On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more
On Tuesday, November 3, 2020, Americans chose the presidency and the makeup of the United States Congress. With the U.S. election now decided, with the exception of the Georgia Senate races, we are delighted to share with you...more
12/29/2020
/ 5G Network ,
Antitrust Provisions ,
Biden Administration ,
CFIUS ,
Coronavirus/COVID-19 ,
Foreign Investment ,
Healthcare Reform ,
Infectious Diseases ,
Infrastructure ,
Presidential Elections ,
Public Transportation ,
Regulatory Reform ,
Tax Reform
On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more
12/1/2020
/ Affordable Care Act ,
Biden Administration ,
Biotechnology ,
China ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Operation Warp Speed ,
Presidential Elections ,
Trans-Pacific Partnership ,
US Trade Policies ,
Vaccinations
The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more
President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug pricing reform efforts. These actions...more
Tuesday, 13 October 2020 -
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. President Trump and his aides on Friday...more
10/13/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medicaid Reimbursements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Trump Administration ,
Vaccinations
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
7/23/2019
/ Biotechnology ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Imports ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Working Groups
Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more
On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more
7/20/2018
/ Drug Distribution ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Legislative Agendas ,
Over-the-Counter Sales ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Oversight