FDA

FDA Plans Crackdown on Flavored E-Cigarettes
Move aimed at preventing nicotine addiction in young people

The FDA wants e-cigarette manufacturers to take steps to curb youth use or “face regulatory consequences.” (Matt Cardy/Getty Images file photo)

The Food and Drug Administration, seeking to prevent nicotine addiction in young people, plans to ban flavored e-cigarette sales in gas stations and convenience stores and will propose banning menthol flavoring in traditional cigarettes.

E-cigarettes and their liquid nicotine flavors would continue to be sold in dedicated vape stores, where the FDA believes age verification procedures are more reliable. Gas stations and convenience stores will be able to keep selling e-cigarettes and liquid nicotines flavored like tobacco and menthol.

HHS At Odds With Its Workers, Including Doctors
Employees plan to picket at HHS headquarters

A labor spat at the Department of Health and Human Services is drawing attention from lawmakers. (Bill Clark/CQ Roll Call file photo)

The Health and Human Services Department is in a dispute with a union representing 14,000 employees, which risks exacerbating staff shortages among doctors and scientists involved in prescription drug reviews, food safety and other public health responses.

The labor spat is drawing attention from lawmakers as some employees plan to picket at HHS headquarters briefly Thursday afternoon.

Drug Prices Could Become a Divisive Issue for Democrats
Internal tensions over Big Pharma could be on full display next Congress

Divisions among Democrats over the pharmaceutical industry could hurt their party’s efforts to address high drug costs if they win a majority next year. (Courtesy iStock)

Democrats are making the cost of prescription drugs a pillar of the party’s health care agenda in the midterms, but if they win a majority for the 116th Congress, the party will have to grapple with internal divisions over the issue that might be magnified next year.

This campaign season has been notable for candidates pushing the party to reject corporate influence. For emboldened progressive Democrats, the party’s current plans might not be enough. Their views compete with those of new candidates from politically moderate areas with a big pharmaceutical industry presence that might be more inclined to join with longtime incumbents who sympathize more with the industry’s perspective.

Hill Sends Big Chunk of Next Year’s Money to Trump, Minus His Border Wall
All eyes were elsewhere as House passed $855B measure for fiscal 2019

Speaker Paul D. Ryan says he’s confident the president will sign a widely supported spending bill. (Sarah Silbiger/CQ Roll Call)

As President Donald Trump gave a stem-winding press conference Wednesday on refusing to meet with the Canadian prime minister, getting laughed at by the United Nations, and what will happen to his embattled Supreme Court nominee, the House was passing legislation.

The chamber voted, 361-61, in favor of a measure that would allocate most of the fiscal 2019 appropriations that Congress controls, along with a continuing resolution to keep much of the rest of the government operating into December.

Trump’s FDA Takes on Tobacco
CQ on Congress Podcast, Episode 120

The FDA wants e-cigarette manufacturers to take steps to curb youth use or “face regulatory consequences.” (Matt Cardy/Getty Images file photo)

In an administration proud of its deregulatory approach, FDA Commissioner Scott Gottlieb has defied the trend. He's proposed to mandate lower nicotine levels in cigarettes and suggested a willingness to crack down on electronic cigarette products popular with kids. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, and CQ health reporter Andrew Siddons assess the proposals and the likelihood Gottlieb will follow through.

 

FDA Threatens to Stop Sales of Flavored E-Cigarettes
Agency gives companies 60 days to present strategy to curb youth use

The FDA wants e-cigarette manufacturers to take steps to curb youth use or “face regulatory consequences.” (Matt Cardy/Getty Images file photo)

The Food and Drug Administration on Wednesday announced it may force e-cigarette manufacturers to stop selling flavored products, citing what Commissioner Scott Gottlieb called an “epidemic” of youth use.

Five companies, including JUUL Labs, Inc., maker of the popular, USB-drive shaped device with nicotine flavors, will have 60 days to give the FDA a strategy on how they will curb youth use — “or face regulatory consequences,” Gottlieb said.

Ad War Over Drug Prices Goes One Step Forward, Two Questions Back
‘I undoubtedly will be sued,’ HHS chief Azar has predicted

Allies of the pharmaceutical industry, such as Sen. Orrin Hatch, R-Utah, have reservations about a plan to give HHS a green light on new regulations for drug price disclosure. (Bill Clark/CQ Roll Call file photo)

Updated 11:04 a.m. | A spending bill passed by the Senate last week includes $1 million for the Trump administration to craft new regulations forcing companies to include prices in prescription drug ads.

But there’s still the question of how that would work — and whether the Department of Health and Human Services has the legal authority to make drug companies disclose prices in TV, radio and other advertisements to consumers.

Senators Ask ‘What Is Milk?’
Dairy industry wants to limit the word to what comes out of cows

Sen. Mike Lee, R-Utah., wants clarity on milk, and what it is. (Bill Clark/CQ Roll Call file photo)

This morning senators asked themselves, “What is milk?” when voting on a proposal to block funding for a review of whether the word milk should be limited to products made from cow’s milk.

The Senate voted, 14-84, to defeat an amendment, offered by Republican Sen. Mike Lee of Utah, that would kill spending on a Food and Drug Administration study on what can be marketed as milk.

Durbin Back on the Warpath Against E-Cigarette ‘Candy-Flavored Poisons’
Introducing new legislation to make e-cig manufacturers show benefits

Sen. Richard J. Durbin has new legislation designed to curtail flavored e-cigs. (Bill Clark/CQ Roll Call file photo)

Senate Minority Whip Richard J. Durbin has launched a new offensive against a familiar foe: electronic cigarettes.

For years, the Illinois Democrat has been alarmed by the use of e-cigs by young adults — and flavorings that seem designed to appeal to kids, like gummy bear.

Opinion: To Keep Drug Costs Low, Think Competition, Not Price Controls
A robust, competitive market is the best way to promote innovation and reduce prices

If we truly want to reduce drug costs and make life-changing medications accessible to all Americans, we must increase competition among prescription drugs, Hatch writes. (Joe Raedle/Getty Images file photo)

Even in today’s highly partisan environment, there’s one thing nearly all Americans agree on: The soaring cost of prescription drugs is alarming.

In fact, 80 percent of Americans consider the cost of prescription drugs unreasonable. At the same time, a majority of Americans recognize that prescription drugs have improved countless lives. The president’s recently unveiled comprehensive blueprint to lower prescription drug costs has many ideas worthy of exploration. However, if we truly want to reduce costs and make life-changing and life-saving medications accessible to all Americans, we must increase competition among prescription drugs — particularly new drugs that have the ability to cure diseases, but face limited competition.