Gottlieb Signals Depth and Scope of Changes Coming to Drug and Device Approvals in FY 19 Budget Comments

On April 17, 2018, FDA Commissioner Scott Gottlieb appeared before the U.S. House Subcommittee on Agriculture, Rural Development to discuss the Fiscal Year 2019 budget request for FDA. He began by touting the broad achievement in record approvals last year…

Healthcare Expectations for 2018

2017 was arguably one of the most monumental – and consequential – years for the healthcare industry in recent memory. And 2018 looks to be just as active across a number of areas – from business development in the biopharma…

The Rapid Pace of Change at FDA in 2018

As 2017 began, there was change in the air for FDA if for no other reason than the passage and implementation of the 21st Century Cures Act (Cures) which succinctly put, stood for the principle of enhancing and speeding innovation.…

These 3 Things Have Us Excited for the Healthcare Industry in 2018

Predicting the future is a tricky business. Still, investors, analysts, public and private companies and journalists will soon peer deeply into their crystal balls to forecast the year ahead for the healthcare industry. The forecasting is part of an annual…

From Stealthcare to Healthcare? A FleishmanHillard Policy Discussion

Since the enactment of the Affordable Care Act in 2009, there ensued a profound sense of déjà vu as Republican members of Congress tried to undermine the law through court challenges as well as through repeated attempts to vote a…

The FDA Welcomes A New Commissioner: What Will Dr. Gottlieb Do?

Mark Senak contributed to this article. Dr. Scott Gottlieb, the newly appointed commissioner of the U.S. Food and Drug Administration (FDA), has taken the lead of an agency that regulates one-fifth of the economy and oversees two of Americans’ most important…

Selling TrumpCare: Be Careful What You Promise

Having finally rolled out its legislative proposal to repeal and replace the Affordable Care Act, President Trump and the Republican leaders in Congress are scrambling to corral enough support to get the American Health Care Act (AHCA) through both houses…

New Year, New Administration, New FDA and New Cures: Approvals and Enforcement Outlook for 2017

Every U.S. federal agency is facing the potential for considerable change given a new Administration taking office this month, setting into motion the process whereby new heads of bureaucracies assume responsibility and bring different priorities and agendas to their respective…

Four Reasons Why Obamacare Won’t Be Repealed In Trump’s First 100 Days

How Will Healthcare Fare in Trump’s First 100 Days? Ever since Franklin Roosevelt succeeded Herbert Hoover in the White House, the nation has focused tremendous attention on a new president’s first 100 days. As Donald J. Trump prepares to take…

These are Three Storylines We’re Watching at the J.P. Morgan Healthcare Conference

It’s that time of year again. We’re days away from the annual J.P. Morgan Healthcare Conference in San Francisco. All eyes will be on this gathering of the world’s biotechnology start-ups, pharmaceutical companies, medical device manufacturers, and health insurers. And…

What's Next for 21st Century Cures Act?

The 21st Century Cures Act has been long in the making. First passed by the House of Representatives as in July 2015 by an overwhelming vote of 344 – 77, the bill hit the legislative wall in the Senate where,…

The Coming Battle Over Medicaid

President-elect Trump’s promise to convert the Medicaid program into a state-run block grant has tremendous implications for low-income and disabled Americans and their families. It can also have significant impact on key parts of the healthcare industry including the insurance,…

President-Elect Trump & Healthcare

So the election-with-no-end is finally over and the nation is starting to sort out what the results will mean for a wide range of concerns including healthcare. While the candidates staked out very different positions, they spent very little time…

Let’s Play Fantasy Baseball, Cabinet Version

I have never quite understood the allure of fantasy sports. Picking players from different teams based on past performance and your hunch of how they might play in the future on a team you create seems boring to me. As…

The Best of Cannes Lions Health: Smart Ideas, Well-Executed

The sheer volume of inspiring and excellent work shared at this year’s Cannes Lions Health has been remarkable—from breathtakingly beautiful films to stunning works of art and fantastically creative social campaigns. As I watched the awards ceremony presentations, I had…