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FDA 2017 Year in Review: Therapeutic Products, Part 2

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’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year’s new drug … Read more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

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 this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected … Read more

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

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 followed on the heels of a July 18th hearing in which officials from the Health Resources and Services Administration (HRSA), the Government Accountability Office (GAO), and the Department of Health … Read more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

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’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” The short version is that the Agency will: Step up … Read more

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

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 Oversight since March 2015.  A common thread ran through the testimony of the three testifying witnesses:  Erin Bliss, Assistant Inspector General with HHS-OIG; Dr. Debra Draper, Director of Health … Read more

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

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 340B drugs “so that government safety net programs share in 340B savings.” I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered … Read more

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

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 debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the … Read more

FDA Commissioner Hints at Drug Pricing-Related Initiatives

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 upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical … Read more

California Advances PBM Licensing and “Transparency” Law

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 require PBMs to obtain licensure from the Board of Pharmacy, (b) to state that PBMs have fiduciary duties to their “purchaser” clients (i.e., health plans), and (c) to … Read more