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Read need-to-know updates, commentary, and analysis on Elections & Politics issues written by leading professionals.

Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care—the First 100 Days

by Ropes & Gray LLP on

On Tuesday, May 2, Ropes & Gray hosted a teleconference, “Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care – the First 100 Days,” on the potential regulatory and...more

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

Under the Dome: Inside the Maine State House

by Pierce Atwood LLP on

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Spokesperson Says Governor Paul LePage Will Not Seek Senator King’s U.S. Senate Seat - A...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

How Will the Appointment of a Special Counsel Affect the Administration's Regulatory Agenda?

by Mark Mansour on

The news of the the appointment of Robert Mueller as special counsel to be investigate the Russia-Trump connection rocked Washington. The immediate concern was how the White House would surmount the distraction and where all...more

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more

Senate Confirms Dr. Gottlieb's Nomination as FDA Commissioner

by Jones Day on

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and was...more

Congressional Panels Tackle FDA Reauthorization Act and Other Health Policy Issues

by Reed Smith on

On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and...more

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Dumping Medicine: Make Sure Pharmaceutical Wastes Aren’t Left Behind By Regulatory Reform

Regulatory reform has dominated the Trump administration’s environmental policy agenda to date, fueled by Executive Orders requiring agencies to identify unnecessary regulations for revision or outright rescission, and to...more

Congress boosts NIH funding but CDC, drug czar’s office aren’t faring as well

Although its battles over health insurance have dominated the headlines, Congress also provided a glimmer of good news on funding for medical research. Lawmakers, at least for this fiscal year, shunned President Trump’s...more

Complicated Landscape Awaits New FDA Commissioner

by Holland & Knight LLP on

A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more

Senate Confirms New FDA Commissioner

by Snell & Wilmer on

Dr. Scott Gottlieb was confirmed today as the new FDA Commissioner. Dr. Gottlieb has promised to put public health first and not do anything “that shakes the public’s confidence in the agency.” He is a former hospitalist who...more

2017 Omnibus Agreement: Key Health Provisions

by Polsinelli on

Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more

FY2018 Massachusetts Budget Update: The House Budget

On April 25, 2017, the Massachusetts House of Representatives passed a $40.829 billion FY2018 budget by vote of 159-1. Over two days of debate, the House considered 1,210 amendments to pass a final budget that spends...more

Latest Developments from the Connecticut General Assembly: The Education Committee Has Spoken - May 2017

We had written earlier about the proposed bills that the General Assembly’s Education Committee voted favorably on and advanced out of committee at its March 8, 2017 meeting. The Committee subsequently voted favorably on a...more

GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies....more

Medical Device Excise Tax Remains in Limbo

President Trump and Paul Ryan (R-Wis) have not yet successfully replaced the Affordable Care Act with the American Health Care Act (“AHCA”). The medical device industry had been paying particular attention to the proposed...more

Canada expands protection of individual rights with new legislation on genetic testing and privacy

by DLA Piper on

Significant legislative changes are on the horizon in the field of genetic testing with Parliament’s recent passage of Bill S-201: An Act to Prohibit and Prevent Genetic Discrimination (“Act”). The Act will implement broad...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...more

Health Care Weekly Preview from ML Strategies – April 2017

Welcome back everybody. While the momentum around an American Health Care Act (AHCA) comeback is unclear, there’s no discounting that efforts are ongoing to reach a consensus among House Republicans with significant pressure...more

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

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