FDA hits company for deviations from drug, device GMPs

The FDA posted a Nov. 9, 2020, warning letter to Tarmac Products Inc., of Miami Gardens, Fla., for violations of Part 820 and two sections of the regulation for drug products. The violations of the device regulations included a failure to exhaustively qualify equipment used in the manufacture of wound dressing products, as demonstrated by out-of-specification results for total aerobic microbial contact and/or Staphylococcus aureus counts. Other deviations from the Quality System Regulation for devices included a failure to perform antimicrobial effectiveness tests for wound care dressing at time points prescribed in the company’s standard operating procedures. The company was also alleged to have failed to comply with validation requirements, including validation to changes to finished device specifications. Among the violations of Part 11 for pharmaceuticals was a finding that the company’s lab records “appeared altered” in connection with testing for a species of Escherichia. The initial result of the test was not found in the audit trail for the product or in the lab notebook, a deviation the FDA said was a repeat finding from two prior inspections. Other violations relating to Parts 210 and 211 include a failure to follow a written testing program for drug stability, and inadequate calibration of testing equipment. The agency posted the Tarmac warning letter March 30, 2021.

Stryker undertakes correction for AEDs

Australia’s TGA said Stryker Australia LLC has undertaken a product correction in response to a lid magnet that could cause premature battery depletion in Lifepak CR2 automated external defibrillators (AEDs). The lid magnet triggers a start mechanism for the defibrillator, although the unit features a power button that can boot the system in the event of a failed lid magnet. Stryker will replace the lid magnets for affected units free of charge and will update the operating instructions. Two complaints have been reported, although no deaths or injuries have been recorded, the TGA said.

MHRA: Creams, ointments may interfere with CGM function

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) said that the skin of some users of the Dexcom 6 continuous glucose monitor by Dexcom Inc., of San Diego, have reacted to the sensor, and thus may have resorted to the use of skin barriers, in the form of patches and creams, to prevent such reactions. However, MHRA said that the use of such products could affect the function of the glucose sensor, and that the problem may not be unique to the Dexcom unit. Patients are advised to consult with their physician to consider whether they should continue using the Dexcom 6.

NICE says liver perfusion suffers for want of evidence of efficacy

The U.K. National Institute for Health and Care Excellence (NICE) said the evidence in support of whole liver perfusion for acute liver failure includes information on procedure-related complications, but falls short on efficacy. Because the data for efficacy are lacking in terms of both quantity and quality, the agency recommends that this procedure be conducted only in clinical trials. Much of the evidence in support of the procedure is derived from studies that had been conducted “some years ago,” NICE said, adding that recent advances in routine care and in liver transplantation have clouded the question of patient selection. The key evidentiary outcomes for any future study are survival, improvement in neurological outcomes and use of these systems as a bridge to transplant.

NIAID testing vaccine allergy hypothesis

The NIH’s National Institute of Allergy and Infectious Disease (NIAID) is conducting a phase II study in the U.S. to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the mRNA COVID-19 vaccines developed by Moderna Therapeutics Inc. or Pfizer Inc.-Biontech SE. “Most of the rare, severe allergic reactions to these vaccines have occurred in people with a history of allergies. A substantial number of these people had previously experienced a life-threatening allergic reaction,” according to the NIAID. The blinded, randomized study will enroll 3,400 adults – 60% of whom must have either a history of severe allergic reactions or a diagnosis of a mast cell disorder, while 40% will have neither. One-third of the participants in both groups will initially be given a placebo while one-third each will be randomized to the Pfizer and Moderna vaccines. The participants are to be closely monitored by allergy specialists.

EC provides emergency funding for COVID-19 research

The European Commission (EC) is releasing its first emergency funding from Horizon Europe, the EU’s new research and innovation program, for research into coronavirus variants. The €123 million (US$146 million), will be granted for three types of projects, including the further development of promising COVID-19 therapeutic or vaccine candidates. The funding also will be used to support research infrastructures designed to speed up data sharing and deliver fast research support and expertise to confront variants and prepare for future epidemics. The third goal is to establish new or build on existing large-scale, multicenter and regional or multinational cohorts, including outside of Europe, that can rapidly advance the knowledge about SARS-CoV-2 and its emerging variants.

Medtronic splits Ninth Appeals’ review of lower court decision

The U.S. Court of Appeals for the Ninth Circuit ruled that a lawsuit against Medtronic plc, of Dublin, may proceed despite a lower court’s dismissal of the suit in favor of Medtronic in 2019. The relators, including the Dan Abrams Co., and nearly 30 U.S. states, claimed that the company was aware that a cervical vertebral body replacement device posed different questions of safety and efficacy than the predicate device, which the litigants said might have triggered a need for a PMA filing rather than a 510(k) filing. The suit was initially filed in 2015, and alleged violation of the False Claims Act along with allegations of violation of the Anti-Kickback Statute. The Ninth Appeals Court dismissed part of the complaint because of the litigants’ assumption that federal government agencies will not pay for off-label use of devices.

Industry, docs push back on prior authorization

A coalition of medical societies and device makers penned an April 7 letter to acting CMS administrator Elizabeth Richter that an expanding use of prior authorization in the Medicare program will create barriers to access to vital services and devices. The final outpatient rule for calendar year 2020 set up a prior authorization requirement for five services provided in outpatient departments and ambulatory surgical centers, following which the CMS added two orthopedic services to the list of items that require prior authorization. Roughly 50 members of Congress had advised the agency against the action taken in the CY 2020 outpatient final, and the authors of the letter requested that the CMS delay the implementation of prior authorization requirements for the two orthopedic procedures. Among the signers of the letter are the Medical Device Manufacturers Association and the American College of Cardiology.