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
Congress delivered a significant Christmas present to President Trump this week and to industry by enacting landmark tax reform legislation that makes major changes in the corporate tax structure. The result may be billions in savings for multi-national biopharma companies. In addition to lo Powered by WPeMatico Continue reading Tax Overhaul: A Plus for Pharma
Despite FDA approval of seven biosimilars through October 2017, only three have come to market due to heated patent disputes and continued debate over biosimilar naming and interchangeability. Innovators maintain the need for distinct names to facilitate postmarket identification and tracking of Powered by WPeMatico Continue reading Common Ground on Biosimilar Coding
Agency leaders go slow in weighing changes to DTC ads and off-label marketing. FDA regulation of prescription drug and medical product promotion has come under fire in recent years, as federal courts have supported industry challenges to rules limiting communications of unapproved drug Powered by WPeMatico Continue reading FDA Explores Flexible Drug Marketing Policies
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?
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
FDA is conducting in-house research to help evaluate whether limiting warnings in TV commercials to the most serious adverse effects might be more informative for consumers than the current laundry lists of potential side effects. A current study by FDA s Office of Prescription Drug Promotion (O Powered by WPeMatico Continue reading FDA Considers More Targeted Risk Information in DTC Ads
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval. The hope is that a clear process for develo Powered by WPeMatico Continue reading Will Interchangeability Boost Biosimilar Prescribing?
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
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