This Week at FDA: Tracking tornado-struck Pfizer plant, lawmakers advance PAHPA, 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, key House and Senate committees advanced different takes on reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), FDA is keeping an eye on a Pfizer manufacturing facility struck by a tornado, and more.

The overarching theme for this week was dealing with drug shortages. The House Energy & Commerce (E&C) Committee advanced its version of the reauthorized Pandemic and All-Hazards Preparedness Act (PAHPA) on Wednesday, despite opposition from Democrats who wanted to include certain amendments that would give the FDA the authority to require manufacturers to report potential drug shortages outside the context of a public health emergency.

On the Senate side, however, the Health, Education, Labor, and Pensions (HELP) Committee passed a PAHPA reauthorization bill Thursday, including product shortage notification requirements to the FDA.

The Senate bill also includes a proposal to create a team within the FDA Center for Biologics Evaluation and Research (CBER) that would support the development and authorization of countermeasures to emerging pathogens, conduct surveillance of such countermeasures, and ensure the safety and availability of the nation’s blood supply.

Separate from the HELP committee actions, Sen. Amy Klobuchar, D-MN, proposed a bill that would require manufacturers of certain critical drugs to notify the FDA of shortages.

A group of bipartisan senators wrote to Secretary Xavier Becerra urging the Department of Health and Human Services (HHS) to strengthen the US domestic supply chain of critical health supplies. The senators proposed policies, including incentives for providers to purchase US-produced products and enforcing existing rules on compatibility of foreign-made products.

The Center for Medicare and Medicaid Services (CMS) is addressing the drug shortage issue by proposing to pay hospitals to keep in inventory a 90-day "buffer stock" of 86 drugs that HHS considers critical.

E&C Republicans wrote to FDA Commissioner Robert Califf this week, raising questions about the "FDA’s insufficient foreign drug inspections conducted in India and China." The lawmakers say they are worried that the US is overly reliant on sourcing from foreign manufacturers with "a demonstrated pattern of repeatedly violating FDA safety regulations.”

Sen. Mike Lee, R-UT, has reintroduced the Red Tape Elimination Act that would eliminate interchangeability designation for biosimilars in the US. If enacted, it would amend the federal code to state that all biosimilars, upon approval, shall be deemed interchangeable; get rid of the current interchangeability designation requirement; and require FDA to conduct a private briefing with relevant committee heads if the agency wants to require a switching study.

Pfizer announced that its Rocky Mount, NC, manufacturing plant had suffered heavy damage from a tornado. The plant is one of the largest injectable-product facilities in the world and produces nearly 30% of all sterile injectables used in US hospitals. FDA Commissioner Robert Califf tweeted that the agency is following the situation closely.

FDA has announced that Rosemary Roberts, director of the Counter-Terrorism and Emergency Coordination Staff (CTECS), is retiring in July. Roberts has headed CTECS since 2004, and Kelly Ngan, CTECS associate director, will serve as acting director after her retirement.

Drugs & Biologics

AstraZeneca's respiratory syncytial virus (RSV) drug Beyfortus (nirsevimab-alip) was approved by FDA for children and toddlers. It is indicated for preventing RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

After a year-long delay, Chinese drugmaker BeiGene says FDA has completed its manufacturing inspection for the cancer drug tislelizumab and that its application is moving forward. BeiGene has partnered with Novartis on the drug. FDA had indefinitely delayed its decision whether to approve tislelizumab for second-line unresectable or metastatic esophageal squamous cell carcinoma (ESCC) last July due to COVID-related travel restrictions, according to the companies.

After ordering a stop to sales of mesh products for transvaginal repair of pelvic organ prolapse in 2019, FDA has been studying the products and published data from two aspects of its safety monitoring program. The agency noted that the most common adverse events reports noted pain, injury, disability, infection, inflammation, and nausea.

Bloomberg this week published an in-depth look at the conditions and regulatory lapses that led to a deadly outbreak of Pseudomonas aeruginosa linked to contaminated eye drops made by Indian firm Global Pharma Healthcare. The article, in part, attributes the outbreak to lax FDA oversight of over-the-counter drugs.

FDA researchers recently published a report on how drugs interact with food and how that affects their efficacy. Their findings show that a food’s pH and the length of time it is mixed with the drug affect the drug's performance.

The Center for Biologics Evaluation and Research (CBER) published the cumulative Regenerative Medicine Advanced Therapy (RMAT) designation requests it has received by fiscal year. For FY 2023, it received 27 total RMAT designation requests. Of those, nine were granted, 15 were denied, and none were withdrawn.

Medtech

FDA published revised final guidance on medical device development tools (MDDT) that the agency says streamlines the proposal phase and consolidates it with the incubator phase; clarifies and consolidates sections on qualification decision framework and process; expands certain definitions; and removes an outdated section on initiating MDDTs.

Medtronic is recalling almost 350,000 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured after July 2017 due to concerns they may deliver a reduced-energy shock, or no shock, potentially leading to serious injury or death. The recall comes a year after the company recalled more than 20,000 ICDs for similar issues and two years after it recalled 240,000 defibrillators over reduced battery life concerns.

FDA is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The agency says the safety and effectiveness of the devices have not been established to diagnose, treat, or cure medical conditions, and using them may cause adverse reactions such as pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness.

This Week at FDA: Tracking tornado-struck Pfizer plant, lawmakers advance PAHPA, and more

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