FDA

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.

McConnell introduces bill making the legal smoking age 21
“Youth vaping is a public health crisis,” Kentucky Republican says

Senate Majority Leader Mitch McConnell, R-Ky., introduced legislation Monday that would raise the minimum age to buy tobacco to 21. (Tom Williams/CQ Roll Call)

Senate Majority Leader Mitch McConnell on Monday introduced a bill to raise the federal age for purchasing tobacco products, including e-cigarettes, to 21, increasing the chances that Congress will clear a significant smoking-related bill for the first time since a major tobacco control law was enacted a decade ago.

The bill comes amid growing concerns about the youth use of e-cigarettes, which reached record levels in 2018. That marked a troubling reversal of declines in smoking traditional cigarettes.

House health care bill puts generic drug industry in bind
Low-cost generic drug makers expected a floor vote on a signature bill, but the law is being packaged with two measures industry opposes

Rep. Buddy Carter, R-Ga., attends a House Energy and Commerce Environment Subcommittee hearing in Rayburn Building. Carter is a sponsor of a bill that would make it harder to stretch out a six-month exclusivity period awarded to the first generic version of a brand-name drug. Generic drug pricing bills will be taken up by the House Thursday. (Tom Williams/CQ Roll Call file photo)

This was supposed to be a good week for the makers of low-cost generic drugs, as a bill that is one of their top priorities gets a House floor vote. Instead, the industry finds itself clouded by allegations of price fixing, and its signature bill is being packaged with two measures they oppose.

The bill that the House will take up Thursday combines three drug pricing measures with bills to strengthen the individual health insurance market.

FDA grapples with AI medical devices
New approach to artificial intelligence extends the agency’s controversial fast-track process

The FDA has already approved “locked” artificial intelligence-based devices, such as one that analyzes images of a patient’s retina for signs of diabetic retinopathy. Now the agency is weighing how to certify devices that learn and evolve. (iStock)

Imagine a not-too-distant future when medical devices powered by artificial intelligence continuously adapt to new symptoms presented by patients and learn how to make accurate diagnoses much like a well-trained physician would.

The Food and Drug Administration is preparing for such a future and weighing how to assess and certify such medical devices, seeing them more like living things that can’t be regulated in the same manner as old-fashioned equipment.

Trump administration swayed by conservative think tank on abortion, LGBT decisions, group says
Ties between administration and The Heritage Foundation correlate with several health policy decisions, liberal watchdog group says

HHS Office of Civil Rights Director Roger Severino speaks at a news conference at the Department of Health and Human Services on January 18, 2018 in Washington, DC. Severino, a former director of The Heritage Foundation’s DeVos Center for Religion and Civil Society, joined HHS as the director of OCR in late March 2017. Close ties between the administration foundation correlate with several Trump administration health policy decisions, a liberal think tank says. (Aaron P. Bernstein/Getty Images)

Close ties between the administration and a prominent conservative think tank correlate with several Trump administration health policy decisions, according to new information from a liberal government watchdog group shared exclusively with CQ Roll Call.

The 35-page Equity Forward report says that The Heritage Foundation’s influence plays a large role in decisions related to abortion, fetal tissue research, contraception and protections for same-sex couples.