FDA Enforcement Actions

For the first time since the Food and Drug Administration Authorization Act of 2007 was enacted, FDA fined a company for failing to submit required information to ClinicalTrials.gov. The website, which is a “database of privately and publicly funded clinical studies conducted around the world”, was strengthened by the 2007 law. A provision required a certain amount of information to be submitted to the site and provided financial penalties for noncompliance.

On the same date as the fine, April 27, FDA began a three-day meeting on confirmatory trials for oncology drugs. The meeting covered three different drugs, all were reviewed under the accelerated approval pathway. The companies were required to do additional studies, called Phase 4 trials, to confirm efficacy of the drug.

Leaving aside the details of the drugs, the trend is one that is comforting to many advocates. People we have talked to are generally encouraged that FDA is using its authorities to ensure compliance with regulations that provide transparency and development of necessary data.

Transparency has been on FDA’s agenda for more than a decade. It has largely been successful on some tasks: CDER and CDRH both have a “learn” initiative where the basic regulatory requirements are reviewed. CBER, like the other centers, has a wealth of information available online. Yet, calls for additional transparency efforts, especially in light of the ongoing COVID-19 public health emergency, may be needed.

Public confidence in our health system, including the FDA, tanked during the COVID-19 epidemic. The recent wide-spread concern of interference in the FDA approval process for COVID-19 products demonstrates the need for FDA to be as transparent as possible with the American public. We look forward to continued enforcement actions related to already agreed upon requirements.