In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory vaccination or regular testing along with wearing a face mask at work. Earlier in the month, the FDA extended its pause on non-mission-critical domestic surveillance inspections to February 4, and the Biden Administration announced that it was making at-home test kits available to the American public. Previously, Robert Califf previewed his priorities, if confirmed, to the Senate HELP Committee. Please see details for these and other supply chain developments below:
- On January 13, President Biden convened a meeting of government and private sector stakeholders to discuss ways to improve the security of the software supply chain, particularly for open source software. The discussion centered on security defects and code vulnerabilities, quality assurance measures to detect and resolve defects, and minimizing time of disruption to issue updates. The meeting continued the work of an Executive Order signed by President Biden in May 2021 in response to cybersecurity attacks on government and private industry networks.
- On January 13, the FDA issued metrics on its 510(k) Third Party Review Program, formerly the Accredited Persons Program, which seeks to improve the efficiency of the 510(k) process through the use of accredited third-party review organizations. The metrics of certain third-party review organizations were released as part of the FDA’s Medical Device User Fee Amendments (MDUFA IV) commitments. The 510(k) Third Party Review Program is a voluntary program by which manufacturers of eligible low-to-moderate risk devices may have their submissions reviewed by an organization authorized by the FDA to conduct a primary review. The program allows the FDA to focus its resources on submissions for higher risk devices while maintaining its oversight of the review of eligible lower risk devices.
- On January 14, the Secretary of the Department of Health and Human Services, Xavier Becerra, renewed the declaration of a public health emergency (PHE) pursuant to his authority under Section 319 of the Public Health Service Act. Under the Act, the Secretary must renew the declaration of a PHE every 90 days if the Secretary determines the PHE still exists after consultation with public health officials. During a declared PHE, the Secretary has, for example, the authority to lead vaccine distribution and tracking and make grants or enter into contracts that support the response to the PHE, and the FDA may issue emergency use authorizations for medical products.
- On January 14, the Administration announced it is purchasing 1 billion at-home test kits for the public. Beginning on January 18, Americans can order kits online or by phone. The government is in the process of awarding contracts to secure test kits from manufacturers. Also, beginning on January 15, private health insurers are required to cover the cost of eight at-home tests per month per covered person.
- On January 18, the FDA extended its pause on non-mission-critical domestic surveillance inspections until February 4, 2022, due to the increase in COVID-19 infections with the omicron variant. The FDA will continue domestic and foreign mission-critical inspections. The agency also indicated that it will “proceed with previously planned foreign surveillance inspections that have received country clearance and are within the [Centers for Disease Control and Prevention] CDC’s Level 1 or Level 2 COVID-19 travel recommendation.” It aims to return to its standard foreign surveillance inspection cadence in April.
- On January 21, the FDA expanded the approved indication of the antiviral COVID-19 medication Veklury (remdesivir) to include outpatient settings. The agency has approved use in non-hospitalized adult and pediatric (12 years of age and older, weighing at least 40 kilograms) patients with mild-to-moderate COVID-19 at high risk for progression to severe COVID-19. In a clinical trial, 0.7% (2/279) of patients treated with Veklury required hospitalization versus 5.3% (15/283) in the placebo group. The treatment course is intravenous administration for three days.
- On January 24, the FDA announced it was revising the authorizations of two monoclonal antibody treatments, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), to limit their use to patients likely to have been infected with or exposed to a variant that is susceptible to these treatments. According to the FDA, “Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.” The NIH COVID-19 Treatment Guidelines Panel, which is composed of independent experts, recommended against the use of these two monoclonal antibody treatments. The FDA noted the availability of other therapies, Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, because they are expected to work against the omicron variant.
- On January 26, the Occupational Safety and Health Administration (OSHA) withdrew its emergency temporary standard (ETS), published in November 2021, that set vaccination policy requirements for large private employers. The ETS, commonly referred to as the vaccine-or-test mandate, applied to employers with at least 100 employees and required them to develop a mandatory COVID-19 vaccination policy, with an exception for employers that adopted a policy requiring employees to either get vaccinated or undergo regular testing and wear a face covering at work. The withdrawal of the ETS comes after the U.S. Supreme Court issued a stay of the rule’s implementation.
- On January 26, Representative Anna Eshoo (D-CA) introduced H.R. 6483, the Improved Transparency of Foreign Drug Manufacturing Act, which clarifies reporting requirements related to establishments in a foreign country. Currently, manufacturers provide certain information on drugs and active pharmaceutical ingredients annually. The bill, if passed, would require that information to be reported quarterly. According to Rep. Eshoo, manufacturers would also have to supply comprehensive information about their foreign manufacturing operations to include registration information from foreign upstream establishments that are part of the U.S. drug supply chain.
- In correspondence with Sen. Roger Marshall (R-KS) and Sen. Mike Braun (R-IN), both members of the Senate Committee on Health, Education, Labor, and Pensions, Dr. Robert Califf, President Biden’s nominee for commissioner of the Food and Drug Administration, addressed concerns highlighted by the Senators. Califf stated that, if confirmed, he would continue the trend “toward more widely using real-world evidence in [the FDA’s] regulatory decision-making processes.” He is also looking to hone and advance the VALID Act, which overhauls regulation of in vitro diagnostics (IVD) and laboratory-developed tests (LDTs). In his December testimony before the committee, Califf outlined his immediate priorities if confirmed. His first focus would be to strengthen the FDA’s infrastructure for emergency preparedness and incorporate lessons learned from the COVID-19 pandemic. Second, his focus would be on consumer and patient safety for products regulated by the FDA. Third, Califf emphasized the importance of the FDA staying current and relying on real-world evidence and science and technology for future guidance.
- The New England Journal of Medicine published a commentary on the COVID 3D TRUST initiative, a collaboration of public and private stakeholders that contribute to repositories and hubs of 3D printing with the goal of filling gaps created by supply chain disruptions for face masks, equipment, and other PPE that are crucial to the public health response. The TRUST also provides protocols for designers to follow to help ensure appropriate product development and safety. The NIH made the repositories available at the NIH 3D Print Exchange.
Please do not hesitate to contact us if you have any questions about these developments.