This Week at FDA: MDUFA V deal takes shape; E&C to review FDA bills next week

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. The biggest news of the week is that FDA and industry have reached a tentative deal on the next iteration of the Medical Device User Fee Amendments (MDUFA V). Also, this week Congress passed its long-delayed FY2022 omnibus spending package, the FDA has issued a number of class I recalls, and lawmakers are gearing up to discuss a number of key FDA-related bills next week.

The FDA confirmed to Regulatory Focus they have reached a framework with industry for a new device user fee deal two months after they were supposed to send a MDUFA V commitment letter to Congress. The agency says it is holding daily meetings with industry representatives to hash out the final deal before making it public.

Medical Devices

The FDA issued a number of class I recalls this week, including one for Medtronic’s TurboHawk Plus directional atherectomy system due to risk of tip damage. It’s only the latest recall of a catheter in recent months related to tips breaking off or being damaged that could harm patients.

The agency also issued a class I recall for certain Baxter SIGMA Spectrum and Spectrum IQ software-controlled infusion pumps due to the risk of not alarming for repeated upstream occlusion events.

In an unusual step, the FDA also reprimanded Philips for the second time in a safety notification for not adequately notifying patients and providers about a June 2021 recall of certain Respironics ventilators, positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.

The agency issued a similar reprimand in a November inspection report stating Philips had not taken sufficient steps to address concerns about foam components degrading in its breathing devices that pose a risk for serious harm to patients, including increased risk of cancer.

The agency also issued warning letters this week to device manufacturers CardioQuip, LLC, for its Modular Cooler-Heater Model MCH-1000 devices and to Wickimed Medical Equipment Manufacturing Co., Ltd., for its Sterile Single Use Disposable Electrodes.

Drugs and biologics

Another major development this week is the release of a revised draft guidance that would give drug manufacturers and repackagers more flexibility in responding to requests for verification from trading partners for suspect or illegitimate products. The 2013 Drug Supply Chain Security Act (DSCSA) mandated that trading partners have systems in place to determine that a product is suspect, as well as systems for quarantining and investigating suspect product and systems for processing saleable returns.

House Democrats this week introduced the Accelerated Approval Integrity Act (H.R. 6963) that would also set a 5-year limit for how long a drug can stay on the market without confirmation of clinical benefit or significant progress toward that goal. If made into law, it would codify the FDA’s authority to require that drug sponsors complete postmarketing studies on drugs that receive accelerated approval.

The Office of Management and Budget (OMB) is evaluating a proposed rule from the FDA that would establish requirements for a drug product that could be marketed as a nonprescription drug product. It would add a condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers in order to be sold over-the-counter.

What’s we’re watching

The House Energy and Commerce (E&C) committee is gearing up for a big day next Thursday, 17 March. Lawmakers will take up a slew of pieces of health care legislation including the much awaited 21^st Century Cures 2.0 and President Biden’s Advanced Research Projects Agency-Health (ARPA-H) project to create a new health care research agency modeled after the Defense Advanced Research Projects Agency (DARPA).

What we’re reading

Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services (CMS) has continued to advocate for congressional action to reduce drug prices during a meeting with New York government officials according to STAT News.

The outlet also reported that drugmaker AbbVie has reached a settlement with Alvotech that sought to sell a biosimilar version of the Humira blockbuster drug.

Medtronic has also reportedly entered a partnership with Rockley Photonics, known for working with Apple to develop health-monitoring features for products such as Apple’s Watch according to Fierce Biotech. The move highlights the Minneapolis medtech giant’s recent investments into digital health technologies and machine learning products.

This Week at FDA: MDUFA V deal takes shape; E&C to review FDA bills next week

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