Lietzan Examines SCOTUS Ruling on Biosimilars

In the latest post on the the IVI-sponsored Health Affairs blog series, Drugs and Medical Innovation, Erica Lietzan takes a look at the recent Supreme Court ruling on Sandoz v. Amgen, examining premarket patent litigation, patent resolution process, state law influence, and the impact of the SCOTUS ruling itself. Read the full article here.

2017-07-14T05:22:20-04:00June 19th, 2017|Viewpoints|

Examining Policies to Promote Development of Antimicrobial Drugs

In the latest post on the IVI-sponsored Health Affairs featured blog series, Seth Seabury and Neeraj Sood examine the challenges to addressing the significant threat that antimicrobial resistant infections pose to human health. In their commentary, Seabury and Sood focus on three of the most commonly proposed policies to promote the development of new antimicrobials: market [...]

2017-07-14T05:23:48-04:00May 18th, 2017|Viewpoints|

IVI’s Lakdawalla and Balch Participate in NPAF Consortium

On May 17th, IVI's Executive Director, Darius Lakdawalla, and Panel of Health Advisors member, Alan Blach, spoke at the National Patient Advocate Foundation's (NPAF) Spring 2017 Policy Consortium. The event launched the NPAF "Roadmap to Clarity in Healthcare Decision-Making." Both NPAF and IVI are committed to providing patients with accessible and useful information about the [...]

2017-07-18T22:27:19-04:00May 17th, 2017|Events|

Review of Key Provisions of FDA’s User Fee Reauthorization Bill

In the latest post on the IVI-sponsored Health Affairs featured blog series, Rachel Sachs addresses key provisions of the FDA's proposed user fee reauthorization bill. Included in her assessment are details of new language changes and amendments added to the bill, as well as a look forward to potential obstacles to the bill's final passage. Read [...]

2017-07-14T05:24:06-04:00May 15th, 2017|Viewpoints|

Lakdawalla, Sachs, and Bagley Focus on Medicaid’s Best-Price Rule and Trump Administration Opportunity to Advance Value-Based Pricing

In a recent post on the IVI-sponsored Health Affairs featured blog series, IVI's Executive Director, Darius Lakdawalla, along with Rachel Sachs and Nicholas Bagley, examine how Medicaid's best-price rule complicates the development of value-based pricing and suggest a potential solution that could come out of the new Trump administration CMS policies. Read the full article here. About [...]

2017-07-14T05:25:23-04:00April 27th, 2017|Viewpoints|

A Win-Win Strategy for Improving Access to Hepatitis C Medicines

In a recent post on the IVI-sponsored Health Affairs blog series, Neeraj Sood, Gillian Buckley, and Brian Strom present a novel "win-win" scenario for improving patient access to Hepatitis C medicines. By arranging for pharmaceutical patent holders to license their patents to the federal government, the agreement could potentially provide curative treatment to nearly a half [...]

2017-07-14T07:19:45-04:00April 24th, 2017|Viewpoints|

Rachel Sachs Summarizes Scott Gottlieb’s FDA Commissioner Confirmation Hearing

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 [...]

2017-07-14T07:20:20-04:00April 7th, 2017|Viewpoints|

Assessing the Landscape for Prescription Drug Regulation, Promotion, and Advocacy

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 [...]

2017-07-14T07:21:37-04:00March 23rd, 2017|Viewpoints|

The OPEN ACT as a Pathway to Accelerated Drug Development

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 [...]

2017-07-14T07:21:52-04:00March 21st, 2017|Viewpoints|

21st Century Cures Act and Lowered Confidence in FDA-Approved Drugs and Devices

In a recent post on the IVI-sponsored Health Affairs featured blog series, Deborah Mazer and Gregory Curfman focus on provisions of the 21st Century Cures Act that will impact the FDA's oversight of approved drugs and medical devices, including subtle changes to the approval procedures and a provision that permits-off label promotion of health care economic [...]

2017-07-14T07:24:00-04:00February 14th, 2017|Viewpoints|
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