This Week at FDA: FDA’s end-of-PHE moves, warning letters, and more

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 public health emergency (PHE) that had been in place since the beginning of the COVID-19 pandemic ended, triggering several announcements from FDA.

While the lifting of the PHE does not impact FDA’s emergency use authorizations (EUAs), it does affect multiple pandemic era policies and regulatory requirements that applied during the emergency declaration.

As expected, FDA withdrew numerous pandemic-era guidances. FDA laid out its plan for handling the dozens of guidances it issued in response to COVID-19 in a Federal Register notice issued in March.

The agency also issued a notice announcing that while the COVID-19 public health emergency ended on 11 May, the agency will continue to use its authority to exempt COVID-19 treatments from the tracking requirements under the Drug Supply Chain Security Act (DSCSA). FDA made this announcement to transition out of the pandmeic and to “avoid potential supply chain disruptions” that could impact the COVID-19 response.

And, FDA announced that manufacturers will no longer be required to notify the agency of a permanent discontinuance in the manufacture of a medical device. Such reporting was required during the PHE under the Section 506J of the federal Food, Drug and Cosmetic Act. The agency “no longer expects that manufacturers continue to submit 506J notifications for devices.” FDA also published a frequently asked questions guide to help answer questions on 506J notifications.

On Thursday, the Senate Health, Education, Labor and Pensions committee passed several bills aimed at pharmacy benefit managers, drug pricing and generic drugs, STAT reports. Also on the hill Thursday, FDA Commissioner Robert Califf testified before the House Energy & Commerce Health Subcommittee on preparing and responding to future public health threats. Califf’s testimony focused on how the agency’s authorities could be modernized, including by increasing the agency’s oversight of supply chains, enhancing the agency’s operational readiness and overhauling laboratory test regulations.

Drugs and biologics

FDA announced it will convene the Pediatric Oncology Subcommittee of its Oncologic Drugs Advisory Committee on 16 June 2023 to discuss dosage optimization strategies for pediatric cancer drugs. The agency said it has invited representatives from the European Medicines Agency, pediatric oncology drug investigators and drugmakers to attend.

In other news, FDA posted a warning letter on Thursday to Divergent in Fraser, MI for “unacceptable” levels” of acetaldehyde and acetal in its antiseptic hand wipes. FDA said that acetaldehyde “appears to be genotoxic and potentially carcinogenic when in direct contact with tissues.” FDA also reprimanded the company for failing to conduct identify testing for the active ingredients ethyl alcohol and not verifying the supplier’s certificate of analysis (COA) for component specifications. FDA said that failure to address these violations may cause FDA to withhold issuing export certificates and withhold approval of new applications or supplements.

FDA also found similar problems in its warning letter posted on Thursday to Premier Nutra Pharma in Carlsbad, CA. In it, FDA lambasted the firm for manufacturing nasal sprays contaminated with yeast. Investigators said the firm “failed to establish written, approved procedures to prevent microbial contamination during the manufacturing operations” of its nasal spray OTC drug products. The firm also did not have an environmental monitoring program in place, thus increasing the contamination risk of drug products. The company no longer produces drugs at the facility.

FDA will now require sponsors of amphetamine and methylphenidate products, which are stimulants used to treat attention deficit/hyperactivity disorder (ADHD) disorder, to inform patients, caregivers and health care professionals of risks associated with their medications. The agency issued a question and answer guide to assist manufacturers in updating their labeling.

In other news, FDA on Thursday rejected ImmunityBio’s combination therapy to treat bladder cancer due to deficiencies in the company’s application, reports Reuters. In a filing with the Securities and Exchange Commission, the company expressed doubts about whether it will remain in business.

In other news, FDA approved on Wednesday unanimously approved the first OTC birth control pull after nearly two days of deliberation, STAT reports.

On Friday, FDA also announced the approval of Astellas Pharma’s Veozah (fezolinetant) an oral medication to treat hot flashes caused by menopause. The drug is the first neurokinin 3 (NK3) receptor antagonist approved for this indication.

An FDA panel voted in favor of approving ARS Pharmaceuticals’ epinephrine nasal spray neffy on Thursday for the emergency treatment of type 1 allergic reactions, reports BioSpace. The panel found the drug posed a favorable risk-benefit profile in adults.

On Thursday, FDA approved the first drug to treat agitation symptoms associated with dementia. Otsuka Pharmaceutical received a supplemental approval for Rexulti (brexpiprazole).

The Biden administration has “quietly” assembled a team to tackle US drug shortages, reports Bloomberg, and a group of White House officials has been meeting since the beginning of the year to discuss increasing the availability and quality of medicines. These efforts are gaining steam as common drugs like antibiotics go into shortage.

In other news, CNN reports there is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, citing data from the University of Utah Drug Information Service. In the first three months of the year, more than 300 drugs were in active shortages in the US, including nearly 50 new shortages.

FDA reviewers concluded from briefing documents that Sarepta Therapeutics did not demonstrate its gene therapy for Duchenne muscular dystrophy would benefits patients, and the drug posed key safety concerns, according to STAT, which reports that clinical studies released by the company did not provide “unambiguous evidence” that the therapy would benefit ambulatory patients and could also expose patients to liver damage. FDA’s Cellular, Tissue, and Gene Therapies advisory committee met to discuss the application on Friday.

Medtech

This week, FDA released its latest quarterly performance report under MDUFA V, covering the agency’s activities through 31 March 2023.

FDA also authorized the first serology COVID-19 test through the traditional premarket review process by granting a de novo request to VITROS Immunodiagnostic Products for its Anti-SARS-CoV-2 IgG Reagent Pack and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, both for use with the company’s Anti-SARS-CoV-2 IgG Calibrator.

Samsung announced it received FDA clearance for its Galaxy Watch to alert users to irregular heart rhythms, Medtech Dive reports.

This Week at FDA: FDA’s end-of-PHE moves, warning letters, and more

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