With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials.
During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels and banning menthol in cigarettes. He also oversaw the approval of a record number of new medicines, generic drugs and medical devices.
Yet his departure leaves many questions unanswered, especially those that impact the medical device industry.
Here are just a few of them.
What will become of the 510(k) program?
In November 2018, in a joint statement with Dr. Jeffrey Shuren, the director of the Center for Devices and Radiological Health, Dr. Gottlieb announced that the FDA would be proposing certain changes to the 510(k) program for approving medical devices.
The current 510(k) program has been in place since the 1976 Medical Device Amendments and allows devices to be considered for approval if they are “substantially equivalent” to previously approved devices. The FDA has made a number of changes to this program in recent years, including:
- Increasing premarket expectations for 510(k) submissions
- Implementing a policy refusing to accept incomplete submissions
- Moving toward eliminating the use of the 510(k) programs for Class III medical devices on the market prior to 1976
- Discontinuing the use of 510(k) clearances for devices that raise safety concerns
- Establishing an alternative pathway for review of “well understood” devices
Gottlieb recently stated that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.”
Under his leadership, the FDA discussed the possibility of “sunsetting” older predicate devices and potentially publishing a list of devices cleared using predicates that are more than 10 years old.
What will happen with wearable devices in clinical research?
The FDA has expressed a desire to improve innovation and efficiency in clinical trials using modern data collection methods, including wearable devices and artificial intelligence.
The development of innovative wearable devices has generated interest as a new means of data collection in medicine and medical device research and development. It permits the remote monitoring of patients in trials, and patients also seem to be more willing to participate in trials if it does not require visits to the clinic or hospital—two factors that increase efficiency and reduce costs.
While the use of wearable devices in clinical trials can bring huge benefits, there are also concerns. In addition to the many legal, operational, ethical and scientific methodology challenges, researchers have to contend with regulatory challenges as well.
The FDA has created Master Clinical Trial Protocols to streamline trial processes, enhance data collection and improve data quality.
It will be interesting to see how these protocols will be further developed under the new FDA commissioner.
What’s the status of drugs and devices to treat opioid addiction?
Opioid addiction is one of the most pressing public health crises facing the country, and addressing the problem requires a novel approach. As commissioner of the FDA, Dr. Gottlieb encouraged the creation of new drugs and medical devices that could treat opioid addiction and prevent the occurrence of new cases. The FDA has issued updated guidelines for clinical trials of the new therapies.
The agency also selected eight projects for further development, including a rapid drug screen, a deep transcranial magnetic stimulation device and a smart pill dispenser.
These projects could offer promising solutions to help prevent and treat opioid addiction, so we’ll be following this closely under the leadership of the new FDA commissioner as well.
What’s next for the FDA?
Health and Human Services Secretary Alex Azar has announced that Dr. Norman Sharpless, the current director of the National Cancer Institute, will take the helm at the FDA as acting commissioner.
Dr. Sharpless has had a distinguished career as an oncologist, administrator and researcher. He was the co-founder of two clinical-stage biotechs and supported Dr. Gottlieb’s efforts related to e-cigarettes and tobacco. While it is premature to speculate about how the FDA will fare with a new leader, the selection of Dr. Sharpless has alleviated some of the concern about whether the FDA will be left in steady hands.
While no one knows for sure what the future holds, IMARC’s team of expert clinical research monitors, auditors and consultants can help your company conduct efficient, compliant trials.
Learn more about how our team works with yours.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
