If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical TrialsSection 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42 U.S.C. § 282(j) and took effect September 27, 2007, requires that sponsors of applicable clinical trials (“ACTs”) register the trials and submit the basic results specified in the statute to the ClinicalTrials.gov data bank.

The HHS interpretation discussed in this alert pertains only to the submission of Basic Results.An “applicable clinical trial” or ACT is defined to include both an applicable device clinical trial and an applicable drug clinical trial. See 42 U.S.C. § 282(j)(1)(a)(i). An “applicable device clinical trial” is further defined as “(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and (II) a pediatric postmarket surveillance as required under section 360l of title 21.”

The two recent pronouncements, however – which come after both administrative litigation to clarify applicable requirements and public watchdog criticism about compliance – could signal increased scrutiny and government enforcement in the near future.HHS Did Not Appeal Court Decision: Responsible Parties Must Submit “Basic Results” For Past Applicable Clinical Trials Of Approved Drug, Biological, and Medical Device ProductsIn February 2020, the U.S. District Court for the Southern District of New York invalidated HHS’ interpretation of 42 U.S.C. § 282(j), a statutory provision that was amended in 2007 to require that sponsors of “applicable clinical trials” (“ACTs”) register those trials and later submit “basic results” for public posting to the ClinicalTrials.gov data bank.

By Anne Marie Murphy – As we have reported previously, Title VIII of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Public Health Service Act (“PHS Act”) by adding new section 402(j), 42 U.S.C. § 282(j), which greatly expands the types of clinical trials that must be registered as well as the information on such trials that must be submitted to the clinical trials data bank, www.ClinicalTrials.gov. One of the provisions requires that a certification of compliance accompany certain human drug, biological, and device applications and submissions to FDA:(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUBMISSIONS. -- At the time of submission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act, or section 351 of this Act, or submission of a report under section 510(k) of such Act, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. PHS Act § 402(j)(5)(B), 42 U.S.C. § 282(j)(5)(B).

Specifically, PHS Act § 402(j)(5)(B) states:At the time of submission of an application under [FDC Act §§ 505, 515, 520(m), or PHS Act § 351], or submission of a report under [FDC Act § 510(k)], such application or submission shall be accompanied by a certification that all applicable requirements of [PHS Act § 402(j)] have been met.Where available, such certification shall include the appropriate National Clinical Trial control numbers.Therefore, as a result of the dates listed in PHS Act § 402(j)(2)(C), those drug and device sponsors that make a submission on or after December 26, 2007 must certify to FDA that the requirements of PHS Act § 402(j) have been met.On December 26, 2007, FDA announced the availability of a new form for the certification (Form FDA 3674). According to the new form, drug and device sponsors must make one of the following certifications:A.I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by [FDAAA], do not apply because the application/submission which this certification accompanies does not reference any clinical trial.B.I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by [FDAAA], do not apply to any clinical trial referenced in the application/submission which this certification accompanies.C.I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by [FDAAA], apply to one or more of the clinical trials referenced in the application/submission which this certification accompanies and that those requirements have been met.FDAAA requires FDA to issue guidance on new PHS Act § 402(j), which should further discuss the types of clinical trials covered by the new certification requirement.Information on registering clinical trials in the ClinicalTrials.

gov certain information about the results of such a clinical trial; this information generally must be submitted no later than one year after the primary completion date of the applicable clinical trial unless an exception applies. See section 402(j)(3)(E) of the Public Health Service Act (PHS Act) (42 U.S.C. § 282(j)(3)(E)). The responsible party can submit a certification of delay, a request for an extension of good cause, or a request for a waiver of the requirements for submission of results information.

9 Seife et al v. HHS et al, 1:18-cv-11462 (S.D.N.Y. 2020). Central to the court’s finding was that the FDA’s Administration Amendments Act of 2007, codified at 42 U.S.C. § 282(j), unambiguously requires responsible parties to submit “basic results” reporting measures to the ClinicalTrials.gov website, notwithstanding that later commentary in a 2016 HHS rulemaking stated that it would not interpret the rule to require sponsors to disclose basic results of applicable clinical trials for drugs or devices that were approved, licensed, or cleared after the trial’s primary completion date.

gov reporting requirements, please contact any member of Ropes & Gray’s practice or your usual Ropes & Gray advisor.Seife et al v. HHS et al, 440 F. Supp. 3rd 254 (S.D.N.Y. 2020).42 U.S.C. § 282(j)(3)(C).back to top

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.

Further, Plaintiffs ask that SDNY compel defendants to issue noncompliance notices and provide them in an easily-searchable database on ClinicalTrials.gov.To the best of our knowledge, this is the first litigation arising from FDAAA 801. It’s an interesting tactic, reminiscent of suits brought under FOIA to require agencies and officials to enforce the law (i.e., the FOIA project, EPIC). Because of the strong statutory language with respect to notice of violations in 42 U.S.C. § 282(j)(5)(E)(i)–(ii), plaintiffs do have a persuasive argument that, in this instance, Congress explicitly intended to curtail agency enforcement discretion, and perhaps it will survive a motion to dismiss. But given the extent of Chevron deference and an agency’s discretion to enforce, there is a good possibility that this case will be dismissed.Nevertheless, the case highlights the lack of transparency in the federal government.