FDA

Don’t do away with drug rebates.

Scott Gottlieb is Trump's "star" at the FDA who even has liberals singing his praises.

Trump’s FDA chief hasn’t been much in the news—and that’s a good thing.

Yes. Twenty-two people have already been affected.

A bill intended to clarify and alter a set of long-delayed Obamacare menu labeling rules passed the House Tuesday, as restaurant owners continue to prepare for a May 7 compliance deadline.

Once again officials within the FDA are proposing to put other interests over the needs of dying patients, predominantly children.

Once again officials within the FDA are proposing to put other interests over the needs of dying patients, predominantly children.

In March, Arizona became the first state to pass a bill allowing the free flow of medical information between drug companies and physicians. The Free Speech in Medicine Act, which was passed unanimously in both state houses, may seem curiously innocuous: It simply permits pharmaceutical companies…

Moments after the president's address to Congress concluded on Tuesday night, Vox ran the following headline: "The president is serious about dismantling the FDA to usher in more medical 'miracles.' That's wrong."

Last Friday the FDA decided to remove the black box warning it places on the smoking cessation drug Chantix. That the black box itself existed was a source of great frustration to me, because it represented the triumph of narrative over rational economic analysis. A few compelling stories,…

Controversial FDA rules for e-cigarette producers will badly damage the growing vaping industry. The regulations, finalized in August, require that any product not on the market before 2007—when there were no vaping products available—undergo a costly retroactive application process for federal…

President-elect Trump's team is being urged to kill new Food and Drug Administration rules that threaten to snuff out the e-cigarette business and rob chainsmokers of an alternative to ending their habit.

The 15 percent of American adults who still smoke cigarettes despite the well-known damage to their lungs, throats and lifespans are, it's fairly safe to assume, the stubbornest brand loyalists alive. And yet Philip Morris International (PMI), the maker of Marlboro, claims it's their new corporate…

When FDA officials can't agree, who gets the last say? For individuals afflicted with Duchenne muscular dystrophy (DMD), this question has had life-altering consequences, and the answer is still unclear.

When a government agency makes mistakes when doing a prescribed task, should Congress insist that it improve its performance, or simply tell it to dismiss the task altogether? When it comes to the FDA's Office of Criminal Investigation (OCI), we may soon find out.

Smoking rates have fallen appreciably in the last decade, driven by sharply higher cigarette taxes, public smoking bans, and changing mores that have made the activity basically unacceptable in many social circles.

In 2010, the New York Times dubbed her our "Quiet Savior from Harmful Medicines." That same year, FDA commissioner Margaret Hamburg presented her with the eponymous Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health. In 2000, she was inducted into the National…

As fans of My Big Fat Greek Wedding know, virtually anything worthwhile in life is very ancient and very Greek. My dad understood this, and was understandably surprised when he walked into a rheumatology conference several years ago to be confronted by a flashy display featuring "newly approved"…

In his last State of the Union address, Barack Obama asked, “How do we make technology work for us and not against us?" This was one of Obama's four "big questions" during his speech, and the audience cheered as he asked it—for good reason. It echoes the fears of regulators everywhere.

If Congress has any self-respect or desire to preserve its own prerogatives, it needs to overturn the FDA's new proposed regulations on e-cigarettes.

There's a "demotivational" poster that reads, "Mistakes: It could be that the purpose of your life is only to serve as a warning to others."

Think back to the Ebola chaos of last year. Nobody except the caregivers came away looking good​—​not the White House, not the Department of Health and Human Services, not the World Health Organization, not Congress, not most of the media.

Marina Koren at Government Executive writes that the Food & Drug Administration recently “sent a warning letter to the makers of Just Mayo, a vegan mayonnaise spread."

From Brussels to Chicago to the headquarters of the Food and Drug Administration in White Oak, Maryland, public health officials, antismoking crusaders, and mayors are waging a battle against flavorings for both tobacco cigarettes and newer e-cigarettes. 

