This Week at FDA: SCOTUS strikes down Chevron deference, CDRH partners with Gates Foundation

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, the Supreme Court issued a ruling that could have consequences for FDA and other federal agencies, FDA entered into a partnership with the Gates Foundation to help underserved patients, and the agency approved several new products.

In a 6-3 ruling on Friday, the US Supreme Court (SCOTUS) overturned the decades-old precedent of Chevron deference in the combined case Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo. The doctrine gave federal agencies significant leeway to interpret law that Congress has not explicitly articulated. As SCOTUSblog noted, the decision sharply curtails the power of federal agencies and will have far-reaching consequences.

The decision could open the door for industry to challenge the oversight authority of agencies such as FDA on a wide range of matters, such as laboratory-developed test (LDT) oversight, or at least slow their ability to enforce regulations. Rep. Frank Pallone (D-NJ), ranking member on the House Energy and Commerce (E&C) Committee, argued the decision, in effect, meant SCOTUS gave itself the authority to regulate issues without the expertise of federal agencies.

“This decision is a naked power grab by a radical, right-wing Supreme Court that has proven dismissive of precedent and divorced from reality," said Pallone. "Let’s be clear: this ruling is the result of years of coordinated, calculated efforts by Republicans and corporations to ensure the Court serves their own special interests – not the law, and certainly not the interests of the American people."

"The Court has just thrust Americans deeper into uncertainty and put a bullseye on more of our bedrock rights and protections, including the very ones that protect our health and safety," he added.

In other news, Kathleen Davies was appointed senior advisor to Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), where she will help shape program strategy, work on agency priority projects, and lead its efforts to modernize its advisory committees. Over the past three years, she has served as senior public health advisor and regulatory policy expert in the Office of Executive Programs.

Cavazzoni and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), penned a blog post how FDA is using its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to help bring new drugs and biologics for rare diseases to market. They noted that so far, CDER has selected three sponsors, and CBER has four sponsors to participate in the pilot.

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), outlined the agency's efforts to modernize its New Drugs Regulatory Program (NDRP) in a Q&A blog post. Over the next year, he noted that the agency plans to improve its user dashboards, and in particular, its Information Request (IR) focused dashboard.

FDA published a draft guidance that details what sponsors should consider when evaluating the drug delivery performance information in the premarket application of their device or combination product, which includes a device component. The agency details what manufacturers should consider when evaluating device design outputs when determining the drug delivery performance of their product.

As mandated by the 2022 Food and Drug Omnibus Reform Act (FDORA), the Government Accountability Office (GAO) investigated how FDA's Office of the Executive Secretariat (OES) handles public communication intended for the commissioner. The report found that the office's procedures and practices aligned with its duties and expectations.

Drugs & Biologics

Due to risks of cytokine release syndrome (CRS) and neurological toxicities, FDA announced a list of products it has approved that are only allowed on the market if the manufacturer adheres to a Risk Evaluation and Mitigation Strategies (REMS) Program. Currently, the program applies to six BCMA- or CD19-directed autologous CAR T-cell immunotherapies.

FDA inspectors handed Indian drugmakers Cipla and Torrent Pharmaceutical form 483s for several issues. Inspectors found issues with Cipla's manufacturing processes, including failing to properly establish and document test methods, insufficient protocols to monitor environmental conditions, and lack of processes to ensure clean environments. They also found that Torrent Pharmaceutical did not have a testing program to assess the stability characteristics of their drugs, failed to review discrepancies in their manufacturing, and lacked procedures to ensure equipment were properly cleaned.

Earlier this week, FDA approved Argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The combination biologic was already approved to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.

Genmab's drug for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, Epkinly (epcoritamab-bysp) received accelerated approval this week. It was reviewed under the agency's voluntary Assessment Aid program and had previously been given priority review and breakthrough designations.

Medtech

The Center for Devices and Radiological Health (CDRH) announced another virtual meeting in its series of town halls to discuss medical device sterilization that is intended to help the Medtech industry find alternative sterilizers to ethylene oxide (ETO) or at least minimize use of the toxic gas that has been associated with cancer. Stakeholders can participate in the July 10 meeting to review a mock pre-submission application when implementing changes to sterilization methods.

CDRH announced that it has entered a partnership with the Bill and Melinda Gates Foundation to create new analytical methods that can be used to develop breath-based diagnostic devices catered to the needs of underserved populations. The diagnostic devices are intended to identify chemicals and biomarkers that can be used to detect diseases and are specifically meant to be less complex and cheaper, so they are more available to people in rural and remote areas.

CDRH also published a page highlighting the careers of several of its officials, including Sean Boyd, director of the Office of Regulatory Programs (ORP) in the Office of Product Evaluation and Quality (OPEQ), and Jessica Wilkerson, senior cyber policy advisor within the Office of Strategic Partnerships and Technology Innovation (OST). The page seems to be a way for CDRH to promote its work and encourage people to come to work for it.

Two companies reported issuing update recalls for their ventilators this week.

Philips Respironics updated a class I recall for its BiPAP V30, BiPAP A30, and BiPAP A40 ventilators with new instructions for using the products according to FDA. The company initially started a recall in March due to a problem with an alarm on the devices that could interrupt or stop therapy altogether. The update states that patients who can tolerate an interruption in therapy should be given an alternative device, and those who can't tolerate the interruption, should be given alternative ventilation and contact the device suppliers to get an alternative device.

Similarly, ZOLL Medical issued an updated recall for its MRI Compatible 731 ZOLL Ventilators, which were recalled because the operator's guide did not include key instructional information about how far the devices must be from a magnetic imaging resonance (MRI) device. The company has updated its labeling to tell users to throw away the old guides, request new guides, and alert users about the proper use of the product.

This Week at FDA: SCOTUS strikes down Chevron deference, CDRH partners with Gates Foundation

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