In what may be a shot across the bow for other organizations involved in decontamination of N95 masks for health care facilities, the U.S. FDA inked an Oct. 7 warning letter to the Battelle Memorial Institute, of Columbus, Ohio, over the organization’s lack of adequate medical device reporting (MDR) procedures. The agency had granted Battelle an emergency use authorization for the service in March, which has been updated twice, but said the agency became aware in early August that the site may have been out of compliance with the terms of the EUA. As is often the case with pre-pandemic warning letters, the FDA cited a lack of definition of terms such as “becomes aware” and “caused or contributed,” and for lack of instructions on filing MDRs in a timely fashion. The FDA said in an Oct. 7 press release that Battelle had responded to the Aug. 7 inquiry, but that Battelle’s response failed to resolve the agency’s concerns. The agency threatened to take regulatory action “without further notice” in the absence of prompt correction of the deficiencies.
FDA: Instructions needed for self-sampling from nares
The U.S. FDA has recommended that health care professionals provide patients with written or video instructions that explain the use of self-collection devices for samples from the nares for COVID-19 testing. The instructions can be provided via written or audiovisual media, but should describe the process in a step-by-step manner, which is intended to provide a sample that is sufficient to avoid false negative findings. The bulletin includes links to two sets of instructions that are fit for instruction in a health care setting, including one from the CDC.
House Dems blast FDA decision on lab test review
Three Democrats in the U.S. House of Representatives decried the change in policy at the FDA to allow lab-developed tests (LDTs) to be practiced for the COVID-19 pandemic without undergoing emergency use authorization review. The signers of the letter said the policy was implemented by Secretary of Health and Human Services Alex Azar, and that the change was made over the objections of career scientists at the FDA, although the underlying question is primarily a legal rather than scientific question. The Department of Health and Human Services had rescinded the FDA’s authority to regulate LDTs both during the pandemic and after in August, although the FDA managers had also acknowledged the agency was overwhelmed with requests for EUA review. The letter from Reps. Diana DeGette (D-Colo.), Anna Eshoo (D-Calif.) and Frank Pallone (D-N.J.), characterized the change as the following of a “reckless path,” and would increase the odds of a false negative result. The authors also noted that the change in policy was not undertaken with sufficient notice to allow the FDA to deal with policies and guidances that contain provisions directed toward LDTs for use in the pandemic.
DOJ take-down identifies massive telehealth fraud
The U.S. Attorney’s Office for the Southern District of Georgia said the third in a national series of investigations into telehealth fraud has identified more than $1.5 billion in fraudulent billings to government health care programs for telehealth and other services to beneficiaries of federal health programs. Operation Rubber Stamp has yielded in excess of 30 indictments within the Southern District’s jurisdiction, including “telemedicine executives” along with owners of durable medical equipment companies. Additionally, the Centers for Medicare & Medicaid Services’ Center for Program Integrity has revoked the Medicare billing privileges of more than 250 medical professionals for their participation in telemedicine fraud. The Federal Bureau of Investigation also took part in the investigations.
Health Canada explains COVID-19 disclosures
Health Canada released guidance Oct. 7 explaining its public release of clinical information for COVID-19 drugs and devices imported and sold in Canada under interim orders. While personal and confidential business information will be protected, safety and efficacy information will be made publicly available after Health Canada completes its regulatory review process, according to the guidance. The safety and efficacy information will be automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs and disclosed upon request in applications submitted under the order for importing and selling medical devices. In addition to keeping Health Canada’s decision-making transparent, public access could provide “valuable information that may help with the use or development of COVID19 drugs and medical devices,” the agency said.
GAO says FDA lab safety office lacks teeth
The U.S. Government Accountability Office (GAO) said the FDA’s office charged with a lab safety program, established in 2017, is the subject of internal disagreements regarding the office’s roles and responsibilities. The GAO report said programs administered by the Office of Laboratory Safety (OLS) lack several elements that are critical to oversight of lab safety, such as clear authority to ensure compliance with related safety requirements. The OLS was placed at a lower organizational level than the product centers in a reshuffling of agency offices in 2019, and cannot conduct unannounced inspections of FDA labs, the report stated. OLS further is dependent on the product centers for funding, which GAO said could allow the other center directors to influence the operations of OLS. The FDA responded in an Oct. 8 statement quoting FDA commissioner Stephen Hahn as stating that the agency supports staff safety by means of continued support for a culture ”that prioritizes workplace safety.” Hahn said he initiated a pan-agency work group charged with fostering “a holistic, cohesive and collaborative safety culture” that will examine best safety practices for lab staff. He stated also that the FDA will update the OLS strategic plan with an eye toward ensuring “the success of a strong laboratory safety program.”