Scott Gottlieb

When Is "Milk" Not Milk? The FDA Will Soon Decide

FDA Commissioner Scott Gottlieb said the FDA is considering limiting plant-based dairy alternatives from being branded as "milk."<p><b>UPDATE</b>: After …


FDA commissioner: “An almond doesn’t lactate”

Thanks to Food And Drug Administration commissioner Scott Gottlieb, I am now haunted by the image of an almond with tiny, tiny udders. Thanks for …


FDA chief says pharmas use rebates to block biosimilar competition

WASHINGTON -- Food and Drug Administration Commissioner Scott Gottlieb Wednesday blamed pharmaceutical companies for manipulating rebates to stymie …


FDA Defends Decision To Reclassify Alternative Milks As ‘Nut Sweat’

SILVER SPRINGS, MD—Addressing concerns that the naming practice could unfairly bias consumers against the products, the U.S. Food and Drug …


FDA plans to crack down on alternative ‘milk’ products

Got milk? Maybe not.<p>Federal regulators signaled this week they intend to crack down on non-dairy products billing themselves as “milk” — reversing a …


Gottlieb: Some price hikes needed for basic drugs in short supply

FDA is exploring whether to create a list of essential medicines vulnerable to shortages and give manufacturers pricing flexibility to keep those drugs in stock, Commissioner Scott Gottlieb said Tuesday.<p>Drug shortages are not a new problem, but low prices and industry consolidation have squeezed …

U.S. Politics

FDA Recalls Some Valsartan Drugs Due to Impurity

Product Recalls

Here's A Bizarre Medical Scam That Even The FDA Can't Figure Out

People who buy medicines from illegal online pharmacies have started receiving frightening letters in the mail: official-looking notices from the …


Cultivating a vibrant U.S. market for biosimilars: A conversation with FDA’s Scott Gottlieb

Biologics, drugs manufactured thorough the techniques of modern biotechnology, represent a large and growing share of the U.S. drug market and offer …

Health Care

FDA enlists help from big tech to clamp down on internet opioid sales: Dr. Scott Gottlieb

Dr. Scott Gottlieb, FDA commissioner, discusses how the Food and Drug Administration (FDA) is trying to get ahead of the national opioid epidemic by …


No Guidance on Right-to-Try Drugs for Months, FDA Chief Says

It will be another two to three months before the FDA releases guidance or information for drug manufacturers about the nation’s new right-to-try …


Go Figure

This politician says his country will do whatever is necessary to reassure consumers who have been affected by rising oil prices. Name the …


FDA's Gottlieb calls out big pharma on blocking competition

FDA Commissioner Dr. Scott Gottlieb, talks about how branded companies are making it harder for generics to make it to market and his plans to bring …


FDA website to post names of drug makers blocking development of cheaper generics

The FDA plans to unveil a website today naming pharmaceutical companies that have blocked the development of generic drugs by failing to provide samples to competitors. This public posting is part of FDA Commissioner Scott Gottlieb's larger crackdown to, as he says, “end the shenanigans” by brand …

Generic Drugs

FDA Commissioner Gottlieb on lowering drug prices

Dr. Scott Gottlieb, FDA commissioner, discusses the White House’s plan to lower drug prices.

The White House

There's an EpiPen shortage, says allergy group

Consumers with food allergies in as many as 14 states have had trouble filling prescriptions, according to Food Allergy Research and Education (FARE).<p>…

Food Allergies

Obama-era calorie count requirement goes into effect

The Food and Drug Administration is implementing an Obama-era law that requires food establishments with 20 or more locations to post calorie …

Affordable Care Act

The Great Debate: What is Enough... Women in Clinical Trials

Join the FDA Office of Women’s Health for The Great Debate! Featuring Ellis F. Unger, M.D., FDA CDER, and Rita F. Redberg, M.D., M.Sc., F.A.C.C., the …

Clinical Trials

STAT Plus: FDA could convene second advisory panel to re-examine safety of Acadia Pharma drug

Acadia Pharmaceuticals’ (ACAD) share price has flagged since an April story by CNN that highlighted serious and sometimes fatal side effects tied to …


FDA Goes All Out With Digital Health Regulatory Paradigm Shift

From the launch of a premarket digital safety program, to the release of new policies for multi-function device products, FDA Commissioner Scott …

Digital Health

Acadia shares plunge on report FDA is re-examining its drug

Acadia Pharmaceuticals shares plunged 22 percent Wednesday after a report the Food and Drug Administration will re-examine its only drug.<p>Nuplazid, …


What’s Scott Gottlieb Up to at the FDA?

Mike Riggs finds out.<p>return-icon Return to The Corner

Conservative View

C-SPAN: FDA Commissioner Scott Gottlieb Talks To KHN

Kaiser Health News reporter Sarah Jane Tribble sat down with Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, on C-SPAN’s …


FDA chief: Opioids are biggest crisis we face

FDA commissioner Dr. Scott Gottlieb tells CNN's Dr. Sanjay Gupta that opioids are the "biggest crisis" facing the FDA and that tobacco and e-cigarette use among youths must be curtailed.

Public Health

A mysterious, popular 'supplement' has been linked to salmonella — and the FDA has issued its first mandatory recall

The Food and Drug Administration calls it a dangerous opioid, but kratom advocates call their pill of choice a life-saving supplement. Either way, it has been linked to a growing salmonella outbreak and, most recently, has spurred the FDA to issue its first mandatory recall.<p>Kratom is a psychoactive …


FDA Recalls Kratom Products For Salmonella Threat

Environmental Health

Podcast: FDA And Scott Gottlieb On Drug Trials, Nicotine, And Opioids

Mike Riggs, reporter at Reason Magazine, writes on drugs, the FDA, substances, and criminal justice reform. Riggs joins this episode of The …

Conservative View

The Sugar and Fiber Sections May Be Changing on the New Nutrition Labels

The F.D.A. wants to clarify a couple things when it comes to added sugar and total fiber on the newly designed nutrition facts labels rolling out in …


FDA working on policies to boost biosimilars

Reuters reports that the FDA is working on "about a dozen" policies aimed at making it easier for biosimilars to gain a foothold in the U.S. …


White House could be blowing smoke with plan to cut nicotine in cigarettes

It looks like the Trump administration has finally found a business it doesn't like.<p>Amid a far-ranging push to deregulate American companies — from payday lenders to internet service providers — Trump has singled out Big Tobacco as the one industry he intends to crack down on.<p>Last week, the Food …