Biden Signs FDA Modernization Act, DOJ Investigates Abbott Facility
President Biden passed the FDA Modernization Act 2.0 that will modify the drug trial process, and Abbott Laboratories faces an investigation at its Michigan baby formula production plant.
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By - This week’s policy roundup reviews the FDA Modernization Act signed at the end of last year, which allows for innovative pathways for pharmaceutical companies to test their drugs. And a new probe of an Abbott Laboratories’ Michigan facility is being pursued by the Department of Justice (DOJ) in response to last year’s baby formula shortage.
Missouri Launches Prescription Drug Monitoring Program
Missouri will expand its St. Louis County prescription drug monitoring program (PDMP), becoming the latest and final state to introduce a state-wide PDMP. Missouri chose Bamboo Health to run the system, requiring pharmacists to record prescriptions in a database accessible to providers. In St. Louis County, the same Bamboo Health system successfully reduced opioid prescriptions from 80.4 per 100 people to 58.3 per 100. READ MORE.
Biden Signs FDA Modernization Act
President Joe Biden signed the FDA Modernization Act 2.0 into law at the end of last year, changing how companies test products before bringing them to market. The act allows companies to test products in several different ways beyond traditional animal-based trials.
“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge. The inclusion of this bipartisan effort is a step toward ending the needless suffering and death of animal test subjects — which I’m glad both Republicans and Democrats can agree needs to end,” said Paul in a recent press release regarding the act. READ MORE.
Massachusetts Identifies Resistant Gonorrhea Strain
The Massachusetts Department of Public Health announced two cases of gonorrhea with reduced responsiveness to five different classes of antibiotics. The strain observed by health officials had previously been identified in multiple Asian countries and the United Kingdom, with these two cases representing the first identification of this strain in the US. Healthcare providers eventually cured the affected individuals using ceftriaxone delivered through intramuscular injection. READ MORE.
US Preventive Task Force Releases Recommendations
The leading body in charge of designing preventive care best practices in the US has released new recommendations based on introductions from 2022. The organization will recommend anxiety screenings for children eight and older. Additionally, the organization gave depression risk and suicide screenings in children 12 and older a passing grade. Both recommendations were assigned a B grade, suggesting practitioners adopt the screenings for suitable patients because of their moderate effectiveness. READ MORE.
DOJ Investigates Abbott Laboratories
According to Wall Street Journal reporting, the Abbott Laboratories facility that was at the center of a nationwide baby formula shortage now faces a DOJ consumer-protection branch investigation. Abbott voluntarily recalled its Similac baby formula last year after several babies became ill with bacterial infections. A further FDA inspection of the Abbott facility in Michigan revealed critical issues that were later remedied. READ MORE.
