In a recent post on the IVI-sponsored Health Affairs featured blog series, Rachel Sachs summarizes Scott Gottlieb's FDA Commissioner confirmation hearing and top-lines four areas of questioning: the drug approval process, the character of the FDA, the opioid epidemic, and soaring drug prices. Also notable for not being mentioned, Rachel is curious how Dr. Gottlieb will address the FDA's relationship with [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Jonathan Silver suggests the key to lowering brand drug prices may be found through patent buyouts and changes to licensing policy. In particular, Silver proposes that non-profit entities be created and funded to purchase and license intellectual property rights for certain branded drugs. Read [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Daniel Blumenthal, Mark Linthicum (IVI Director of Scientific Communications), and Sachin Kamal-Bahl (Member, IVI Strategic Advisory Panel) discuss challenges in establishing outcomes-based pricing agreements for pharmaceuticals and potential strategies for overcoming obstacles. Strategies discussed include focusing on legal and regulatory changes, increased information sharing, [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, John Fox and Marc Waltrous provide a detailed analysis of the Genentech-Priority Health Pilot program, outlining the background, key considerations, pilot design, and take-aways to illustrate the challenges of a successful outcomes-based contracting agreement. Read the full article here. About the Health Affairs/IVI Featured Blog [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Tim Horn and Sean Dickson propose changes to the current system of drug pricing regulation focusing on four areas: Pricing formulas Price increase penalties Pool pricing guidelines Reporting transparency Read the full article here. About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Jerry Avorn sums up the status quo in medical regulation and evidence-based prescribing. Avorn uses his commentary to call out flaws in the 21st Century Cures Act, illustrate how the appointment of a new FDA Commissioner may influence "right-to-try" laws, and discuss the promise [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Max Bronstein, Emil Kakkis, David Fajgenbaum, and Chip Chambers address the current landscape of drug development, making the case for the OPEN ACT (Orphan Product Extensions Now, Accelerating Cures and Treatments), new legislation that would extend the exclusivity period for any drug repurposed for [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Robert Bohrer addresses the current system in place for the accelerated approval of novel drugs and notes the delicate issues that regulators are confronted with. Bohrer suggests that a new "conditional approval" approach may be the best compromise and provide a way forward. Read [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Sarah Rosenberg-Wohl and coauthors discuss the potential of private insurer funding for CER through "Coverage with Evidence Development," using the Wisdom Study as a real-world case study. Read the full article here. About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation -- In partnership [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Claire Laporte explains why the patent process dispute between biosimilar and branded drug manufacturers is headed all the way to the Supreme Court and why the outcome could influence intellectual property laws and protections for trade secrets. Read the full article here. About the Health [...]
