The FDA gives marketing approval for a test that screens for Duchenne muscular dystrophy in newborns; acetaminophen is facing a possible statewide ban in California; the Supreme Court will not rush its decision on the Affordable Care Act.
The FDA has given marketing approval for the GSP Neonatal Creatine Kinase-MM kit, which tests for Duchenne muscular dystrophy (DMD) in newborns, making it the first such approval for the rare muscle disorder, according to JAMA. Laboratories now have the choice to add this test to their newborn screening panels, as it is not yet required by HHS’ Recommended Uniform Screening Panel for newborn screenings. Results can detect potential muscle injury, but they must be confirmed via muscle biopsy or genetic testing.
Acetaminophen, an integral ingredient in more than 600 prescription and OTC medications, is facing a ban in California, says MSN. Although it is often used to reduce fevers and pain, acetaminophen also is closely connected to phenacetin, which was banned in 1983 because it was shown to cause cancer. Proposition 65 mandates that California has to warn its citizens of cancerous chemicals. Those opposed to reclassifying acetaminophen under this law caution against the weak cancer link, while supporters emphasize product safety. The public comment period closes on January 27.
Democrats were disheartened yesterday when the Supreme Court refused to hand down a final decision on the Affordable Care Act (ACA) before this year’s presidential election, details Politico. The justices claim there is no “emergency,” while Democrats worry about possible harm to those who currently have coverage under the law. Previously, a federal judge in Texas declared the ACA unconstitutional. Republicans, meanwhile, cannot agree on an ACA replacement. Last summer, CMS Administrator Seema Verma’s plan was struck down. The new Supreme Court term begins in October.