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Health Care |
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FDA drafts new guidance to treat substance use disorders |
There aren't any FDA-approved medications for cocaine, methamphetamine and prescription stimulants. The agency is looking to fill that void. |
An agency draft guidance lays out recommendations on the development of clinical trials for drugs aimed at treating moderate to severe cocaine use disorder, methamphetamine use disorder or prescription stimulant use disorder. "When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps," said Marta Sokolowska, deputy center director for Substance Use and Behavioral Health under the Food and Drug Administration (FDA). Some of the recommendations: - Study people with different substance abuse disorders separately.
- Clinical trials should be randomized, double-blind and placebo-controlled.
- Progress shouldn't solely be measured with urine toxicology testing, with the agency saying it doesn't account for "how the subject feels, functions, or survives."
Abuse of opioids, which are depressants, can be treated medically through approved drugs like buprenorphine, methadone and naltrexone. With no analogous options available for stimulant use disorder, most treatments tend to be therapy-based. Some medications may be given to patients with stimulant use disorder, but those would be considered off-label use. Overdose deaths involving stimulant substances have been on the rise. From 2012 through 2019, the rate of cocaine-involved overdose deaths more than tripled, according to the National Center for Health Statistics. In 2021, cocaine was involved in almost 23 percent of overdose deaths while fatal overdoses related to other stimulants like ecstasy, methamphetamine and prescribed medications jumped by 37 percent from the previous year. The FDA will be accepting public comments on this guidance until Dec. 4. |
Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health. |
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How policy will be impacting the health care sector this week and beyond: |
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The Centers for Disease Control and Prevention (CDC) are no longer printing the COVID vaccination cards that became a trademark of the pandemic, according to its website. "CDC no longer distributes the white CDC COVID-19 Vaccination cards and does not maintain vaccination records," the CDC website states on its Frequently Asked Questions page under a banner reading "After Your Vaccine." The CDC further instructs … |
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| A majority of members on a federal panel tasked with providing U.S. dietary guidance have ties to industries with a stake in those decisions, according to a new watchdog report. Nine out of the 20 experts on the 2025 Dietary Guidelines Advisory Committee (DGAC) had financial or other ties over the past five years to food, pharmaceutical, grocery and other industries, according to new findings from the nonprofit U.S. Right to Know. |
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Former White House aide Cassidy Hutchinson said Wednesday that former President Trump is afraid of being poisoned. "He does have a very potent fear of being poisoned," Hutchinson told comedian Jimmy Kimmel on his late night show.
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Branch out with a different read from The Hill: |
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Zimbabwe announces 100 suspected cholera deaths and imposes restrictions on gatherings |
HARARE, Zimbabwe (AP) — Zimbabwe has recorded 100 suspected deaths from cholera and more than 5,000 possible cases since late last month, prompting the government to impose restrictions to stop the spread of the disease, including limiting numbers at funerals and stopping some social gatherings in affected areas. The health ministry announced … |
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Local and state headlines on health care: | - Legal opinion on opioid funds limits Idaho more than other states, health officials say (Idaho Capital Sun)
- State launches new respiratory illness dashboard to track COVID-19, flu, and RSV (Boston Globe)
- Hawaii gets federal funding boost in mental health support for Maui fire victims (Honolulu Civil Beat)
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Health news we've flagged from other outlets: | - Surgery and other medical procedures are delayed by the Kaiser strike, patients say (NBC News)
- Social Security chief orders broad review of benefit overpayments (KFF Health News)
- US FDA panel says Amgen lung cancer drug data cannot be relied on (Reuters)
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Most read stories on The Hill right now: |
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House Republicans are aiming their fire at Rep. Matt Gaetz (R-Fla.) after the congressman staged a successful effort to oust Rep. Kevin McCarthy (R-Calif.) … Read more |
| Former President Trump’s New York fraud trial wrapped up its fourth day Thursday. The day began with the continued cross-examination of a former … Read more |
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Opinions related to health submitted to The Hill: | |
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You're all caught up. See you tomorrow! |
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