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The U.S. Food and Drug Administration (FDA) is urging more than 2,200 drugmakers, medical device companies and researchers to comply with federal requirements to publicly report clinical trial results, highlighting ongoing concerns about transparency in medical research.
On Monday, the agency said it sent letters tied to more than 3,000 clinical trials that appear to be missing required results on ClinicalTrials.gov, a federal database intended to provide public access to study findings.
The lack of reported data creates “significant gaps in the public record and a publication bias” that overrepresents successful trials and underrepresents failures, the announcement said.
Federal law requires most sponsors to post summary results within one year of a trial’s completion, but an FDA analysis found roughly 30% of applicable studies failed to comply with that law.
FDA Commissioner Marty Makary said the lack of reporting can distort the medical evidence base, particularly when negative or inconclusive findings go unpublished. He said clinical trial sponsors “have an ethical obligation to make results public.”
“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers,” Makary said. “If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”
When data is withheld, doctors and patients may be unaware of a drug’s danger
The agency framed its outreach as an initial step to improve compliance, noting that it “may” send Pre-Notices for Potential Noncompliance and Notices of Noncompliance.
The FDA can impose fines exceeding $10,000 per day for violations, according to The New York Times, although the agency hasn’t suggested it plans to do that.
Some experts criticized the FDA for relying on voluntary action rather than immediately using its enforcement authority, noting that the agency has historically struggled to enforce reporting.
FierceBiotech reported that over the last 13 years, the agency has sent only preliminary notices to sponsors. Since 2021, it has sent out just eight noncompliance letters.
Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, said Monday’s announcement “equates to a ‘Pre-Pre-Notice of Noncompliance.’”
“How safe would our roadways be if, instead of enforcing the law, police issued pre-pre-speeding-ticket warnings?” he asked, arguing that stronger action is long overdue.
“Few who fail to comply with federal law are bad actors,” Jablonowski said. “But 2,200 companies over 3,000 clinical trials is a product of bad regulation. You simply can’t have that many rule-breakers in an ecosystem that takes federal regulation seriously.”
“This is not just some kind of paper-pushing bureaucratic requirement,” Holly Fernandez Lynch, a University of Pennsylvania associate professor of Medical Ethics & Health Policy, told the Times. “It’s actually a critically important scientific and ethical requirement.”
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Incomplete reporting can have wide-ranging consequences. Without access to full data — including negative results — doctors and patients may be misled about a treatment’s effectiveness or dangers, and researchers may waste time and resources pursuing therapies that have already proven unsuccessful.
Jablonowski said that pharmaceutical companies have a fiduciary duty to their shareholders, incentivizing them to promote positive results. “If those negative results are withheld, drugs will appear safe, appear effective, and appear profitable,” helping companies’ bottom lines.
The reporting requirements trace back to a 2007 law passed after safety concerns involving Merck’s painkiller Vioxx, which was withdrawn from the market after being linked to an increased risk of heart attacks. Internal documents revealed that the company had studies showing the risk years before Merck made that information publicly available.
An estimated 88,000 to 139,000 Americans had heart attacks and strokes as a result of taking Vioxx, The BMJ reported.
The 2007 law aimed to prevent selective disclosure of trial outcomes and ensure a more complete scientific record.
The Times reported that federal officials are exploring additional ways to encourage transparency. The National Institutes of Health plans to launch a journal dedicated to publishing negative trial results, an effort aimed at reducing incentives to withhold unfavorable findings.
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