This Week at FDA: Califf faces appropriations grilling, Woodcock’s next steps, 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, FDA Commissioner Robert Califf presented the agency’s budget request for fiscal year 2025 to a House Appropriations subcommittee and faced questions from legislators on several areas of concern, including unannounced inspections in China and India, drug shortages, and transparency.

The agency’s FY 2025 budget request seeks $7.2 billion total program funding, an overall increase of 7.4%, or $495 million, over FY 2024 funding. The increase includes $157 million in budget authority to enhance food safety and nutrition, advance medical product safety, strengthen the agency’s public health and mission support capacity, and modernize FDA’s infrastructure, buildings, and facilities.

Califf told the subcommittee that the funding increase “will allow the agency to continue to leverage new and emerging technologies, as well as providing for immediate and lasting impacts on our work by incorporating new technology and fostering innovation.”

In other areas, the Commissioner told the panel the request includes an $8.3 million increase “to further build on our centralized enterprise data modernization capabilities, as well as $2 million to implement common business processes in data optimization.”

Rep. Andy Harris (D-MD) told Califf that more work is needed to make the budget process more transparent. He acknowledged that while FDA has taken some steps in this area, “I feel that more work remains.”

Harris also expressed concerns about the record-high number of drug shortages this year. “This year, we’ve unfortunately broken a record. A record for drug shortages, with a record 323 medications in shortage now. Many of these shortages are caused by safety concerns identified in overseas manufacturing facilities in China and India. Rather than FDA shifting its focus to react to the shortages when they occur, I think we need to work together to address the root causes of these shortages.”

In other areas, Califf was asked by Rep. Dan Bishop (D-NC) to address the status of unannounced inspections in India and China. In response, Califf said FDA has conducted “almost 100” unannounced inspections in India and that this number is in “double digits” in China.

Along similar lines, Rep. Ashley Hinson (R-IA) asked Califf the number of overseas inspections conducted by FDA in 2023, noting that such inspections accounted for 6% of the agency’s inspections in 2022.

Califf responded that “we’re on the way back but we’re not there yet, so it’s not enough. But I’d also point out what is moving very rapidly is the digital infrastructure to do things in between the inspections to make a difference.”

Califf also stressed that the agency is using other methods of oversight for drug manufacturers. He said that the “digital infrastructure to do things in between the inspections” is moving rapidly. “If you think about just being in a place once every three years or once every five years, a lot can happen. But we learned a lot during the pandemic about digital technologies to look at processes within firms and, we’re working very hard on a quality management grading system with hopes that a public-private partnership will be formed so that the firms that are doing the best job get preference in terms of contracting by health systems,” he said.

Drugs & Biologics

On Tuesday, FDA’s Oncology Center of Excellence (OCE) detailed Project Asha, a collaboration between India’s health authority and the White House Cancer Moonshot program to increase oncology clinical trial access in India. The program will focus on the area of clinical trials and research training, including training for early career researchers and patient-centered clinical trials.

In other news, Janet Woodcock, former CDER director, told the Pink Sheet of her plans to work on rare disease challenges and will be advising the Haystack Project to help rare disease organizations encourage creativity in drug development programs.

On Thursday, FDA approved Genentech’s Alecensa (alectinib) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

FDA also approved Lumicell’s Lumisight (pegulicianine), an imaging drug to assist in detecting cancerous tissue following a lumpectomy; the drug is administered in the form of an intravenous injection before surgery.

In other areas, FDA will now require boxed warnings advising consumers of T cell malignancies following treatment with BCMA or CD19 CAR T immunotherapies following adverse event reports from clinical trials and postmarket adverse events. The warnings will be required on the following products: Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), and Yescarta (axicabtagene ciloleucel).

On Tuesday, FDA issued a batch of new warning letters: one warning letter was sent to Master Paints & Chemicals Corp. in Puerto Rico, for failing to perform potency and microbiological testing on its hand sanitizers, and for using only a density meter to perform finished product strength testing.

Another warning letter was issued to Natco Pharma Limited in Hyderabad, India for lax cleaning procedures in its sterile drug facility and failure to clean and sanitize equipment and utensils at appropriate intervals.

On Thursday, FDA announced that counterfeit versions of Botox (botulinum toxin) had been found in multiple states and that it is aware of adverse events, including hospitalizations, linked to the counterfeit drugs.

FDA announced a virtual workshop exploring drug development for empiric antibacterial therapy in febrile neutropenic patients on 23 April. The workshop will address the design of clinical trials related to the development of antibacterial drug products for treating febrile neutropenia (FN).

Another virtual workshop will be held on 25 April to introduce the new CDER Quantitative Medicines Center of Excellence; the meeting will address the scope and the goals of the program and solicit feedback from the public on their input on policy.

FDA will also be holding a workshop on 25 April on how it develops product specific guidance (PSG) to facilitate generic drug development.

Medtech

FDA issued a warning letter on Tuesday to Soulaire Corporation in Santa Monica, CA, for marketing its External Counterpulsation (ECP) System Model without marketing approval. The ECP is intended to treat patient with chronic stable angina.

There were a rash of recall announcements this week: FDA announced a Class I recall of Boston Scientific’s Obsidio Conformable Embolic for increased bowel ischemia risk when used for lower GI bleeding. Another Class I recall was announced for Fresenius’s Kabi USA’s Ivenix Infusion Pump LVP software for anomalies that can result in serious patient harm or death. Earlier this week, FDA announced the Class I recall of Abbott/Thoratec’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to biological materials buildup during surgery that can cause an obstruction.

FDA announced that it will be hosting its next medical device sterilization town hall on 29 April and plans to solicit feedback on potential topics for future town halls.

On Wednesday, CDRH announced the release of its 2024 Safety and Innovation Report and the CDRH 2024 Innovations Report. CDRH said the two companion reports detail the center’s “commitment to further advance our core pillars of safety and innovation.”

This Week at FDA: Califf faces appropriations grilling, Woodcock’s next steps, warning letters, and more

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