FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 enforcement against stem cell “actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk.” To that end, Dr. Gottlieb also announced the creation ..read more
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Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 Care at the GAO; and, Captain Krista Pedley, Director of the Office of Pharmacy Affairs at HRSA:  Congress needs to legislatively grant HRSA more administrative a ..read more
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Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 entities’ acquisitions cost.”  And I noted that “the profits are especially steep for physician administered drugs” in Medicare Part B where reimbursement is set at Average Sales Price (ASP) plus 6%.  My authoriti ..read more
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FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” First, on June 27, 2017, the Agenc ..read more
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FDA Commissioner Hints at Drug Pricing-Related Initiatives
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 companies for the high prices of their products but has done little to advance concrete policies in this area. Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA ..read more
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California Advances PBM Licensing and “Transparency” Law
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 require PBMs to disclose to their purchaser clients data regarding drug costs, rebates, and fees earned. The favorable vote moves the bill to the Committee on Appropriations. California is not the only state that is considerin ..read more
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The Health Care Minibus
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
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 back home.  This is also a time to consider where we are and where we are heading in terms of health care policy.  We will continue to hear of potential policies aiming to unify Republicans on health care reform, but until we see substantive policy changes that get members to change their votes from the American Health Care Act, this is all talk.  However, there is a health care minibus co ..read more
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Some Useful Links for You to Get Started
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
It seems like you’re running a default WordPress website. Here are a few useful links to get you started: Migration How to use WordPress Migrator Plugin? Migrate WordPress from Siteground to Cloudways Migrate WordPress from GoDaddy to Cloudways General How do I take my website live from Cloudways? How to manage WordPress via WP-CLI on Cloudways? How to configure WordPress Multisite on Cloudways? How to access your databases on Cloudways? Performance How to install and configure Breeze WordPress cache plugin? How to integrate CloudwaysCDN with your WordPress website? How to configure WP Ro ..read more
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21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements. This directive to apply RWE in the drug sphere is particularly interesting because FDA has issued a draft policy on the use of RWE in the context of medical devices, but has generally remained silent about applying RWE to pharmaceutical and biol ..read more
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DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability
Health Law & Policy Matters
by Health Law Policy Matters
2y ago
The U.S. Department of Justice (DOJ) issued a  on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. Yates delivered additional remarks yesterday on the memorandum and its expected impact on criminal and civil investigations of corporations.  Having been publicly criticized for permitting corporations to take the fall and allowing individual wrongdoers off the hook, the DOJ has re ..read more
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