This Week at FDA: Agency allows Florida to import drugs; Biden turns to DPA to address drug shortages

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week FDA authorized Florida to import Canadian drugs, President Biden has directed HHS to use the Defense Production Act to address drug shortages, and congressional Republicans have raised several issues with the agency.

In major news this week, FDA announced it has authorized Florida’s Agency for Health Care Administration’s drug importation program to import drugs from Canada, making it the first state to gain federal authorization to do so. FDA said the move is the first step in the process to bring in cheaper prescription drugs from the country’s northern neighbor.

The announcement was met with strong pushback from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Partnership for Safe Medicines, both of which argued that allowing the importation of unapproved drugs from Canada poses a danger to public health.

While there hasn’t been any reported progress related to FDA’s budget in Congress, lawmakers have been busy raising their concerns with the agency. On Wednesday, Republican leadership on the Energy & Commerce Committee wrote to FDA Commissioner Robert Califf raising concerns about the agency’s internal scientific dispute resolution process.

The same day, Rep. Gregory Murphy (R-NC) wrote to Califf to ask what FDA is doing to prepare for an increase in the number of artificial intelligence/machine learning (AI/ML) premarket submissions, whether it plans to use the Third Party Review program to address the increasing workload and whether Califf supports using voluntary alternative pathways to authorize such products.

President Joe Biden has directed the Department of Health and Human Services to use its power to increase the domestic production of essential drugs, biologics, medical countermeasures and drug ingredients that are facing a shortage under the Defense Production Act (DPA).

AgencyIQ noted that despite FDA’s efforts to publish its medical device Quality Management System Regulation (QMSR) by the end of 2023, it failed to do so. The much-anticipated rule is currently listed as being under review by the White House, and likely won't be published until at least the end of January.
Endpoints News reported that FDA has not scheduled any advisory committee meetings for January, noting that in January 2023 it had scheduled three meetings. The next advisory committee meeting scheduled is for the Anesthesiology and Respiratory Therapy Devices Panel to meet on 2 February to discuss how to better evaluate the performance of pulse oximeters.

Drugs & Biologics

FDA issued an alert to health care professionals that they administer promethazine hydrochloride injections by deep intramuscular administration instead of intravenous administration due to a risk of severe chemical irritation and damage to tissues. If they must administer the allergy and motion sickness drug intravenously, they should review the updated labeling to dilute the drug to reduce the risk.

FDA's Oncology Center of Excellence is hosting a webcast detailing 2023 cancer drug approvals. The agency said it plans to review a wide range of cancers, its approval of new drugs, and potentially new uses for already approved drugs.

FDA issued a report per its agreement under the Prescription Drug User Fee Amendment (PDUFA VII) to assess the use of cloud-based technologies to streamline its work. The report highlights challenges to cloud technology, including cybersecurity concerns, but also details its IT modernization strategy.

Asher Mullard analyzed the number of new drugs approved by FDA in the journal Nature. He noted the agency approved 55 new drugs in 2023 – 50% more than in 2022 – bringing the 10-year rolling average of drug approvals to 46 a year.

In an article published in The Lancet, several top FDA oncology officials wrote that cancer clinical trials used for premarket submissions have become increasingly complex but noted that the National Cancer Institute's (NCI) Pragmatica-Lung Study offers a simpler and more pragmatic design. The authors note that emulating such trials may be easier and more efficient in answering whether a therapy is effective.

Medtech
FDA issued a letter to health care providers and clinical laboratory staff reminding them that there is a serious risk that herpes simplex virus type 2 (HSV-2) tests used to diagnose genital herpes may provide false positive results. The agency recommended they review the Centers for Disease Control and Prevention's (CDC) guidelines on the tests, caution patients about the limitations of the tests and perform confirmatory tests.
FDA plans to host a webinar to discuss its recent final guidance on using computational modeling and simulation in medical device premarket submissions. Besides taking questions on the guidance, the agency will also discuss how sponsors can use the FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation.

FDA’s Center for Devices and Radiological Health (CDRH) announced it has begun issuing electronic export documents for medical devices. The digitization has long been anticipated, and the agency says it will streamline the exportation process by reducing the time it takes manufacturers to receive their documents.

FDA provided an update on its work evaluating exposure to airborne chemicals that may be released from neonatal incubators made by companies including Drager and GE Healthcare. The agency said the Drager incubators do not need to be run for a week before being used as the new incubators have not raised any alarm bells.

Former FDA Commissioner Scott Gottlieb penned an article in JAMA Health Forum offering up lessons for FDA for regulating AI/ML products. The lessons include relying on well-established regulatory pathways, using a risk-based approach and using existing authoritative benchmarks.

FDA cautioned health care providers about using Synovo's Total Hip System, including resurfacing implants. The agency said three of the components of the system, including the Femoral Resurfacing Cup, the Acetabular Fixation Cup and the Acetabular Bearing, have been significantly modified since the original product was cleared by the agency.

This Week at FDA: Agency allows Florida to import drugs; Biden turns to DPA to address drug shortages

Related topics

Recommended content

Welcome to the new RAPS Digital Experience