In January, the British Medical Journal (BMJ) published an article claiming that only 163 of the 738 clinical trials subject to mandatory reporting on ClinicalTrials.gov had actually registered results. That’s just 22%, as compared to trials not required to register results, of which 10% had done so anyway. Amended in Section 801 of FDA Amendments Act (FDAAA), PHS Act § 40 requires certain results from a broad range of applicable clinical trials to be submitted to the national registry created under the FDA Modernization Act of 1997 (now maintained on ClinicalTrials.gov). The article also indicated that trials funded solely by industry were over 4 times more likely than those with alternative sources of funding to register results.
On February 14th, the BMJ article provoked 3 US legislators—Reps. Henry Waxman (D-CA), Diana DeGette (D-CO), and Ed Markey (D-MA)—to send letters to the heads of FDA and NIH. The letter sent to FDA, addressed to Commissioner Margaret Hamburg, MD, called for the Agency to answer the following 4 questions (quoted):
1) Do the findings of the [BMJ study] correspond with FDA‘s internal data on compliance with the reporting requirements of Section 801 of the FDAAA? Please summarize FDA‘s internal compliance data.
2) Has FDA issued any warning letters, imposed any fines, or otherwise initiated any enforcement actions related to these reporting requirements?
3) Does FDA have adequate resources and authority to enforce these reporting requirements?
4) Does FDA believe additional statutory changes are necessary to address the issues of underreporting of clinical trial data and non-compliance with the reporting requirements in Section 801 of the FDAAA?
The letter sent to NIH was addressed to Director Francis Collins and called for the Institutes to answer the following 3 questions (quoted):
1) Do the findings of the [study reported in the BMJ] correspond with NIH‘s internal data on compliance with the reporting requirements of Section 801 of the FDAAA? Please summarize NIH‘s internal compliance data.
2) Does NIH have adequate resources and authority to implement these reporting requirements?
3) Does NIH believe additional statutory changes are necessary to address the issues of underreporting of clinical trial data and non-compliance with the reporting requirements in Section 801 of the FDAAA?
It’s not yet clear how FDA and NIH will respond and whether or not the BMJ article and subsequent reaction will yield further legislative results that will affect Pearl IRB clients engaged in clinical trials. To-date, FDA has not taken any actions to enforce the PHS Act § 40 registration requirements (although failure to report can result in fines of up to $10,000 per day).
FDA Law Blog provides more helpful insight here.