Eileen's Blog Post #2

The FDA guidance entitled, Certifications to Accompany Drugs, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 was released in its draft form in 2007 and modified and released on March 5, 2009 (http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm).

Target Audience: Sponsors, Industry, Researchers, Investigators, Food and Drug Administration (FDA) personnel

Laws Referenced: Section 402(j)(5)(B) of the Public Health Service Act (PHS Act), 42 USC §282(j)(5)(B) Title VIII of Food and Drug Administration Amendments Act (FDAAA). The law expands the types of clinical trials and related information that must be submitted to the clinical trial data bank (www.clinicaltrials.gov) managed by the National Institutes of Health (NIH). The law states that sponsors must submit a certification of compliance with section 402(j) of the PHS Act for certain applications to the FDA that fall under Sections 505, 515, 520(m), 510(k), or 351 of the Federal Food, Drug, and Cosmetic Act.

Rationale: Sponsors who submit applications to the FDA for approval need to understand when they should submit an accompanying certification with the application. The FDA drafted this guidance to clarify which application types require the certification and which ones may be exempt from certification. In addition, FDA explained how it enforces this recent amendment to the PHS Act.

Summary: Since the implementation of FDAAA, sponsors marketing a drug product, biological product, or a medical device have had to provide information related to their clinical trials so the public could access such information from the clinical trial data bank. However, this amendment has expanded the scope of clinical trial information that sponsors must provide to the FDA and certify that the information collected is done in accordance with 42 USC §282(j)(5)(B), Section 402(j) of the PHS Act.

Resulting Recommendations: An applicant must submit the certification when submitting the following application types:
• New Drug Application (NDA)
• Biologics License Application (BLA)
• Premarket Approval (PMA)
• Humanitarian Device Exemption (HDE)
• Efficacy Supplement to approved NDA or BLA
• Abbreviated New Drug Application (ANDA)
• PMA Panel Track Supplement
• Investigational New Drug Application (IND)
• 510(k) pertaining to a clinical trial
• New Clinical Protocol Submitted to an IND
• Any resubmission of the aforementioned categories

Applicants demonstrate that they have complied with the requirements of 42 USC §282(j)(5)(B) by submitting the FDA form, 3674 Certification of Compliance, under 42 USC §282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42USC § 282j), (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf).

The FDA uses judgment when considering other types of submissions. For example, if a supplement to an approved application does not refer to a clinical trial, or refers to one already certified in the previously approved application, then certification is not necessary. The same applies to a 510(k) application that does not include information related to a clinical trial. Lastly, an IND that does not include a controlled clinical trial and falls under 21 USC § 360bbb does not require certification.

Impact: Under this amendment, sponsors have a greater burden to demonstrate transparency to the FDA, NIH, and most importantly, the public. FDA will have greater responsibility in enforcing compliance with this amendment and communicating information to NIH. The guidance is clear as to what types of applications/submissions require the certification, which should reduce the likelihood of prohibited acts (eg, forgetting to submit the certification when required, not providing clinical trial information when required) and monetary fines for sponsors.