This Week at FDA: FDA cleared for major reorg, ACLA sues over LDT rule

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 announced that its major reorganization plans have been approved, the agency said it is terminating one of its science advisory boards, and an industry group representing clinical laboratories said it is suing the agency over its plans to regulate laboratory-developed tests (LDTs).

The biggest news this week is that FDA’s reorganization of its Human Foods Program (HFP) and the Office of Regulatory Affairs (ORA), which will be renamed the Office of Inspections and Investigations (OII), has been approved. The changes will go into effect on 1 October, and the agency noted that the ORA restructuring will allow its field operations to better focus on inspections, investigations, and imports.

More than a dozen Democratic lawmakers have written to FDA Commissioner Robert Califf asking him to issue a rule requiring labeling information on hearing aids that states whether they include proprietary software. Specialists and other manufacturers are unable to access these so-called "locked" hearing aids, which could mean expensive repairs, replacements or adjustments for users because only the original manufacturer or network-affiliated clinics or providers have access to the software.

FDA announced that it is terminating its Science Advisory Board to the National Center for Toxicological Research (NCTR) on 2 June. The agency said the board has met very infrequently and the cost of maintaining it is not justified. It also reasoned it is no longer needed because much of its work is already done by the Science Board to FDA.

As expected, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, are suing FDA in the United States District Court for the Eastern District of Texas over the agency's recent final rule to regulate LDTs. The suit argues that FDA does not have Congressional authority to regulate the tests that are regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

The Association for Accessible Medicines (AAM) has submitted comments to Federal Trade Commission (FTC) Chair Lina Khan and Department of Health and Human Services (HHS) Secretary Xavier Becerra in response to a request for information on generic drug shortages from the two agencies earlier this year. In its comments, AAM pins part of the issue on monopsony power, in which large buying groups “exercise anticompetitive buyer-side monopoly power” and pharmacy benefit manager (PBM)/payer consolidation.

We also read this reporting by STAT News on the impact of marijuana rescheduling on scientific research. While the announcement will likely open the door to more robust basic scientific research, it might not be much easier in the near term to conduct clinical research involving cannabis under an investigational new drug application (IND), STAT finds.

Drugs & Biologics

Eli Lilly's cancer drug Retevmo (selpercatinib) has been granted accelerated approval by FDA to treat patients two and older diagnosed with certain medullary or metastatic thyroid cancers. The agency notes it is the first approval for such a treatment for patients under 12 years of age.

The Center for Drug Evaluation and Research (CDER) published a web page listing 10 functions it conducts to ensure drug quality. The agency notes that it is more than just ensuring that the drugs meet certain quality requirements but that the manufacturing facilities where the drugs are made also maintain quality requirements.

Juno Therapeutics' Breyanzi (lisocabtagene maraleucel) has been approved to treat adults with relapsed or refractory mantle cell lymphoma (MCL) who have received two prior therapies, including a Bruton tyrosine kinase inhibitor (BTKi). Before approval, the drug was granted priority review and orphan drug designation and used the agency's Assessment Aid voluntary submission program.

FDA on Friday announced it has selected participants to take part in its Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot program. The pilot was announced last year and aims to speed the development of novel drugs and biologics to treat rare diseases and will feature more “frequent advice and enhanced communication from FDA staff” on clinical study design, choice of control group, patient population, use of nonclinical information, and product characterization.

Reuters reports that FDA reviewers have concerns about Lykos Therapeutics’ new drug application (NDA) for its MDMA drug to treat post-traumatic stress disorder ahead of an advisory committee on Tuesday. In briefing documents posted on Friday, FDA staff noted difficulty interpreting study data and raised questions about the drug’s safety.

FDA announced a two-day public workshop on 11 and 12 July to evaluate the immunosuppressive effects of in utero exposure to drugs and biologics. The workshop is jointly organized by the Office of New Drugs Division of Pediatrics and Maternal Health and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

On Monday, FDA said it approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar product to Alexion’s Soliris (eculizumab) to treat two rare diseases, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). FDA notes that this is the 53^rd biosimilar to be approved in the US, and the 13^th interchangeable biosimilar product.

Medtech

Since creating the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot program under the Medical Device User Fee Amendment (MDUFA V) deal, the Center for Devices and Radiological Health (CDRH) has gradually opened the pilot to various Offices of Health Technology (OHT) and dozens of voluntary sponsors. In its latest update, CDRH announced that as of 30 April, it had enrolled 45 medical devices in the pilot.

In its ongoing efforts to address concerns about shortages that may be caused by the Environmental Protection Agency (EPA) 's restrictions on using ethylene oxide (ETO) to sterilize medical devices, FDA announced it will host another virtual public town hall on sterilization on 12 June.

OptumHealth Care Solutions has initiated a class I recall of its Nimbus II Plus infusion pumps following a similar recall earlier this year by InfuTronix due to several problems, including battery failure, upstream blockage, system errors, and drug product leakage. The problems could lead to infections, delayed therapy, dehydration, seizures, and organ failure.

FDA has finalized a rule that goes into effect 1 July that gives it authority to destroy medical devices valued at $2,500 or less that have been prevented from entering the US market at the border and where the owner or consignee has been given a chance to argue against its destruction. The agency got the authority to implement the rule under the 2021 Safeguarding Therapeutics Act (STA).

Last week, Intuitive Surgical got clearance from FDA to modify the labeling on its da Vinci Xi and X surgical robots to include real-world evidence (RWE) information to support the use of the devices in radical prostatectomy. FDA noted that the RWE data was collected through the National Evaluation System for health Technology (NEST), operated by the Medical Device Innovation Consortium (MDIC).

FDA announced it is participating in three new medical device collaborative communities including the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC), OpenOximetry Collaborative Community, and Smart and Autonomous Medical Systems (SaAMS) Collaborative Community. The communities are public-private forums where industry, FDA and other stakeholders can come together to address issues in the medical device ecosystem.

FDA has updated its list of recognized consensus standards for medical devices, adding more than 70 new or revised standards to the list.

FDA announced it will host a two-day public workshop co-sponsored by the Digital Medicine Society (DiMe) on 26 and 27 June to discuss the use of patient-generated health data in medical device development.

This Week at FDA: FDA cleared for major reorg, ACLA sues over LDT rule

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