The U.S. House Appropriations Committee said its budget proposal for the Department of Health and Human Services includes $24.4 billion in emergency spending, and $47 billion for the National Institutes of Health (NIH), an increase of $5.5 billion over the enacted level for the current fiscal year. The allocation for the NIH would include $5 billion to improve capacity at the NIH’s institutions and $240 million for research into a universal flu vaccine. The $8 billion directed toward the Centers for Disease Control and Prevention (CDC) is more than $230 million above the enacted level for fiscal 2020, but CDC would also receive a $9 billion emergency supplemental that would enable the agency to make preparations for public health emergencies. Public health data and surveillance activities at CDC would receive $50 million, while $700 million would be applied toward preparedness cooperative agreements. The Biomedical Advanced Research and Development Authority would receive $3.5 billion for development of advanced manufacturing technologies for vaccines and therapeutics, and another $500 million for next generation vaccine manufacturing facility enhancements. BioWorld will cover the committee’s hearing for the budget proposal in a future edition.
The U.S. FDA said the class I recall of intraaortic balloon pumps by Arrow International Inc., of Cleveland, Ohio, is due to the potential for breakdown of connector wires. Both the Autocat 2 and AC3 Optimus pumps incorporate a motor driver that may “break, char and discolor” the motor connector wires, which may trigger an alert and stop, possibly ceasing function without an alarm. The FDA has received 30 associated complaints, although no deaths or injuries have been reported in association with those complaints. The recall affects more than 2,100 devices distributed in the U.S. between March 15, 2018, and May 1, 2020.
The FDA also said it has granted emergency use authorization to the combination diagnostic by the CDC, which test for both influenza viruses and the SARS-CoV-2 virus. This is the third such EUA granted by the FDA, which urged manufacturers to “work with the FDA on combination tests that may be useful in preserving critical testing resources, given the upcoming convergence of the COVID-19 pandemic and the 2020-2021 flu season.
Aetna Inc., of Hartford, Conn., said in a revision to its policy for atherectomy and thrombectomy devices that the use of FDA-approved drug-eluting balloons (DEBs) is medically necessary for treatment of primary lesions and occlusions of the femoropopliteal arteries. Aetna cited a journal article describing a systematic review of the evidence for DEBs and stents, which identified nine studies that included more than 700 DEB patients and more than 600 stent patients. The authors said these treatments may decrease the risk of clinically driven target lesion revascularization, restenosis and amputation with no impact on mortality. The decision to cover these treatments may seem to fly against the FDA’s review of paclitaxel-coated DEBs and stents, which according to Katsanos, et al, are associated with an elevated risk of mortality. Aetna said also that intravascular shockwave lithotripsy of the superficial femoral artery is not covered.
Australia’s Therapeutic Goods Administration (TGA) said it will reduce the registration charges imposed on active implanted medical devices that are listed as prostheses under a prosthesis list compiled by the Australian Department of Health. The 50% reduction in fees is in force for the agency’s 2020-2021 fiscal year. TGA also said that pre-approval is no longer necessary for direct-to-consumer ads in some media.
Health Canada said it will not accept tests for the SARS-CoV-2 virus that demonstrate sensitivity of less than 90% for immunoglobulin G antibodies or total antibodies in samples collected two weeks or later after the onset of symptoms. Specificity must be at least 95%, the agency said, adding that these figures may be amended as new data emerge.
The U.S. Securities and Exchange Commission (SEC) said Erba Diagnostics Inc., of Miami Lakes, Fla., has not filed any periodic reports with the agency since the company filed a Q10 report for the period ending June 30, 2015. The SEC said Erba had reported a loss of $1.778 million for the prior six months, and that the company will be determined to be in default failing a response within 10 days of the July 1 notification. Eternity Healthcare Inc., of Hong Kong, is also said to be delinquent in securities filings.
The FDA said in a July 6 letter to health care professionals that there is an increased risk of a false positive reading associated with reagents used with the Max system test by Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J. The company is said to have disclosed a rate of false positive results of 3% in one study, and the FDA said it is working with BD to resolve the issue.