Scott Gottlieb
STAT
Washington, DC, United States
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Past articles by Scott:
Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics
The FDA is currently working from an outdated regulatory playbook for diagnostic tests and cosmetics that has left gaps in its oversight of safety and effectiveness. → Read More
Intelligence agencies can help stop future pandemics. Here’s how.
We can’t rely on public health agencies alone. → Read More
The road to reopening won’t be a straight line
By Scott Gottlieb and Mark McClellan Since the lockdown orders of a year ago, Americans have made enormous sacrifices, complying with government guidance on masking and social distancing in hope of bringing about the trends we are finally seeing. Covid cases and hospitalizations are falling, and according to the White House, a majority of elderly Americans … → Read More
A light regulatory touch to keep COVID-19 drugs current
New variants of the Covid virus appear more infectious, and it’s urgent to get as much protective immunity into the population before these strains can take root. These new variants are evolving in ways that may allow them to slip past diagnostic tests, drugs and vaccines. The effort will require a new scientific and regulatory … → Read More
4 former FDA commissioners: Blood plasma might be the covid-19 treatment we need
But to make it work, we need a concerted effort to collect plasma and perform clinical trials. → Read More
Quarantining cities isn’t needed. But a fast, coordinated response to covid-19 is essential.
There is still time to implement tough mitigation measures that would reduce the scope of a nationwide epidemic. But that opportunity narrows with each passing day. → Read More
The world is better prepared for the coronavirus threat. But we remain tragically vulnerable.
We need to better understand the nature of this bug, and its severity. → Read More
The FDA got it partially right on e-cigs. Here’s what else needs to be done.
The new rules appear to have overlooked different devices that are gaining popularity with kids. → Read More
This is what the Trump administration should do on vaping
Get e-cigs out of the hands of kids but preserve the devices’ potential to help adult smokers fully quit cigarettes. → Read More
Scott Gottlieb: E-cigarettes are not off the hook
They still have potential benefits, but regulation has to come first. → Read More
Scott Gottlieb: The CBD craze is getting out of hand. The FDA needs to act.
The agency needs a regulatory framework for cannabidiol — and fast. → Read More
A Personal Tale Of ObamaCare Woe: One Patient's Story
This October 25, 2016 photo shows a woman looking at the Healthcare.gov internet site in Washington, DC. (KAREN BLEIER/AFP/Getty Images) A patient, I’ll call him John, is the kind of working class American that ObamaCare’s architects say that they fashioned their law to help. ObamaCare’s political disciples are dismissive of the tales [...] → Read More
How Congress Can Make Drug Pricing More Rational
The public reproach over the price of Mylan’s lifesaving EpiPen is the latest imbroglio in a much broader debate over drug costs. What's little understood is that the convoluted arrangement by which drugs are priced and sold arose accidentally as a result of litigation. Addressing the unanticipated consequences set by a 1996 court ruling could provide Congress with a simple way to improve… → Read More
A fair plan for fairer drug prices
Current regulation discourages the value-based purchasing of drugs, potentially stifling both competition and innovation. Sensible reform would adopt a market-oriented approach where drug prices reflect actual clinical outcomes. → Read More
New Evidence That Even Not-For-Profit Obamacare Plans Are Failing
The not-for-profit insurers that are planned to form the backbone of the Obamacare exchanges, including the Blues health plans, reported yesterday that they lost a lot of money in the first quarter of 2016. It was the same day that United Healthcare announced that it was pulling out entirely from [...] → Read More
FDA needs to change how it regulates novel technologies
FDA needs to take a more active approach to risk mitigation once products gain market entry, organizing this oversight based on the nature of the risk that it’ trying to resolve. → Read More
Why are some generic drugs skyrocketing in price?
In our economy for medicines, the dual principles of market-based rewards that attract entrepreneurship and deep value once patents have lapsed are longsta → Read More
Why Ebola Quarantines Will Grow Larger -- And More Troubling
The critical reckoning over forced quarantines is still to come. Consider this scenario. Sometime in January or February – as the Ebola epidemic explodes out of West Africa – we’ll start experiencing larger, more frequent outbreaks in American cities. With the flu as a background to confound suspected cases of Ebola, public [...] → Read More
In The Ebola Fight, A Defense Of Embattled CDC Chief Thomas Frieden
The response by public health officials and local providers to the first case of Ebola diagnosed on U.S. soil has been marked by some tragic missteps. Mistakes have resulted in the avoidable secondary spread of the infection to healthcare workers. This is an appalling outcome to a crisis that we expected. But, [...] → Read More
Can Ebola Go Airborne?
A study in the journal Science, released last week, shows that the Ebola strain spreading across Western Africa has undergone a surprisingly high amount of genetic drift during the current outbreak. Experts say the mutations could eventually make the virus harder to diagnose and perhaps treat with a new therapeutic, [...] → Read More