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 UK, 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 over 5 years.
U.S. Senate Releases FDA Historic Safety and Progress Bill
Senators Richard Burr, R-North Carolina, and Patty Murray, D-Washington, of the Senate Committee on Health, Education, Labor and Pensions (HELP) yesterday released a safety and security bill FDA Historic Advances (FDASLA). As reported in a HELP committee press release, FDASLA would reauthorize FDA 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 the regulation of diagnostic tests – including COVID-19 tests – and increasing competition to lower the prices of drugs. drugs, among other areas. FDASLA will also ensure transparency and accountability for the FDA regarding the user fees it collects from industry.
UK monkeypox outbreak
An outbreak of monkeypox in the UK has raised concerns from the CDC, which fears there may be further undetected transmission of the virus and it could spread to other countries. New statistics reported 7 confirmed cases and 1 probable case of monkeypox since early May, which is considered a large number given that monkeypox is generally rare and particularly rare outside West and Central Africa. A person infected with the virus had recently traveled to Nigeria, where monkeypox is endemic. While the other cases appear to have been contracted in the UK, none of these people had a known link to the person traveling from Nigeria and it appears the individual was not the source of the domestic infections. However, among the other 6 cases and the probable case, 3 of them are a family unit and 4 are men who have sex with men, making 2 separate groups unrelated to each other. The outbreak investigation is ongoing.
Report shows financial benefits and setbacks of lowering Medicare eligibility age
In a report by the Congressional Budget Office and the Joint Committee on Taxation on the effects of lowering the Medicare eligibility age from 65 to 60, both groups found that even though millions 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 the result of federal revenue and mandatory spending policies, including the federal government paying for health care instead of employers . The $155 billion increase reflects a total increase of $222 billion in mandatory spending, slightly offset by a $67 billion increase in revenue.