EPA posts ethylene oxide rule on OMB agenda
The U.S. Environmental Protection Agency (EPA) intends to act on a rule governing emissions of ethylene oxide (EtO) with a final rule by July 2021, according to an entry in the agency’s fall regulatory agenda filed with the Office of Management and Budget. The issue of EtO as a potential carcinogenic came into view for the FDA given the impact on availability of devices sterilized with EtO, although many of the potential responses were limited by the lack of ready commercial availability of alternatives, as well as the limitations of those other methods of sterilization. The most recently listed meeting between EPA officials took place in November 2019, while several medical device societies have advised the agency to proceed with caution, given the potential impact on supplies of devices that are critical to patient health. The EPA indicated it expects to issue a draft rule in March 2021, leaving the agency with four months to gather and respond to what is certain to be a large volume of feedback.
HHS announces sustained support for testing
The U.S. Department of Health and Human Services (HHS) said it is continuing to support efforts to provide testing for the COVID-19 pandemic by sustaining the provision of certain supplies, such as swabs and viral transport media (VTM), at least through March 2021 “and likely longer.” The new commitment is additive to the more than $31 billion already allocated for testing, although the agency does not offer a dollar value for the additional commitments. In addition to the sustained provision of swabs and VTM, HHS will team up with the U.S. General Services Administration to fashion a streamlined process by which U.S. states and territories can purchase point-of-care diagnostic tests for the SARS-CoV-2 virus at a fixed price, thereby eliminating the need for them to negotiate with manufacturers.
FTC gives nod to Stryker/Wright deal
The U.S. Federal Trade Commission (FTC) said it has approved a final order that clears the way for Stryker Corp., of Kalamazoo, Mich., to complete its acquisition of Wright Medical Group NV, of Amsterdam. The FTC said the $4.7 billion acquisition would require that Stryker divest all its assets for total ankle replacement devices and finger joint implants to Colfax Corp., of Annapolis Junction, Md. The agency said the divestiture would have to include all intellectual property associated with the listed devices, as well existing inventories.