article thumbnail

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog

The government would require at least another 30 days to examine the shipment at the U.S. For example, the Canadian government reiterated its commitment to safeguard Canada’s domestic drug supply and has issued regulations to prohibit bulk exports to the United States that will cause or worsen drug shortages in Canada.

article thumbnail

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.