This Week at FDA: Pfizer’s tornado fallout, penicillin shortage, and FY2024 user fees

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, Pfizer said it may face drug shortages after a tornado hit one of its facilities, FDA published user fee rates for its various programs for FY2024 and public health officials are worried about an ongoing penicillin shortage.

According to the Washington Post, Pfizer said last week's tornado damage to its Rocky Mount, NC, facility could cause 65 of its products to face “continued or new supply disruptions in the near-term.” The list of products that could be affected includes lidocaine and morphine, but not the company’s coronavirus vaccine.

Public health officials are discussing whether an ongoing shortage of Pfizer’s penicillin drugs Bicillin constitutes a public health emergency amid spiraling syphilis cases. The Department of Health and Human Services (HHS) is reportedly considering convening a federal task force to address the crisis, according Bloomberg and Market Watch.

FDA has published user fee rates for FY2024 for its prescription drug, generic drug, biosimilar and medical device user fee programs, as well as fee rates for outsourcing facilities.

STAT reported that a former director of the National Center for Advancing Translational Sciences (NCATS) has launched the NCATS Alliance, a new lobby group that aims to press Congress for more funding toward translational research. The group is seeking a 16% increase in funding for NCATS in 2024 which would raise its budget to slightly more than $1B.

Drugs & biologics

FDA has published a final guidance on its process for recognizing voluntary consensus standards (VCS) related to pharmaceutical quality aimed at promoting innovation in pharmaceutical development and manufacturing. The guidance details FDA's plans to publish a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality and describes its policies and procedures for recognizing such standards.

FDA has also adopted ICH’s revised guidance on mutagenic impurities, entitled, “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.”

The Foundation for the National Institutes of Health (FNIH), the National Cancer Institute (NCI) and the Oncology Center of Excellence at FDA will hold a virtual meeting on 24 August to discuss plans for creating a public-private partnership (PPP) to help develop new treatments for patients with ultra-rare cancers. The participants are expected to discuss “collaborative open-science, open-drug development process for targeted therapies for ultra-rare cancer indications.”

The US Government Accountability Office (GAO) this week issued a report on the status of FDA’s implementation of the exclusivity provisions of OTC drugs under the CARES Act. The legislation offered 18 months of market exclusivity for these drugs for new uses or if they have innovative ingredients. FDA was given new tools under the legislation to regulate OTC drugs including sunscreens and cold medicine. According to GAO, no company had sought approval for innovations that would qualify for the exclusivity as of May.

We also read this report from STAT on a recently posted Form 483 that FDA handed to Central Admixture Pharmacy Services over microbial contamination found at its Allentown, PA facility. According to STAT, some of the findings were repeat observations from previous inspections, and the issues contributed to numerous recalls within the past year.

FDA issued a warning letter to Stratus Biosystems for manufacturing products for allogenic use, including an umbilical cord and amniotic membrane derived products, without an approved application. The agency said these products do not qualify to be regulated as human cell, tissue, or cellular-based products (HCT/Ps).

FDA sent a notice of noncompliance to Llew Keltner of Light Sciences Oncology in Friday Harbor, WA, for failing to submit clinical trials information to the ClincialTrials.gov data bank. The company has 20 days to submit this information or face civil money penalties.

Fierce Pharma reports that Verrica Pharmaceuticals finally racked up an approval for its Ycanth (cantharidin/VP-102) becoming the first therapeutic approval in the US for molluscum, a viral skin infection, after receiving two rejections from FDA.

Medtech

FDA has submitted a notice of proposed rulemaking to the Office of Management and Budget that, if finalized, would clarify that laboratory developed tests are considered medical devices.

The agency will hold a public meeting of its Cellular, Tissue and Gene Therapies Advisory Committee on 27 September. The panel will discuss a biologics license application (BLA) from BrainStorm Therapeutics for debamestrocel (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors) to treat amyotrophic lateral sclerosis (ALS).

FDA released a guidance on its labeling recommendations for hydrogen peroxide-based contact lens care products submitted in premarket notification 510(k) submissions. The agency said the labeling recommendations “are intended to promote the safe and effective use of HPCPs and help consumers receive and understand information regarding the benefits and risks associated with the use of the device.”

FDA announced it has recognized a new international consensus standard on using low-temperature vaporized hydrogen peroxide to sterilize medical devices. The agency said the standard offers an important alternative sterilization method amid the Environmental Protection Agency’s (EPA) effort to limit the use of the sterilizing agent ethylene oxide (EtO).

Abbott has issued a Class I recall of its Amplatzer Steerable Delivery Sheath due to an increased risk of air bubbles into patients who have procedures with this device. FDA said that air embolism can lead to sudden reduction in blood flow to the heart, fast or slow heartbeat, low blood pressure, and lack of enough oxygen in the blood, and can potentially lead to other serious health consequences including stroke and death.

Abiomed has issued a Class I recall of its All Impella left sided blood pumps for risk of motor damage after contact with Transcatheter Aortic Valve Replacement (TAVR) stent. There is concern use of the devices may cause serious injuries or death.

GE HealthCare is recalling malfunctioning TruSignal sensors that are used to monitor the amount of oxygen found in blood flowing through the arteries and pulse rate through a sensor placed on the skin. The faulty sensors may lead to reduced energy sent to the heart during defibrillation, which could prevent patients receiving lifesaving therapy during a cardiac arrest.

This Week at FDA: Pfizer’s tornado fallout, penicillin shortage, and FY2024 user fees

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