Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA Discretion

Judge Naomi Buchwald of the District Court for the Southern District of New York recently found that the Department of Health & Human Services (“HHS”) misinterpreted a federal law requiring it to collect and post data for certain clinical trials, resulting in a 10-year gap in data that must be made publicly available. This decision will affect many clinical trials conducted between the time of the passage of the FDA Amendments Act (“FDAAA”) in September 2007 and the effective date of HHS’s Final Rule in January 2017 – meaning drug companies, medical device manufacturers and academic institutions will be required to post clinical trial data from clinical trials conducted during this time period.

The plaintiffs in Seife v. HHS are Charles Seife, an investigative journalist, and Peter Lurie, a former FDA associate commissioner who is also president of the public health watchdog Center for Science in the Public Interest.

Background

To provide some regulatory context, the ClinicalTrials.gov platform was developed by HHS and the National Institutes of Health (“NIH”) pursuant to the Food Drug and Modernization Act of 1997 (“FDAMA”), which required these agencies to establish, maintain and operate a data bank of information of clinical trials that could be accessed by members of the public, healthcare providers and researchers. Section 801 of the FDA Amendments Act of 2007 (“FDAAA”) imposed further reporting requirements aimed 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.” Among those other requirements, FDAAA obliged “responsible parties” to submit specified “Basic Results” to NIH for inclusion in ClinicalTrials.gov for certain applicable clinical trials (“ACTs”). See our detailed summary of FDAAA and other requirements relating to the clinical trials database here.

On September 21, 2016, almost 10 years after the enactment of FDAAA and nearly 6 years after the deadline imposed on HHS by FDAAA, HHS promulgated its implementing regulations which we blogged about here. Effective January 18, 2017, the regulations declared that for ACTs of a product that is approved, licensed or cleared by FDA, Basic Results must be submitted within a certain time period.  However, for ACTs of a product that is not approved, licensed or cleared by FDA, Basic Results must be submitted only if the ACT had a primary completion date on or after January 17, 2017. If the ACT was completed after the enactment of FDAAA but before the effective date of the HHS Final Rule, Basic Results were not required to be submitted or posted if the ACT was for a product that was approved after the ACT was completed (“pre-Rule, pre-approval ACTs”).

Issue 1: HHS’s Interpretation of Final Rule Implementing FDAAA

When a court reviews an agency’s interpretation of its own regulation, it must apply Auer deference, which requires courts to defer to an agency’s reasonable interpretation of a genuinely ambiguous regulation. But the Supreme Court has recently cautioned that Auer deference does not apply in all cases, which we blogged about here. One such instance is when an agency interprets a rule that “parrots” the statutory text since the words initially come from Congress.

The Court found that the FDAAA unambiguously requires responsible parties to submit, and defendants to include on ClinicalTrials.gov, Basic Results for pre-Rule, pre-approval ACTs. Judge Buchwald compared the text of FDAAA and HHS’s Final Rule relating to the reporting of Basic Results and found that the Final Rule language is virtually identical to FDAAA.  Because the Final Rule parrots FDAAA, Auer deference does not apply to HHS’s interpretation. FDAAA states that “the Secretary shall include in [ClinicalTrials.gov] for each [ACT] for a drug that is approved… or licensed or a device that is cleared… or approved…, the following elements: [Basic Results]” (42 U.S.C. § 282(j)(3)(C)). Looking to the plain language of the statute, “is” of “is approved…. or licensed” or “is cleared… or approved” means a drug or device that is presently approved, licensed or cleared and therefore obligates HHS to include Basic Results on ClinicalTrials.gov for each ACT that studied a product that is presently approved by FDA, regardless of the marketing status of the product at the time when the ACT was conducted.

Defendants argued that such an interpretation of the FDAAA would violate a canon of statutory construction that statutes should not be construed to apply retroactively. However, Judge Buchwald determined that responsible parties knew since the enactment of FDAAA in 2007 that they were required to submit Basic Results for each ACT of a product that is approved. It was only in the 2016 HHS Final Rule, where HHS told parties they weren’t required to submit Basic Results for pre-Rule, pre-approval ACTs, that this requirement changed. Because the Court found that FDAAA unambiguously requires responsible parties to submit, and the government to include on ClinicalTrials.gov, Basic Results for pre-Rule, pre-approval ACTs, the Court granted plaintiff’s motion for summary judgment to hold unlawful and set aside HHS’s interpretation of the Final Rule as contrary to the FDAAA.

Issue 2: FDA’s and NIH’s Failure to Engage in Enforcement Action

FDAAA also created enforcement mechanisms to ensure that responsible parties comply with their clinical trial reporting obligations. HHS was empowered to issue a notice of noncompliance to a responsible party that fails to submit or submits false or misleading clinical trial information. If a violation is not corrected with 30 days, the responsible party will be subject to a civil monetary penalty up to $10,000 for each day the violation is left uncorrected. HHS delegated this power to FDA. NIH must include in the ClinicalTrial.gov entry a statement that “the responsible party is not in compliance” by failing to submit or submitting false or misleading clinical trial information, the penalties imposed for the violation, and whether the responsible party has corrected the information. NIH must also provide a means for the public to easily search ClinicalTrials.gov for notices of noncompliance. To date, FDA has never issued a noncompliance notice under its authority, and NIH has neither posted a public notice of noncompliance nor created a search function for such notices on ClinicalTrials.gov.

Plaintiffs challenged FDA’s and NIH’s failure to issue a noncompliance notice to responsible parties who have failed to report clinical trial information and NIH’s failure to provide a search function for such notices. Defendants argued that their challenged inaction is not subject to judicial review under the APA because the text of the FDAAA assigns discretion to the agencies to decide whether or not to engage in such enforcement actions. The court determined that FDA’s obligation to issue noncompliance notices only arises after FDA determines that clinical trial information has not been submitted or submitted information is false or misleading.  However, that determination is within FDA’s discretion and, since FDA has never made such a determination, FDA has no obligation to issue noncompliance notices.

The court then determined that the NIH notices are required to include information that exists only after FDA exercises its discretion under the FDA notice provision. Requiring NIH to post noncompliance notices on ClinicalTrials.gov without FDA first issuing their noncompliance notice to the responsible party would be “nonsensical” according to Judge Buchwald. Similarly, NIH’s nondiscretionary obligation to create a search function is predicated on FDA’s discretionary obligation to issue noncompliance notices to responsible parties for failing to submit clinical trials data. NIH is not required to create a search function for FDA noncompliance notices that do not exist. The court therefore granted the plaintiff’s motion for summary judgment

What Now?

While the court’s decision requires the results of clinical trials conducted in unapproved products between September 2007 and January 2017 to be posted on ClinicalTrials.gov, it is unclear whether FDA will require responsible parties to report, how long responsible parties have to report, and for HHS to subsequently post, such data.

*Admitted to Maryland Bar. Work supervised by the Firm pending D.C. Bar Admission.