This Week at FDA: Califf’s budget testimony, ISO IDMP guidance, 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 testified before the House Appropriations committee on the agency’s FY 2024 budget request. FDA also issued guidance on implementing ISO IDMP and approved the first over-the-counter naloxone product to treat opioid overdoses.

On Wednesday, Califf testified before the House Appropriations Committee, where he faced criticism from members on both sides of the aisle over the agency’s handling of the infant formula crisis, food safety, inspections and more. Califf’s push for the Biden administration’s $7.2 billion budget request likely did little to move Republicans on the committee, some of whom have called for cutting the budget to the FY 2022 level. Rep. Andy Harris (R-MD), who chairs the subcommittee responsible for FDA’s funding, called the administration’s FY 2024 budget request “unrealistic,” but said he recognizes “there may be an argument for additional resources at the agency.”

On Friday, FDA issued final guidance on the implementation and use of ISO Identification of Medicinal Products (IDMP) standards, which have been in development for more than a decade. The standards are intended to improve the accuracy, completeness and consistency of information about medicinal products among international stakeholders. Use of the standards could lead to improved drug safety and pharmacovigilance, medicinal product traceability and facilitate regulatory registration in other jurisdictions through use of common terminology.

This week, FDA announced its generic drug program will resume in-person, face-to-face meetings with industry as of 27 March. The agency said that such meetings will initially only be available for pre-ANDA product development meetings and pre-submission meetings at the applicant’s request. Availability may be limited by facility capacity and logistical considerations, FDA said.

The agency also announced the approval of the first OTC naloxone nasal spray to treat opioid overdoses, following a recommendation from its Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees last month. While the move is intended to improve the availability of the standard opioid overdose treatment, critics have cautioned that making available without a prescription could lead to affordability issues.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” said Califf.

Earlier this week, FDA announced the launch of a new public-private partnership with the Lupus Research Alliance, the Lupus Accelerating Breakthroughs Consortium (Lupus ABC). FDA said the consortium will is “focused on addressing challenges impacting lupus clinical trial success,” and will bring together patients, medical societies, industry, academia, clinical researchers and federal agencies.

In other news, the Government Accountability Office (GAO) released a report this week calling on the National Institutes of Health (NIH) to increase its oversight of research involving animals conducted by foreign facilities. The report found that the agency paid $2.2 billion in contracts or grants over the decade spanning FY 2011-2021 to foreign organizations for research involving animals, and while those organizations are required to comply with US requirements for animal welfare as well as annual reporting requirements set by NIH, the NIH “does not verify the reliability of annually reported information” by conducting site visits or third-party verification to determine whether such reports are reliable.

Politico reports that House Energy and Commerce Health Subcommittee leaders wrote to Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER) pressing him on the agency’s use of holds on clinical trials for cell and gene therapies following reporting by the Wall Street Journal. “CBER should not, for example, use clinical holds as a means for FDA to gain additional time to review a clinical protocol,” Subcommittee Chair Brett Guthrie (R-KY) and Ranking Member Anna Eshoo (D-CA) wrote.

Drugs & biologics

FDA released the latest figures for its generic drugs monthly activities report, adding data for February 2023. The agency said it approved 46 abbreviated new drug applications (ANDAs), five of which were first-time generics, and tentatively approved another 21 applications, bringing the agency’s FY 2023 total to 272 approved ANDAs and 74 tentatively approved ANDAs.

The agency also released a Form 483 it handed to Global Pharma Healthcare following an inspection of its facility in Tamil Nadu, India in February and March 2023. The report lists 11 observations citing issues with the company’s sterilization validation, test methods, equipment, aseptic processing areas, laboratory controls and quality unit oversight.

NBC News reports that FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics and Reproductive and Urologic Drugs Advisory Committee are slated to meet on 9 May to review HRA Pharma’s Rx-to-OTC switch request for its daily birth control pill Opill (norgestrel).

Medtech

Earlier this week, FDA issued final guidance providing recommendations on general considerations for animal studies intended to evaluate medical devices. The guidance finalizes a draft version released in 2015. The agency said that revisions were made in response to comments received and that the guidance was revised to have “increased emphasis of the 3Rs to reduce, refine, and replace animal use in testing when feasible, reorganization of the guidance to better represent the study design, conduct, and reporting process, clarification of important terminology, and technical edits.”

FDA also announced that its voluntary eSTAR program is open to combination products submitted via the 510(k) or de novo pathways to the Center for Devices and Radiological Health (CDRH) and CBER.

FDA on Thursday announced it has added a new medical device development tool (MDDT) to its arsenal of voluntary tools meant to facilitate device development. The new tool is the first to be qualified in 2023 and is known as the Computational Tool Comprising Visible Human Project Based Anatomical Female CAD Model and Ansys HFSS/Mechanical FEM Software for Temperature Rise Prediction near an Orthopedic Femoral Nail Implant during a 1.5 T MRI Scan.

The agency also issued a safety communication advising patients and health care providers of safety concerns related to certain dental devices known as fixed, or non-removable, palatal expanders. The devices are used on adult patients to remodel their jaws or treat other conditions and include Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA), Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA), Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA), as well as other similar types of devices. FDA said that such devices have not been cleared or approved by the agency, and that it is evaluating safety concerns, including “serious complications which may require intervention” such as chronic pain, tooth dislocation, tooth loss and bone erosion.

FDA has classified Getinge’s recall of its Datascope Cardiosave Hybrid and Rescue intra-aortic balloon pumps as a Class I recall due to the risk of unexpected shutdown as a result of communication loss between the processor printed circuit board assembly (PCBA) and video generator PCBA. The agency said than an unexpected shutdown could cause unstable blood flow, organ damage or death, though none of the 42 complaints reported by Datascope/Getinge include any injuries or deaths related to the issue.

This Week at FDA: Califf’s budget testimony, ISO IDMP guidance, and more

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