Even though Scott Gottlieb challenged FDA restrictions on truthful communications about regulated products as a private commentator on pharma policy, he is taking a more measured approach to expanding off-label promotion as FDA commissioner. A high-level FDA working group is taking a hard look Powered by WPeMatico Continue reading Drug Marketing and Advertising Under Fire
There s a mounting clamor for an end to the secrecy surrounding prescription drug pricing, promotional activities, regulatory decisions, and research findings. Stakeholders on all sides believe that more information on drug discounts and rebates is key to reining in payer and patient outlays for Powered by WPeMatico Continue reading Full Disclosure Demanded for Pharma Industry
Amidst all the outrage over surging pharma prices, the continued growth in generic drug prescribing has moderated overall spending on medicines, cooling the political heat on industry. Generics now account for nearly 90% of prescription drug use in the US due to policies facilitating their devel Powered by WPeMatico Continue reading More New Drugs and Generics Reshape Pharma Markets
It s taken a long time, but the European Union is at last trying to corral its numerous health technology assessment bodies into some form of standardization. The end of January is the scheduled release date for a legislative initiative that is likely to push the fifty or so national and regiona Powered by WPeMatico Continue reading European HTA is On Its Way At Last
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
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?
The steady rise in deaths, injuries, and treatment costs related to the abuse and misuse of opioid painkillers has increased calls for FDA and drug companies to more forcefully limit use of harmful medicines while ensuring access to effective analgesics for patients suffering from pain. With the Powered by WPeMatico Continue reading Pressure Mounts on FDA, Pharma to Tackle Opioid Abuse