SUNSET rule suspended
The U.S. Department of Health and Human Services announced that the January 2021 rule for sunsetting HHS agency regulations has been suspended pending judicial review, which is due to a lawsuit filed by several public interest groups against the rule. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule mandates that HHS agencies assess regulations every 10 years to determine reviewability under the Regulator Flexibility Act, which requires agencies to evaluate rules for need and appropriateness of impact. A failure to do so would cause any such rules to expire, although the litigants are said to have argued that the SUNSET rule is illegal.
Alliance calls for speedy nomination of FDA commissioner
The Alliance for a Stronger FDA congratulated Xavier Becerra for his appointment at Secretary of Health and Human Services, but urged Becerra to move quickly to nominate an FDA commissioner. Ron Bartek, the group’s president, said that while the center directors are providing solid leadership, “there is no substitute for having a confirmed commissioner who can stand behind long-term commitments.” Bartek said the Alliance members “appreciate the enormous challenges and momentous decisions facing the administration,” due to the ongoing COVID-19 pandemic.
Pandemic costly to TB effort
The global COVID-19 pandemic has put efforts to defeat tuberculosis (TB) back 12 years, the Stop TB Partnership reported March 18. Nine countries with the most TB cases, representing 60% of the global TB burden, experienced drastic declines in TB diagnosis and treatment last year, with those declines ranging from 16% to 41%. Meanwhile, “data emerging from India and South Africa shows that people coinfected with TB and COVID-19 have three times higher mortality than people infected with TB alone,” the group said. Projections last year showed that a three-month pandemic lockdown, followed by a protracted 10-month restoration, could result in an additional 6.3 million cases of TB worldwide between 2020 and 2025 and an additional 1.4 million deaths. So far, the impact has outpaced the projections. Noting how quickly COVID-19 vaccines were developed, Thokozile Phiri Nkhoma, a Stop TB Partnership board member, pointed out that “although TB has been around since the time of the pharaohs, the only approved vaccine is 100 years old and doesn’t fully work, especially in adults.” In addition, first-line TB treatment is several decades old, and drug resistance is on the rise.
FDA announces May 4 patient data meeting
The FDA reported it will hold a May 4 meeting addressing patient data that is generated throughout the medical device product life cycle. Patient-generated data can be used as part of post-market surveillance, and the meeting will take up recommendations made during a previous advisory committee hearing. The meeting is open to the public and attendees need not register for the online meeting.