House Report Criticizes FDA’s Approval of Alzheimer’s Drug
The Food and Drug Administration (FDA) inappropriately worked with the drug manufacturer Biogen for approval of the Alzheimer’s disease drug Aduhelm, according to a report from Democrats on two House committees. Originally approved in July 2021, Adulhelm came under intense criticism for its uncertain clinical benefits, high list price, and potential for side effects like brain bleeding and swelling. The report found the FDA’s interactions with Biogen were “atypical” – particularly through use of joint briefing documents – and failed to follow the agency’s own documentation protocol. The report’s release precedes a highly anticipated January 6 announcement from the FDA on the approval of Lecanemab, another Alzheimer’s drug that uses a technology similar to Aduhelm that targets amyloid proteins in the brain.
OIG Report Calls for Better Part B Oversight
The Centers for Medicare and Medicaid Services (CMS) needs to conduct “robust oversight” to ensure that the agency makes appropriate payments for Part B-covered drugs, according to a new report from the HHS Office of the Inspector General (OIG). Medicare spends about $40 billion every year on Part B drugs, and CMS uses manufacturer-reported average sales price (ASP) for the drug from quarterly sales to calculate provider payments. However, due to incorrect or missing ASP data from manufacturers, CMS was unable to calculate an ASP-based payment amount for 8% of drug codes at least once between 2016 and 2020. According to the report, CMS does not check the accuracy of the manual processes used to analyze ASP data. The report also found that CMS does not incorporate its ASP data collection into watchdog reports.
SAMHSA: 25% of Adults Had A Behavioral Health Disorder in 2021
Roughly a quarter of US adults had a mental illness or substance use disorder in 2021, according to an annual survey released earlier this week by the Substance Abuse and Mental Health Services Administration (SAMHSA). The survey also found that 16% of the population, or 46 million people, met the criteria for a substance disorder in 2021, and only 6% of the 46 million actually sought treatment. Additionally, the survey found that 22% of the population, or 61 million people, used illicit drugs in 2021, with the most commonly used drug being marijuana. The report echoes growing concerns on the prevalence of substance abuse and mental health issues across the nation.
NIH Launches Pilot Telehealth Program for COVID-19
On Thursday, the National Institutes of Health (NIH) launched the Home Test to Treat program, a new pilot program that will provide free COVID-19 health services like tests, telehealth sessions and at-home treatments in selected communities. Later this month, local and state officials in Berks County, Pennsylvania, will be the first to pilot the program. Other communities around the nation will be selected to participate in this program based on need, socioeconomic factors, and access to health care. The NIH is aiming to offer this service to up to 100,000 Americans over the next year.
Sen. Debbie Stabenow Announces Retirement
Sen. Debbie Stabenow (D-MI) announced Thursday that she will not seek re-election and will leave the Senate at the end of her term on January 3, 2025, making her the first Senate Democrat to announce that she won’t be on the ballot in 2024. Formerly a member of the Michigan state Senate and later a member of the US House of Representatives, Stabenow was first elected to the Senate in 2000. Stabenow is the Senate Agriculture Committee’s top Democrat since 2011 and has been a longtime advocate for mental health care and tireless proponent for increasing domestic manufacturing. Stabenow’s retirement announcement created an opening in a key swing state that is likely to attract strong interest from both parties. According to reports, Reps. Debbie Dingell (D-MI) and Elissa Slotnik (D-MI) are already considering a run.
ICYMI: House Offices Reopened to Visitors
After nearly three years of pandemic and security-related restrictions, visitors on official business will no longer require a staff escort in the House office buildings and tourists will be able to access the gallery overlooking the House floor. The removal of these restrictions was ordered by House Republicans, who now control the House with a slim majority in the 118th Congress. The new Republican House majority also ordered the removal of metal detectors at the House chamber, which were first installed in the wake of the January 6, 2021, insurrection on the US Capitol. For the time being, however, staff escorts are still required for visitors to Senate office buildings.