The FDA announced recently its new policy for the assessment of civil monetary penalties for failure to appropriately register a human clinical study at the clinicaltrials.gov website, providing sponsors with a 30-day grace period before the imposition of CMPs. Sponsors are advised that the penalties can add up quickly, given that the penalty can come to $10,000 a day for each violation.
The FDA said it will hear complaints from other entities about unregistered clinical trials and incomplete registrations, but many of the violations will be detected during inspections under the Bioresearch Monitoring program. The agency will send those suspected of a violation a pre-notice letter describing the violation and requesting that the offending party correct the problem within 30 days of receipt of the letter, but much of the focus will be on high-risk trials and companies with poor compliance records where clinical trial registration is concerned. Another factor will be whether the agency has reason to believe that the sponsor’s conduct of the study is violative for other reasons.
Should the sponsor fail to react within 30 days, the FDA may begin assessing CMPs, but the rule is not yet in force pending the closing of the comment period and finalization of the draft. The FDA said it is taking comment through Nov. 20.
Gottlieb Responds to Questions Regarding Apple De Novos
FDA commissioner Scott Gottlieb took to the agency’s blog recently to discuss the granting of two de novo applications by tech colossus Apple Inc., an event that seemingly caught medical device makers and others by surprise. Gottlieb seemed intent on answering questions about the speed with which the FDA turned around the de novo applications in question, but he did not address what some see as the more important question, that of the simultaneous announcement of the de novos and Apple’s unveiling of the requisite hardware platform, the Apple Watch 4.
The FDA had granted the two de novo applications for the heart monitoring apps to be used with the latest version of the Apple Watch, but the speed with which the agency had reviewed the de novos – which was achieved in no more than 33 days in either case – was no more conspicuous to many than the simultaneous announcement of the granting of the de novos and Apple’s unveiling of the Watch 4. Gottlieb said in a Sept. 26 statement at the agency’s blog, FDA Voice, that the agency was compelled by a need to “encourage greater innovation in digital health.” In addition, Gottlieb said the agency must respond to the perception that regulations are creating drag on digital health, and thus the FDA “must be as nimble and innovative as the technologies we’re regulating.”
Gottlieb makes several other points in this context, but nowhere does he take up the question of timing. It’s not as though this is an entirely exceptional incident. The FDA does, after all, occasionally make announcements regarding a product to coincide with major medical society meetings, but those announcement are often aimed at a more select audience and typically affect an entire class of products. One exception was the safety advisory regarding the Abbott Absorb device for the coronary arteries in early 2017, which the agency placed on its website prior to the expiration of an embargo on a medical society announcement regarding the device.
Left unanswered by Gottlieb’s response is the question of whether the FDA intends to make a habit of cooperating with device makers regarding the timing product announcements. This is a particularly salient question for the smaller companies in this space, who might see in all this a conspicuous degree of bonhomie between a government agency and a company with a market cap in excess of $1 trillion.