It’s time to levy penalties for failing to report clinical trial results image

STAT, January 17, 2018
Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

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From the article:

I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part of my firm’s FDA group, my job was to figure out what our clients needed to do to comply with FDAAA’s requirements for registering and reporting the results of their clinical trials on the government website at ClinicalTrials.gov.

The stakes were high enough to justify my hefty hourly rate — the prospect of an initial penalty up to $10,000 for not complying with the law’s requirements, followed by $10,000 a day if violations were not corrected within a 30-day period following notification of noncompliance. Institutions and investigators with National Institutes of Health funding also faced suspension or termination of grants and the possibility that their failure to comply with the rules would be considered in future grant applications. As it turned out, however, fear of enforcement was unfounded. A decade after FDAAA went into effect, the government has never levied a single monetary penalty or withheld research funding under the law. And let me assure you, that’s not because of perfect compliance.

As STAT recently reported, trial sponsors had disclosed only 72 percent of required results on ClinicalTrials.gov as of September 2017, and 40 percent of those reports were made after the legal deadline. On the plus side, this reflects a positive trend, compared to 58 percent compliance two years earlier, prompted in large part by “naming and shaming,” as well as some attention from Congress and then-Vice President Joe Biden.

Nevertheless, even the upswing still leaves quite a bit of the glass empty: Results from more than 1 in 4 trials have still not been properly reported. The ethical consequences are substantial, and the government should be using its considerable enforcement authority to put an end to it. But it isn’t. [...]

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bioethics biotechnology clinical research fda health care finance health law policy innovation intellectual property pharmaceuticals public health regulation research