This Week at FDA: Shutdown averted, LDT fight continues

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 continued business as usual after a government shutdown was averted over the weekend, stakeholders gave feedback on its proposed laboratory-developed test (LDT) rule, and the agency said it is unsatisfied with Philips’ ventilator recall.

Since we didn’t publish This Week at FDA last week, we wanted to catch you up on one of the most important pieces of regulatory news so far this year, which came out at the end of last week, namely the fact that the US Food and Drug Administration (FDA) finally published a much-anticipated proposed rule to regulate LDTs.

There is plenty of time for stakeholders to comment on the rule, but it is already getting strong opposition from the American Clinical Laboratories Association (ACLA). The lab lobby group argues that the agency is overstepping its authority and would prefer Congress to pass legislation, such as the Verifying Accurate, Leading-edge IVCT Development (VALID) Act to create a new in-vitro diagnostics framework.

Following the proposed rule’s release, top House leaders, Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO), said the proposed rule recognizes the need to take action on how LDTs are regulated but called on lawmakers to pass the VALID Act to "provide a long overdue modernization of the regulatory framework of diagnostics."

Over the weekend, Congressional leaders passed a continuing resolution (CR) to avert a government shutdown that would have forced FDA to furlough almost one-fifth of its staff.

STAT News reported that when lawmakers passed the CR they also extended several programs in the Pandemic All-Hazards Preparedness Act (PAHPA). The parts of the bill that were extended include authorities to appoint national disaster medical system personnel, temporarily reassign state and local personnel for public health emergencies and operate several advisory committees. The report also notes that a provision to encourage the development of medical countermeasures has expired.

STAT News also reported that several lawmakers on the Senate Finance Committee are aggregating ideas to present a bipartisan bill that would address drug shortages, which has been a major issue for FDA. The report states that Senate Finance Chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID) are in early talks, and if a bill is presented to committee, it likely won't happen until early next year.

Compared to recent weeks, FDA has been relatively calm in terms of publishing new guidances. This week, the agency only published three guidances on electronic submission of 510(k) applications, band-dosing, and drugs for stimulant use disorders.

The Centers for Disease Control and Prevention (CDC) proposed a guideline that healthcare providers offer gay and bisexual men and transgender women who have unprotected sex with other men and transgender women access to the antibiotic doxycycline. The agency says the practice could lower the risk for sexually transmitted infections (STI) such as chlamydia, gonorrhea, or syphilis.

The Reagan-Udall Foundation published a report on how FDA can fight misinformation and misunderstandings about regulated products, which has been a priority for FDA Commissioner Robert Califf. The report concludes that the agency needs to respond to consumer needs sooner and preempt misinformation with "relatable, science-based information" through multiple channels.

Reuters reported that the Supreme Court has declined to hear a patent infringement lawsuit brought by the diagnostics company CareDx against Natera and Eurofins Viracor. CareDx argued that Natera's Prospera test and Viracor's TRAC Kidney test violated the patent on its kidney transplant monitoring blood test AlloSure.

Drugs & Biologics

Eli Lilly announced that FDA has sent them a complete response letter (CRL) declining to approve the company's biologic license application (BLA) for lebrikizumab to treat moderate-to-severe atopic dermatitis (eczema). The company says the agency had concerns about a third-party manufacturing contractor, which it plans to address, and noted that regulators raised no concerns about the clinical data package, safety or product labeling.

Novo Nordisk said FDA has approved its Rivfloza (nedosiran) injections to lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 with relatively preserved kidney function. Primary hyperoxaluria is a rare genetic metabolic disorder that causes the liver to overproduce oxalate, which can lead to kidney stones and kidney failure.

Reuters reported that FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-2 that they could not rely on results from Amgen's Lumakras phase 3 clinical trial. The drug is meant to treat a type of advanced lung cancer and was approved through FDA's accelerated approval pathway in 2021.

Medtech

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), wrote a statement saying that the agency "remains unsatisfied" with how the June 2022 recall of certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) devices and continuous positive airway pressure (CPAP) devices has progressed. He said that regulators are not satisfied with Philips' risk analysis of the recalled products and have asked for additional testing. In the meantime, FDA has updated a webpage with more information and resources for those affected.

Shuren also issued a statement announcing that CDRH is expanding the pilot of its Total Product Lifecycle Advisory Program (TAP) to include neurological devices reviewed by the Office of Neurological and Physical Medicine Devices (OHT5). The pilot is part of the Medical Device User Fee Amendments (MDUFA V) deal that FDA negotiated with the medtech industry, and until now, it was limited to breakthrough cardiac devices in the Office of Cardiovascular Devices (OHT2).

CDRH announced it will hold a virtual public workshop on 2 November 2023 on the use of extended reality (XR) technology with orthopedic surgical devices such as stereotaxic navigation and robotic-assisted surgical systems. The workshop will include presentations on current education and training of the devices and their adverse events reporting.

FDA will convene its Radiological Devices Panel advisory committee to get feedback from external experts on the classification of blood irradiator devices meant to prevent metastasis. The agency notes that the current classifications range from unclassified pre-amendments devices to class III devices. The meeting will be held virtually on 7 November 2023.

This Week at FDA: Shutdown averted, LDT fight continues

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