FDA

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.

Childhood Cancer Measure Nears Bipartisan Win
Advocates had concerns over congressional, White House prioritizing Right to Try

Childhood cancer groups are pleased with the progress of the measure President Donald Trump is on the verge of signing. (Sarah Silbiger/CQ Roll Call file photo)

Groups who push for progress against childhood cancer see President Donald Trump’s imminent signing of a bill to enhance research in the field as a significant win after they grew frustrated with Congress and the administration’s pursuit of higher-profile legislation to expand access to experimental treatments.

The cancer legislation would let the Health and Human Services Department set up demonstration projects for childhood cancer survivors. Even after successful treatment, these patients can experience effects from their cancer, such as cardiovascular issues, intellectual handicaps and emotional trauma.

Health Officials Hit Back at Critics of Trump’s Drug Price Plan
As Democrats say the president’s plan is weak, Azar calls it a ”fundamental potential restructuring” of the American economy

Department of Health and Human Services Secretary Alex Azar, shown here at the White House last week, defended the president’s drug plan on Monday. (Sarah Silbiger/CQ Roll Call)

Top administration health officials on Monday defended President Donald Trump’s plan to address high prescription drug prices, which has drawn criticism from both the industry and those who see it as a capitulation to drug companies.

In a speech Monday in the foyer of the Health and Human Services Department, Secretary Alex Azar, a former pharmaceutical company executive, took direct aim at the industry. He said drug companies were offering the American people a false choice between the development of life-saving innovations and affordability.

Opinion: From the Vatican, a Challenge to Bring Promise to Patients
Conference urges support for innovations in science and medicine in a collaborative, safe and ethical manner

The Pontifical Council for Culture and the Cura Foundation hosted the “Unite to Cure” conference at the Vatican last month. (Courtesy the Cura Foundation/Unite To Cure: Fourth International Vatican Conference)

The power of medical research is rapidly moving from the lab to the patient.

Since the 21st Century Cures Act was passed in 2016, we’ve seen exponential progress in personalized, data-driven medicine and regenerative and gene therapies that will help prevent and treat disease, and even cure patients. Swift advances in science hold great promise for patients in need. At the same time, we must maintain our national standards for safety and ethical responsibility.

Trump Targets Drug Pricing in Trade Agreements
‘It’s unfair, it’s ridiculous and it’s not going to happen any longer’

Health and Human Services Secretary Alex Azar testifies during a Ways and Means Committee hearing on the FY2019 budget for HHS in Longworth Building on February 14, 2018. (Tom Williams/CQ Roll Call file photo)

President Donald Trump has instructed trade ambassador Robert Lighthizer to grant the drug industry’s wish of making pharmaceutical prices a “top priority” in negotiations with other countries.

Trump revealed the instruction during a Friday announcement unveiling the administration’s overall strategy for lowering drug costs.