WASHINGTON — As the federal budget impasse ends its third week, Democrats in Congress and President Trump appear no closer to a compromise, health clinics serving Native Americans in two cities say they’re closing their doors, and the FDA is calling back furloughed workers to inspect high-risk food.
Native American Clinics Face Imminent Closure with Gov’t Shutdown
Some medical clinics serving Native Americans ran out of funding this week thanks to the federal government’s partial shutdown, and closures were expected by week’s end.
“Friday is going to be our last day until the government reopens or another source of funding becomes available,” said Kerry Hawk Lessard, executive director of Native American Lifelines, which operates clinics in Boston and Baltimore under contract with the federal Indian Health Service (IHS), earlier this week.
“Lives are definitely at risk because of the shutdown,” Mary Smith, JD, former IHS acting director and a member of the Cherokee Nation, told MedPage Today.
The IHS provides direct services, run by the federal government, and also funds tribally run services. Under the shutdown, the direct services continue, although employees are not being paid. Funding to the tribes and to urban contractors such as Native American Lifelines, however, has stopped.
Food Inspections Get Spottier
As the federal government shutdown continues, consumer representatives worry that food products routinely inspected by the FDA or the Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) are making their way to Americans’ kitchen tables.
“So, if there’s a peanut paste plant that’s infested with rodents and is creating foodborne illness risks for consumers, the FDA is not going to be coming out to that plant while the shutdown is going on,” he said.
House, Senate Members Announce Drug Pricing Bills
Congressional Democrats and progressives continued their push Thursday to pass legislation aimed at lowering the cost of prescription drugs as they announced the introduction of three separate bills on the issue.
“The people in our country pay by far the highest prices in the world for the prescription drugs they need,” said Sen. Bernie Sanders (I-Vt.) at a Thursday morning press conference at the Capitol. “That has got to end; the legislation we’re supporting will do just that. It’s totally absurd that one in five people who get a prescription from their doctor are unable to fill that prescription because they can’t afford the price of the medicine.”
The bills announced by the group of mostly Democratic senators and representatives included: a bill to allow Medicare to negotiate drug prices for beneficiaries; a bill to require that the price of a drug not be higher than the median price of the same drug in five economically similar industrialized countries; and a bill to allow U.S. citizens and residents to import lower-cost drugs from Canada for their personal use.
“President Trump over and over has talked about the high cost of prescription drugs,” Sanders said. “He said he was going to stop pharmaceutical companies from getting away with murder. [Mr. President], if you’re serious about lowering prescription drug costs in this country, support our legislation and get your colleagues on board.”
Make Uloric Second-Line for Gout, FDA Advisors Say
FDA advisors overwhelmingly voted that the benefits of urate-lowering febuxostat (Uloric) outweigh its risks for selected gout patients, though most advocated broad unrestricted access only as a second-line therapy.
Members voted 19 to 2 (with one abstention) that a patient population exists for whom febuxostat’s benefit-to-risk profile is favorable in its current indication as first-line treatment for hyperuricemia in gout, despite a known link to cardiac deaths.
This includes individuals who have had a serious skin reaction to or otherwise “absolutely don’t tolerate” allopurinol, the mainstay xanthine oxidase inhibitor for uric acid reduction, suggested Steven Nissen, MD, of the Cleveland Clinic and a panelist at the meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
“For everybody else, for the general population with gout, I would say that in those people the benefits do not outweigh the risk,” he cautioned.
Fellow panelists largely agreed with that sentiment, given that febuxostat isn’t proven to be more effective than allopurinol and was in fact linked to a higher risk of cardiovascular mortality in the CARES trial.
On Wednesday the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee will discuss romosozumab injection, for potentially treating osteoporosis in postmenopausal women at high risk for fracture.
On Thursday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will weigh the risks and benefits of sotagliflozin oral tablet, for potentially treating adults with type 1 diabetes mellitus.