Health Law & Policy Matters

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space.  Part 1 recapped Commissioner Gottlieb...

https://www.healthlawpolicymatters.com/2017/12/19/fda-2017-year-review-therapeutic-products-part-2/

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In...

https://www.healthlawpolicymatters.com/2017/12/18/fda-2017-year-review-therapeutic-products-energized-cures-act-bold-leadership/

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing follo...

https://www.healthlawpolicymatters.com/2017/10/31/six-key-follow-questions-asked-congress-340b-hearing/

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA�...

https://www.healthlawpolicymatters.com/2017/09/05/fda-commissioner-announces-stem-cell-enforcement-shift-plans-develop-comprehensive-regenerative-medicine-policies/

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Ov...

https://www.healthlawpolicymatters.com/2017/07/25/witnesses-congressional-hearing-340b-urge-congress-give-hrsa-broader-regulatory-authority/

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for...

https://www.healthlawpolicymatters.com/2017/07/17/six-questions-answers-cms-recommended-changes-340b-medicare-reimbursement/

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious deba...

https://www.healthlawpolicymatters.com/2017/06/30/fda-stays-in-the-spotlight-with-drug-pricing-moves-but-could-be-facing-risk-as-ufa-bill-loses-attention/

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in ...

https://www.healthlawpolicymatters.com/2017/05/31/fda-commissioner-hints-at-drug-pricing-related-initiatives/

Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.  AB 315 seeks to amend the California Business and Professions Code: (a) to requi...

https://www.healthlawpolicymatters.com/2017/04/25/california-advances-pbm-licensing-transparency-law/

Welcome to Spring Break! That time of the year where college kids head to a beach somewhere, families pack up for some tourist trap to spend lots of money, and Congress gets out of DC and goes ba...

https://www.healthlawpolicymatters.com/2017/04/19/the-health-care-minibus/