This Week at FDA: New guidance, shutdown pay issues, and another inspection overhaul
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 published two guidance documents despite the ongoing government shutdown, some FDA staff reported payroll issues, and the agency is reportedly considering another overhaul of its inspection program.With the government shutdown midway through its fourth week, Federal News Network reported that some of FDA’s staff whose roles are excepted from the shutdown did not receive their paychecks on time this week, or received only a portion of their pay. In a statement to Federal News Network, Health and Human Services Press Secretary Emily Hilliard blamed the issue on a “glitch in the furlough system.”
Amid the shutdown, FDA has begun posting guidance documents before posting a notice of their availability in the Federal Register. This week, FDA published two final guidances, a question-and-answers guidance on expanded access to investigational drugs and a document addressing the selection, development, or modification of fit-for-purpose clinical outcome assessments.
On Wednesday, The Pink Sheet reported that FDA is planning to revamp its inspection program in an effort dubbed the “Simple Reform.” Notably, the move would inspection staff at the Office of Inspections and Investigations into generalists, though some degree of specialization would be retained. The move, if carried out, would undo the agency’s effort to specialize its investigators under its Program Alignment Initiative in 2017.
AgencyIQ reported that FDA updated its website this week to reflect the promotion of three of the agency’s acting leaders to permanently fill their respective roles. Steven Kozlowski has been named the agency’s chief scientist, Elizabeth Miller is now the agency’s associate commissioner, Office of Inspections and Investigations, and Timothy Schell has been named the director of the Center for Veterinary Medicine.
Doug Stearn has announced his retirement from FDA after more than 17 years at the agency. He most recently served as principal deputy associate commissioner for inspections and investigations.
The Senate Health, Education, Labor, and Pensions Committee will hold a hearing next Wednesday focused on delivering cures to patients and maintaining US competitiveness in biotech.
Drugs & biologics
This week, STAT News offered an inside look into how FDA awarded the first batch of nine priority vouchers under its Commissioner's National Priority Vouchers (CNPV) pilot program. STAT noted that while five of the companies that received the vouchers had applied for them, four companies were nominated by FDA staff and “were surprised to learn they were selected.”
On Thursday, ProPublica reported on FDA’s practice of redacting drug names from its inspection reports, writing that doing so “prevented doctors, pharmacists and patients from knowing whether the drugs they counted on were tainted by manufacturing failures — and potentially ineffective or unsafe.”
In a lengthy Form 483 handed to Indian drugmaker Hetero Labs Limited last month, FDA raised six observations concerning the company’s use of an undisclosed warehouse used to store active pharmaceutical ingredients (APIs), intermediates, and key starting materials for FDA-registered facilities that make APIs and finished drugs for the US market. Among the observations, FDA noted the warehouse had no quality unit oversight or procedures for warehousing APIs, intermediates, or raw materials. The investigators also observed multiple pests and animals. “This included birds flying throughout the warehouse buildings, bird droppings on top of [redacted] drums, birds’ nest observed within the top seams of the warehouse, crawling lizards, and cats crawling in between pallets and rows of API and Intermediate drums.”
This week, FDA approved Syndax Pharmaceuticals’ Revuforj (revumenib) to treat relapsed or refractory acute myeloid leuemia with a susceptible NPM1 mutation, GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) to treat relapsed or refractory multiple myeloma, and Bayer’s Lynkuet (elinzanetant) to treat moderate to severe hot flashes due to menopause.
Medtech
MedtechDive reports that health tech firm Ōura plans to seek FDA clearance for a blood pressure feature on its smart ring devices.
