FDA

New FDA cigarette labels include realistic images of smoking-related health problems
The long-delayed warnings, now subject to public comment, would update textual statements already on cigarette packs

Examples of the new Food and Drug Administration warnings on packs of cigarettes. The warnings would update the textual statements already on cigarette packages, and for the first time include photorealistic images that depict smoking-related health problems. (Courtesy/FDA)

The Food and Drug Administration on Thursday proposed long-delayed graphic health warnings for cigarette packages, taking a step toward fulfilling a requirement of a decade-old smoking prevention law.

The new warning label proposal will now be subject to a public comment period, and is under a court-ordered deadline to be finalized by March 15, 2020.

HHS outlines drug import plans as Canada ratchets up concern
Canadians are worried that drugmakers could try to raise prices on the drugs sold there

Health and Human Services Secretary Alex Azar, who was previously skeptical of importation, now says it is more feasible than ever before. (File photo by Bill Clark/CQ Roll Call)

The Trump administration on Wednesday announced plans to help states and others import lower-cost drugs from Canada, a popular but controversial idea that President Trump has embraced but that the Canadian government has pushed back on.

The plans outlined Wednesday will offer guidelines for setting up drug importation programs, but they also highlighted the challenges of this approach to lowering drug prices for consumers in the United States.

‘Enter hemp with extreme caution,’ Kentucky farmer tells Senate panel
Agriculture Committee hears about the lows induced by hemp production

Senate Majority Leader Mitch McConnell says he hopes a new generation of Kentucky farmers finds hemp just as lucrative a crop as tobacco once was. (Bill Clark/CQ Roll Call)

Farmers facing low prices and mired in trade uncertainty see hemp as the next big cash crop, but a Kentucky veteran of six hemp harvests warned it’s a demanding plant to produce.

“Enter hemp with extreme caution,” Brian Furnish told the Senate Agriculture Committee on Thursday.

Juul under continued scrutiny over flavors, marketing tactics
Juul officials will appear before panel Thursday and will likely address Wednesday allegations

Sen. Richard Durbin, the bill sponsor for preventing the sale of flavored e-cigarette products said that raising the age of tobacco purchasing 'isn't enough.' The popular e-cigarette Juul is under scrutiny for appealing to young people through e-cigarette flavors.  (Caroline Brehman/CQ Roll Call)

The popular e-cigarette Juul is under renewed scrutiny by Congress thanks to two days of hearings that could pressure lawmakers to act on e-cigarette flavors that appeal to young people.

On Wednesday, the House Oversight and Reform Economic and Consumer Policy Subcommittee heard from witnesses about the company’s efforts to attract some vulnerable populations, namely teenagers and American Indians.

Papaya outbreak highlights FDA’s food safety challenge
‘Inability to track and trace foods with speed or precision’ is agency’s ‘Achilles’ heel’

Salmonella infections caused by contaminated papayas highlight the challenges Food and Drug Administration officials face in fighting foodborne illness. (Al Drago/CQ Roll Call file photo)

Salmonella infections caused by contaminated papayas highlight the challenges federal officials face in fighting foodborne illness, as a law from nearly a decade ago meant to modernize the food safety system is starting to show its age. 

The Food and Drug Administration is trying to bring its efforts to track and prevent outbreaks in line with the technology now at its disposal. But because spending for next year is uncertain, Congress could make it difficult for the agency.

Debate on e-cigarettes lights up 10 years after FDA tobacco law
Calls grow for agency, Congress to do more after spike in teen use

Florida Rep. Donna E. Shalala says Congress must update the 2009 law that gave the FDA the authority to regulate tobacco products. (Tom Williams/CQ Roll Call file photo)

A decade after Congress gave the Food and Drug Administration the authority to regulate tobacco products, there is a growing sense that the law should be revisited to address a product that lawmakers barely knew about in June 2009: electronic cigarettes.

The tension lies in how to balance e-cigarettes’ potential benefits with their clear risks. While e-cigarettes may offer a less harmful alternative for adults who smoke combustible cigarettes, they can appeal to young people who never would have smoked.

Lawmakers put funding ban on human embryo gene editing research in Ag. bill
The rider bars the Food and Drug Administration from approving research that involves gene-editing of human embryos

From left, Reps. Hal Rogers, R-Ky., Robert Aderholt, R-Ala., and Jeff Fortenberry, R-Neb., attend a House Appropriations Committee markup of the FY 2019 Homeland Security Appropriations Bill in Rayburn Building on July 25, 2018. By voice vote, the House Appropriations Committee adopted an amendment by Rep. Robert B. Aderholt, R-Ala., to put back language banning the funding of research involving the gene editing of human embryos, which has been in the spending bill since fiscal 2016. (Tom Williams/CQ Roll Call file photo)

Appropriators did some soul searching Tuesday before deciding to include a policy rider in the fiscal 2020 Agriculture spending bill that would bar the Food and Drug Administration from approving research that involves gene-editing of human embryos.

By voice vote, the House Appropriations Committee adopted an amendment by Rep. Robert B. Aderholt, R-Ala., to put back language that had been in the spending bill since fiscal 2016 but was omitted in the draft bill approved on May 23 by the Agriculture Appropriations Subcommittee.

The USDA violated rules trying to move agencies out of D.C., new House report finds
Rules including reprogramming department funds and not seeking public opinion were violated, a House Appropriations report says

Department of Agriculture sign in Washington, DC (Bill Clark/CQ Roll Call file photo)

In its drive to move two research-related agencies out of Washington, the USDA violated rules for reprogramming department funds, never sought public opinion and ignored appropriators’ request for a cost-benefit analysis, according to a House report released Monday.

The report, which will accompany the draft fiscal 2020 spending bill for the Agriculture Department, offers background on why lawmakers included provisions in the bill to bar the use of appropriated funds for moving the Economic Research Service and the National Institute of Food and Agriculture.

Drug pricing legislation may not affect a new $2.1 million gene therapy drug
The blockbuster drug Zolgensma, which treats spinal muscular atrophy, is now the most expensive drug in the world

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. The agency approved a $2.1 million Novartis therapy for spinal muscular atrophy Friday, making it the world’s most expensive drug. (Al Drago/CQ Roll Call file photo)

The recent approval of a treatment poised to become the world’s most expensive drug comes as Congress debates measures meant to address high prices — yet so far what lawmakers are attempting might not impact cases like this $2.1 million therapy.

The FDA announced Friday it was approving Novartis AG’s gene therapy Zolgensma, a one-time treatment designed to help young children with spinal muscular atrophy. The agency’s announcement said the safety and effectiveness of the drug was based on clinical trials that yielded positive results for patients with the rare disease.

Alexander, Murray outline plan to lower health costs
Alexander he hopes it will get a committee mark up next month and the Senate will debate a bill in July

Chairman Lamar Alexander, R-Tenn., and ranking member Sen. Patty Murray, D-Wash., conduct a Senate Health, Education, Labor and Pensions Committee hearing in Dirksen Building titled "Vaccines Save Lives: What Is Driving Preventable Disease Outbreaks?" on March 5, 2019. (Tom Williams/CQ Roll Call file photo)

Two influential senators released draft health care legislation Thursday, a package of narrowly tailored proposals that will likely be part of a measure to lower health care costs that lawmakers hope to pass this year.

The draft bill, from Health, Education, Labor and Pensions Chairman Lamar Alexander, R-Tenn., and ranking member Patty Murray, D-Wash., targets five areas: banning surprise medical bills; speeding low-cost generic drugs to market; increasing transparency; improving public health; and enhancing health information technology, according to a summary.