Tuesday, October 29, 2024

 

  • On Friday, three individuals in London were sentenced for their role in the international importation and distribution of unapproved drugs. The operation seized over £1M ($1.3M) and 1 million illicit pills. This result is the culmination of numerous law enforcement agencies, including the FDA Office of Criminal Investigations (FDA-OCI), working together from across the world for more than three years. The investigation began in October 2020 when U.S. Customs and Border Protection seized numerous shipments sent from the U.K. found to contain illicit drugs. Information sharing between FDA-OCI and the City of London Police led to the successful execution of warrants in the U.S., where illicit unapproved drugs were found.

Wednesday, October 16, 2024

 

 

Friday, October 11, 2024

 Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.  The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.


The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.

Friday, October 4, 2024

 The state of Texas is accusing major PBMs and drug companies of colluding to raise the cost of insulin. Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs, as Noah Tong reports.