Drug Pricing Dominates Senate Hearing on HHS Nominee Azar

If confirmed as the next secretary of the Department of Health and Human Services (HHS), Alex Azar says that a top priority is to make drugs more affordable. He agreed with members of the Senate Finance Committee at his confirmation hearing January 9 that drug prices are too high, but noted th Powered by WPeMatico Continue reading Drug Pricing Dominates Senate Hearing on HHS Nominee Azar

Can Streamlined R&D Reduce Drug Prices?

The recent FDA approval of the first chimeric antigen receptor T cell (CAR-T) therapy to treat young patients with a serious form of leukemia reignited charges that high drug prices limit patient access to life-saving medicines. Novartis announced that it would charge $475,000 for treatment with Powered by WPeMatico Continue reading Can Streamlined R&D Reduce Drug Prices?

FDA, Manufacturers Strive to Prevent Drug Shortages from Hurricane Maria

The extensive volume of pharmaceutical manufacturing in Puerto Rico is driving FDA efforts to quickly assess facility damage and logistical problems to ensure continued supply of critical medicines. More than 20 companies, including Pfizer, Eli Lilly, Johnson & Johnson and Amgen, operate mor Powered by WPeMatico Continue reading FDA, Manufacturers Strive to Prevent Drug Shortages from Hurricane Maria

Drug Serialization for DSCSA Compliance Benefits Everyone

A minority of pharmaceutical manufacturers are on track to meet the next big Drug Supply Chain Security Act (DSCSA) deadline just around the corner. Although the FDA has announced it will delay enforcement until 2018, beginning November 27, 2017, pharma companies are required by law to serializ Powered by WPeMatico Continue reading Drug Serialization for DSCSA Compliance Benefits Everyone

FDA, Industry Prepare for New User Fee Initiatives

The Senate approved critical legislation early last month reauthorizing important five-year user fee programs that fund FDA review operations, just in time to avoid major agency disruptions. The bill was nearly derailed by contentious Senate debate over revising the Affordable Care Act (ACA), bu Powered by WPeMatico Continue reading FDA, Industry Prepare for New User Fee Initiatives