Science, Computers & Technology Health Elections & Politics

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HHS and Medicare Asked to Expand Coverage for Genetic Tests

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...more

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

President’s budget ax takes a big whack at medical, scientific funding

The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more

Key Takeaways From FHA’s Health Law Summit

Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state...more

NC Legislative Update - March 2017 #2

This Week - Final arguments were heard Tuesday for litigation brought by Gov. Cooper (D) over the legality of legislation passed late last year creating the Bipartisan State Board of Elections & Ethics Enforcement...more

The Uncertain Future of the 340B Drug Discount Program

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more

Republican Healthcare Bill Would Leave BPCIA Untouched

In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more

BPCIA Appears Unaffected by Proposed New Healthcare Law

On Monday, March 6, House Republicans unveiled their plan to repeal and replace the Affordable Care Act (“ACA”). Although the proposed legislation repeals or amends several provisions of the ACA, based on a preliminary...more

What’s in store for the Affordable Care Act and drug pricing policy under the Trump administration?

The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled Congress to begin rolling back key provisions of the legislation. The promised...more

Big Pharma enlists more useful allies: pay-for-hire academic economists

It’s a $50-million business with a roster of blue-chip consultants who would be an envied faculty at most any major university. But look closely at the activities of Precision Health Economics because this firm’s esteemed...more

Under the Dome: Inside the Maine State House

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Clean Election Funding for Gubernatorial Candidates Being Challenged - Maine’s Clean Election...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

China’s State Council Announces Major Policies to Reform the Pharmaceutical Industry

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #2

Governor’s $35 Million Housing Bond Discussed in Ways and Means Committee - Executive Director Gus Selig of the Vermont Housing and Conservation Board revealed some of the details this week behind the $35 million bond...more

Health Care E-Note - Februaury 2017

Ransomware: A Reportable Breach? In the past several years, a huge increase has occurred in the number of electronic attacks in the United States using ransomware, a form of malware that targets and encrypts critical...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017

The Agency of Transportation has submitted a proposal to the House Transportation Committee that would allow the agency to seek damages from a utility that fails to move or adjust a utility line that is in a state or local...more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

As patients sue over insulin’s skyrocketing costs, Trump thunders, confuses

Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more

Life Sciences. Major Russian legislation changes for 2016

We would like to present the overview of the most important legislation changes in life sciences for 2016....more

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

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