New FDA legislation will reauthorize FDA user fee agreements for biosimilars, medical devices, and prescription and generic drugs; 7 cases of monkeypox have been confirmed in the United Kingdom, but its mode of transmission is still under investigation; according to a budget report, lowering the Medicare eligibility age to 60 would increase federal costs by $155 billion in a 5-year period.
Senators Richard Burr, R-North Carolina, and Patty Murray, D-Washington, of the Senate Health, Education, Labor and Pensions (HELP) Committee released a draft of the FDA Safety and Landmark Advancements (FDASLA) Act yesterday. As reported in a HELP Committee press release, the FDASLA Act would reauthorize the FDA’s user fee agreements for biosimilars, medical devices, and prescription and generic drugs. The legislation would also strengthen the FDA’s role in overseeing dietary supplements and cosmetics, improving diagnostic test regulation—including COVID-19 tests—and increasing competition to reduce drug prices, among other areas. The FDASLA Act will also ensure transparency and accountability from the FDA regarding user fees it collects from industry.
A monkeypox outbreak in the United Kingdom has raised concerns from the CDC, which worries there may be additional undetected transmission of the virus and that it could spread into other nations. STAT News reported 7 confirmed cases and 1 probable case of monkeypox since early May, which is deemed a large number considering monkeypox is generally uncommon and especially rare outside of West and Central Africa. One person with the virus had recently traveled to Nigeria, where monkeypox is endemic. While the rest of the cases appear to have been contracted within the United Kingdom, none of these people had any known connection to the person traveling from Nigeria and it appears that the individual was not the source of the domestic infections. However, among the 6 other cases and the probable case, 3 of them are a family unit and 4 are men who have sex with men, making 2 distinct groups with no connection to each other. Investigation into the outbreak is ongoing.
In a report by the Congressional Budget Office and Joint Committee on Taxation on the effects of lowering the Medicare eligibility age from 65 to 60, the 2 groups found that although millions of more people would be insured, federal budget deficits would increase by $155 billion in the 2026-2031 period. According to the report, these deficits would be a result of federal revenue and mandatory spending policies, including having the federal government pay for health care instead of employers. The $155 billion increase reflects a total $222 billion increase in mandatory spending, slightly offset by a $67 billion increase in revenue.