HHS Officially Closes Non-Disclosure Loophole

By James S. Green Jr., Esq. and Seitz, Van Ogtrop & Green, P.A.

The Federal Court in Seife determined that in issuing a “Final Rule” HSS misinterpreted, and thus misapplied, certain clinical trial reporting requirements found in FDAAA. The Final Rule’s incorrect interpretation, and HSS’s misapplication, of FDAAA’s requirements created what the Federal Court in Seife held to be an unlawful loophole, by exempting certain clinical trial reporting requirements for ACTs studying unapproved, unlicensed, or uncleared products that reached their primary completion date on or after the effective date of the Final Rule, Jan. 18, 2017—even if the Federal Drug Administration (FDA) later approved, licensed, or cleared the product.

Accordingly, in the wake of the Seife decision, HSS, acting through the National Institutes of Health (NIH), closed the loophole and now requires, and has threatened to enforce, the submission of registration and results information by sponsors and other “responsible parties” to ClinicalTrials.gov for ACTs:
i. that were initiated after September 2007 or that was ongoing as of Dec. 26, 2007;
ii. that reached the primary completion date before January 2017; and
iii. that studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.

Indeed, in the wake of the ruling in Seife, the FDA and NIH credibly have stated the intention to take action against responsible parties for a failure to submit all required, not simply this newly required, results information. Specifically, in late July, NIH issued a formal Policy Change, made updates to the ClinicalTrials.gov FAQ page that officially accepted and adopted the Seife ruling, and most recently, issued a letter notice warning clinical trial sponsors to submit the additional data to ClinicalTrials.gov “as soon as possible” at the risk of potential penalties.

Each of these actions signals the FDA’s and NIH’s commitment to comply with the expressed purpose of FDAAA and “increase the availability of information to the public” and “communicate the risks and benefits of drugs” in order to “help patients, providers, and researchers learn new information and make more informed healthcare decisions.” (H. Rep. 110-225 (2007) at 12.)