In all the hubbub around the Supreme Court’s big end-of-session rulings on same-sex marriage and Obamacare, some high-level banana-republicanism was overlooked. The FDA has given American food manufacturers three years to get the “trans fat” out of their food. Trans fat, as you may know, is a type…

The Obama administration on June 2 convened the White House Forum on Antibiotic Stewardship, “to bring together key human and animal health constituencies involved in antibiotic stewardship.” The White House billed this meeting—to which more than 150 companies were invited—as furthering previous…

The FDA will seek to change the ban on gay men's blood, so long as the donor hasn't had sexual contact in the last year. 

The Food and Drug Administration (FDA) recently solicited quotes from contractors to recruit minors ages sixteen and seventeen to purchase "regulated tobacco products" on the Internet. The purchase attempts must be made from a facility located in Virginia and shipped to a P.O. Box provided by the…

In the froth and frenzy surrounding Ebola reaching America, a surprisingly unprepared Department of Health and Human Services, particularly the Centers for Disease Control, largely failed to rise to the challenge. The FDA contributed to, and continues to contribute to, that lack of preparedness.…

There isn’t much left in life that is unregulated and without some degree of government supervision or protection. You get used to it, I suppose. And, anyway, you don’t have much choice. But you do need to pay attention because nothing is off limits.

If you like going out in the sun or, perhaps, must do so because of your work and you don’t want to get burned, there is good news. Of a sort.  

Politics at its best brings people and groups together in unexpected ways. Although the Reagan administration responded sluggishly to the emergence of HIV in the 1980s, its last FDA commissioner, Frank Young, reached out to the very HIV activists who had for years made life miserable for him and…

The Food and Drug Administration is soliciting information and comment on brochure technology it's exploring as part of its mandate to implement the Tobacco Control Act, a law signed by President Obama during his first year in office.

First Lady Michelle Obama wants to make changes to the Nutrition Facts label. It is all "part of an effort to help families make healthier choices," according to the White House.

The Food and Drug Administration is seeking a small business to potentially supply the federal agency with a chewing gum tester.  Despite the frivolous sounding nature of the announcement, the search is a serious one, and apparently a growing need.  Chewing gum-based pharmaceuticals (such as…

It’s difficult to think of a company doing anything as gee-whiz neat as 23andMe. The Mountain View, Calif., firm, which opened its doors to the public in 2007, provides comprehensive genetic tests to anybody with $99 to spend. Customers send in a saliva sample and about six weeks later get access…

Smokeless, odorless, and, indeed, tobacco-less, electronic cigarettes, or “e-cigarettes,” in common parlance, are projected to become a $1 billion industry this year. Yes, that’s “electronic” cigarettes: battery-powered gadgets that convert liquid nicotine into vapor, which the user inhales. The…

The Food and Drug Administration's Office of Criminal Investigations is soliciting bids for "Data Mining and Targeting Software" to help in its efforts to combat illegal trafficking in cigarettes and other tobacco products.  The announcement appeared Monday on the federal government's fbo.gov…

The federal government will now allow companies that sell "nicotine replacement therapy (NRT) products," such as Nicorette, not to put warning labels on their merchandise, the Food and Drug Administration announced. The change, the FDA now admits, is because the warnings, which were mandated for…

The FDA is raising hackles over the equivalent of an espresso shot in a bottle: the popular 5-Hour Energy drink that has billions of dollars in sales over the past decade.

"The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune…

Last Friday, I noted that the Obama administration FDA was set to carry out a ban on asthma inhalers over environmental concerns because the propellant in them contains greenhouse gases. I thought that this was notable given that the Obama administration had recently stopped itself from…

The Obama administration is after your Lucky Charms, or at least your children’s. The public comment period closed on July 14 for a set of “voluntary” guidelines for the marketing of food to children. If adopted, these rules will transform the advertising of breakfast cereals.

What if you passed a regulation, and nobody cared? Obesity is quickly emerging as a major policy issue, with related health costs consuming 10 cents on every health dollar – and rising. Policymakers, then, are eager for ideas. Top of the list: regulations to force chain restaurants to post calorie…

Today, the Senate is likely to vote on the Food Safety Modernization Act of 2010 (S510). But the bill is little more than an enormous grant of money and power to the Food and Drug Administration and a lot of reporting burdens imposed on the private sector. Those who favor a smaller, leaner…