On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading
On September 26, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease or condition or fill an … Continue Reading
Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health data or … Continue Reading
Joan Kutcher and Gary Heimberg delivered remarks during Covington’s post-election conference call with clients on November 8, 2018 on health care and drug pricing. The health care segment follows: The Affordable Care Act has been an issue in every election since it passed in 2010. This election was the first time the Democrats could fully … Continue Reading
Today, the President will submit the Administration’s Fiscal Year 2019 budget blueprint to Congress. The document will set in motion an annual process to analyze the substance, business implications and prospects for various proposals. Draft documents have already begun to circulate that suggest that both the budget and a forthcoming addendum would, if enacted, have … Continue Reading
On January 20, 2017, President Donald J. Trump signed an Executive Order instructing federal agencies to work to “minimize the unwarranted economic and regulatory burdens” of the Affordable Care Act (“ACA”), and to increase the flexibility provided to States to run healthcare programs. While the Executive Order itself does not change any regulation or specific … Continue Reading
It is safe to observe that modifying or repealing the Affordable Care Act (aka as Obamacare) will be the top health care-related priority of the Trump Administration. Trump spoke about repeal and replace often — he even called for a special session of Congress to repeal it — and while it was not among his … Continue Reading
This year, titans of business, government and society face a near tidal wave of anxiety-provoking events and trends in “The New Global Context” they will discuss this week. Rather than upbeat discussions of start-ups and breakthroughs, they will confront some of the world’s most intractable issues just as global events highlight the failure of sufficient … Continue Reading
In what many consider to be an unusual move, the Supreme Court agreed to hear a high-stakes case about the legality of premium subsidies for low- and moderate-income individuals enrolling in health coverage offered under the Affordable Care Act (ACA). The Court will review a unanimous decision by a Fourth Circuit panel in King v. … Continue Reading
The mid-term election brings an historic changing of the guard in the health care leadership in Congress. Republicans will take control of the Senate in January and gain key chairmanships. Senior Democrats like Senators Harkin and Rockefeller, and Representatives Dingell and Waxman, who have been leaders on health policy issues for decades, are retiring. Congress … Continue Reading
During the African Leaders Summit in August, Brookings convened the panel discussion, “Africa’s Image and U.S. Perceptions in the 21st Century,” that included leading journalists and Africanists such as Helene Cooper of The New York Times, William Wallis of the Financial Times, Amadou Mahtar Ba of AllAfrica Global Media, John Prendergast of the Enough Campaign … Continue Reading
Well before Ron Klain was named as the U.S. Ebola czar, the USG was urging the international community to confront the fact that the world is not ready for a deadly pandemic of any sort, much less one as daunting as Ebola. Aware that Ebola alone could kill over 1 million people if international efforts … Continue Reading
The October 2014 Africa’s Pulse released by The World Bank confirms that economic growth in Sub-Saharan Africa continues to be strong. The average growth in the region is projected to increase to 5.2 percent during 2015-16 (up from 4.6 percent in 2014) and to 5.3 percent in 2017. Some markets and industries are looking to … Continue Reading
The Obama Administration has mobilized a number of government agencies to respond to the Ebola crisis in West Africa and to prevent its spread into the U.S. At the frontline of the Administration’s response is the Pentagon, the Department of Health and Human Services, the Center for Disease Control, the U.S. Agency for International development … Continue Reading
President Obama yesterday signed an Executive Order [1] (EO) directing Federal Government departments and agencies to take action at home and with international partners to combat this national security threat. The White House also issued its five-year National Strategy for Combatting Antibiotic Resistance [2] and the President’s Council on of Advisor’s on Science and Technology (PCAST) … Continue Reading
On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals. These guidance documents reflect FDA’s understanding of nanomaterials as … Continue Reading
Alarmed by the real health, economic and security risks associated with “superbugs” that are resistant to antibiotics — the lynchpins of modern medicine — President Obama has included antimicrobial resistance as a focus of his 26-nation partnership Global Health Security Agenda. He has just announced a September 2014 White House international conference that will highlight … Continue Reading
