FDAAA Clinical Trial Data Bank Certification Goes Into Effect

Title VIII of the recently-enacted FDA Amendments Act (“FDAAA”) requires the responsible party of an applicable clinical trial (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § 402(j) have been met.  Under PHS Act § 402(j)(2)(C), as amended by FDAAA § 801(a)(2), the responsible party of an applicable clinical trial that is initiated after September 27, 2007, or that is ongoing on December 26, 2007, must submit to the National Institutes of Health certain required information for inclusion in the clinical trial data bank (i.e., ClinicalTrials.gov) by December 26, 2007, or 21 days after the first patient is enrolled in the clinical trial, whichever is later, unless the clinical trial is ongoing on September 27, 2007 and is not for a serious or life-threatening disease or condition, in which case the information must be submitted by September 27, 2008. 

An “applicable drug clinical trial” is defined in new PHS Act § 402(j)(1)(A)(iii) to mean “a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug subject to [FDC Act § 505] . . . .”  An “applicable device clinical trial” is defined in new PHS Act § 402(j)(1)(A)(ii) to mean “a prospective clinical study of health outcomes comparing an intervention with a device subject to section 510(k), 515, or 520(m) of the [FDC Act] 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 a pediatric postmarket surveillance as required under [FDC Act § 522].”

Pursuant to PHS Act § 402(j)(5)(B), as amended by FDAAA § 801(a)(2), drug and device sponsors must include a certification with their regulatory submissions that they have complied with new PHS Act § 402(j).  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 data bank is available on the National Library of Medicine’s Protocol Registration System website.