from FDA Acting Commissioner Janet Woodcock, MD, on enhanced enforcement. Woodcock also drew attention to the issue on social media.

“The FDA takes its role in enforcing http://ClinicalTrials.gov results reporting and reporting requirements extremely seriously,” he said in a tweet through his manager @DrWoodcockFDA. “We will continue to encourage voluntary compliance with these requirements and take appropriate action when necessary.”

Advocates promoting greater transparency of the study’s results welcomed the FDA’s action. But they also said they will be watching to see what the agency does beyond its announcement in its application letter to Acceleron.

“This seemed designed to get headlines that say,‘ We’re doing something, ’and if in fact this is the beginning of an application program, it will be fantastic,” said Deborah A. Zarin, MD, said the director from ClinicalTrials.gov from 2005 to 2018 Medscape Medical News in an interview. (Zarin has also been consulted by ClinicalTrials.gov).

But the FDA’s choice of a target for a first possible enforcement action baffled Zarin and others who follow the federal enforcement issue of data disclosure requirements.

The FDA selected a study of a drug that never hit the market and for which the results of the trials have already been made public.

Acceleron posted negative results from the top line that included the dalantercept drug candidate a 2017 press release, in which the company also said it would stop developing dalantercept. In addition, in 2019, the full results of the study will be presented were published in the magazine Cancer. There is a link to Cancer on the ClinicalTrials.gov website, but does not meet the disclosure requirement.

Acceleron had received a softer warning from the FDA in 2020 about its failure to publish data from this trial to ClinicalTrials.gov. Receipt of the most recent letter, which added the possibility of a financial sanction, may have elicited the desired response.

ClinicalTrials.gov, led by the National Institutes of Health, shows that the results of the Acceleron study in question were presented on April 28 and that an initial review of the quality control of these results was completed on May 6. . Acceleron has since presented the results. . As of Wednesday morning, the FDA still needed to complete the quality review, according to the ClinicalTrials.gov website.

In response to Medscape’s investigation into whether Acceleron will face sanctions, the FDA’s press office said in an email: “NIH is conducting a limited review of quality control information on the results of clinical trials that “The FDA will also evaluate the information in the results presented to determine if the non-compliance has been resolved.”

However, the FDA did not provide Medscape with the requested details on why the agency selected the failure of the Accelereron dalantercept trial as the target of the first serious enforcement action.

Missing results are not uncommon

Acceleron’s case is far from the only case of missing study results. In April, the FDA said it had sent more than 40 milder notices, prior notices of noncompliance, on cases related to lack of data.

However, the number of studies listed on ClinicalTrials.gov for which data is missing appears to be much higher. The Evidence-Based Medicine DataLab at Oxford University created a website for tracking these cases using methods the team explained in January 2020. article inside The Lancet.

This website is called the FDAAA Trials Tracker, which is named after the FDA Amendments Act 2007 (FDAAA) which required the publication of studies of products that may fall under the jurisdiction of the agency, such as drugs and medical devices. Starting Monday evening, FDAAA Trials Tracker panel indicated that the disclosure warrant had been completed by only 7348 of 10,101 trials for which disclosures are required.

“It’s unclear why this one was chosen”

Acceleron is not an obvious case for the FDA’s choice of an initial enforcement action, said Zarin, who is now the program director for the Multiregional Clinical Trials Center at Brigham and Women’s Hospital and Harvard University, Boston, Massachusetts.

“If you want to choose one of the thousands of trials for non-compliance, it’s not clear why this one was chosen,” Zarin said. “I would like to see a more systematic and transparent approach to enforcement that would actually alert all trial sponsors that they must comply.”

The FDAAA trial tracker identified cases where the ClinicalTrials.gov site says data is missing for studies related to products that have received FDA approval and are on the market or are being tested.

“Continuation of the application from external organizations”

Proponents of greater transparency in the study’s findings welcomed the FDA’s April 28 announcement of plans for tougher enforcement. But they also said it took a lot of effort to get the agency to control the ClinicalTrials.gov website.

Allied Non-Profit Universities for Essential Medicines (UAEM) in North America said it has long used the Freedom of Information Act (FOIA) to try to force the FDA to provide information about its enforcement of the rules. disclosure. In March, the New York University Law and Technology Policy Clinic filed a FOIA application on behalf of the UAEM.

In a statement, UAEM described the FDA’s April 27 notice to Acceleron as “a hopeful sign that the agency will now take its responsibility to seriously enforce these requirements for test sponsors, and without them continuing to request it.” to external organizations “.

Concerns about the results of the hidden study date back to at least the 1980s, notes Nicholas DeVito, MPH and colleagues in a 2020 article published inside The Lancet. DeVito and his colleagues are in Oxford and work on the FDAAA Trials Tracker.

They noted that it was not until 2017 that the U.S. Department of Health and Human Services enacted the regulations needed to carry out the 2007 mandate that allows the FDA to enforce reports. In his article by The Lancet, DeVito and colleagues write that it was “disappointing” that the disclosure legislation had been “passed and then largely ignored.”

Kerry Dooley Young is a freelance journalist based in Washington, DC. He previously covered health policy and the federal budget for the convening of the Quarterly Congress / QC and the pharmaceutical industry and Bloomberg’s Food and Drug Administration. Follow her on Twitter at @kdooleyyoung.

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