Health Law Daily FDA’s regulations on Basic Results submissions, publication defy statute
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Wednesday, February 26, 2020

FDA’s regulations on Basic Results submissions, publication defy statute

By Jeffrey H. Brochin, J.D.

Responsible parties are unambiguously required to submit, and HHS is required to publish, Basic Results for applicable clinical trials.

A federal district court in New York has ruled that the FDA’s final rule governing what needs to be reported on the ClinicalTrials.gov website misinterpreted the statute. Failing to require the publication of Basic Results for pre-rule, pre-approval applicable clinical trials (ACTs) resulted in harm that Congress sought to eliminate through lawmaking. Responsible parties (as defined in the statute) knew since the Food and Drug Administration Amendments Act of 2007’s (FDAAA) (P.L. 110-85) enactment the statute required them to submit Basic Results for each ACT of a product that is approved, and it was only when HHS promulgated the final rule (81 FR 64982) nearly ten years later, that HHS definitively told responsible parties that they were not required to submit Basic Results for pre-rule, pre-approval ACTs (Seife v. HHS, February 24, 2020, Buchwald, N.).

FDAMA and FDAAA. Enacted in 1997, the Food and Drug Administration Modernization Act (FDAMA) (P.L. 105-115) required the FDA to create a database of information on clinical trials for drugs for serious or life-threatening diseases and conditions. The information was to be disseminated to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers. Pursuant to those directives, HHS and National Institutes of Health (NIH) created ClinicalTrials.gov, an online clinical trial database made publicly accessible in 2000.

However, in 2004, Congress raised concerns about the safety and effectiveness of several FDA-approved products for which unfavorable clinical trial results had not been publicly disclosed, and noted that under FDAMA, negative results might or might not be released by clinical trial sponsors. Congress questioned whether, as a result, clinical trial sponsors were misleading the public about the safety and efficacy of their drugs and devices by publishing only favorable clinical trial results on ClinicalTrials.gov. To address those concerns, Congress enacted the FDAAA, which sought to increase the availability of information to the public and to communicate the risks and benefits of drugs in order to help patients, providers, and researchers learn new information and make more informed healthcare decisions.

Responsible parties and ACTs. To accomplish the foregoing goals, the FDAAA defined a broad set of ACTs for which responsible parties became responsible for submitting certain clinical trial registration and results information, that HHS was in turn required to include on ClinicalTrials.gov. The statute distinguished between two types of results: Basic Results and Expanded Results, and required HHS to include Basic Results for certain ACTs on ClinicalTrials.gov, including for a drug that was approved or licensed, or a device that was cleared or approved.

HHS final rule, ten years later. It was not until September 21, 2016, almost ten years after Congress enacted the FDAAA and nearly six years after the FDAAA’s September 27, 2010 deadline, that HHS promulgated regulations designed to implement the FDAAA, effective January 18, 2017. However, HHS’ interpretation of the statute’s regulatory phrases as to Basic Results submissions was not whether the product is currently approved, licensed, or cleared, but instead whether the product was approved, licensed, or cleared on the date on which the ACT was completed.

As a result of HHS’ interpretation, the responsible party for an ACT completed after the enactment of the FDAAA on September 27, 2007 but before the final rule’s effective date of January 18, 2017 was not required to submit Basic Results if the ACT studied a product that was approved after the ACT’s completion. An investigative journalist and a doctor who oversaw a medical watchdog group both filed suit against HHS, claiming they suffered injuries in fact due to HHS’ exclusion of certain Basic Results data.

Harm that Congress sought to eliminate. The court found that by being denied access to the Basic Results information at issue, the claimants suffered the type of harm that Congress sought to eliminate by enacting the FDAAA. Congress enacted the FDAAA in order to help patients, providers, and researchers learn new information and make more informed healthcare decisions by increasing the availability of information to the public and "communicating the risks and benefits of drugs."

Requiring ClinicalTrials.gov to include Basic Results for pre-rule, pre-approval ACTs ameliorated that concern and furthered those broader goals. Doing the opposite, by contrast, would exempt the responsible parties for every pre-approval ACT completed soon after September 27, 2007 and January 18, 2017 from disclosing negative results regardless of whether thousands of Americans use the product, which would be utterly contrary to the FDAAA’s aims. Accordingly, the court found that the FDAAA unambiguously required responsible parties to submit, and HHS to include on ClinicalTrials.gov, Basic Results for pre-rule, pre-approval ACTs, and HHS’ interpretation to the contrary was set aside.

The case is No. 1:18-cv-11462-NRB.

Attorneys: David A. Schulz (Ballard Spahr LLP) for Charles Seife and Peter Lurie. Jennifer Ann Jude, U.S. Attorney's Office, for Alex M. Azar, II and U.S. Department of Health and Human Services.

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