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Health Care |
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Popular decongestant doesn't do much, FDA panel concludes |
A Food and Drug Administration (FDA) advisory committee voted unanimously this week that a common nasal decongestant sold in products made by brands like Sudafed and Benadryl is not effective.
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The 16 voting members of the Nonprescription Drugs Advisory Committee (NDAC) all voted "no" on the question of whether current scientific data support the use of oral phenylephrine as a nasal decongestant. Phenylephrine can be found in over-the-counter products like Sudafed PE Maximum Strength Congestion & Sinus Pressure Relief Tablets, Benadryl Allergy Plus Congestion Ultratabs as well in combination with other active ingredients like in Vicks NyQuil Severe Cold & Flu Relief Liquid.
It is among the most popular decongestants, but evidence presented over the course of the two-day meeting showed that while phenylephrine appeared to be safe as a medication, it demonstrated no effect on nasal congestion.
In a 2015 study presented on Monday, no statistically significant difference was found between study participants who received phenylephrine and a placebo and no meaningful difference was observed between different doses of the drug.
While committee members expressed concerns over allowing a product with dubious effectiveness to remain on the market, the vote on Tuesday will not immediately impact the availability of medications containing phenylephrine.
Most medications are withdrawn from the market in the U.S. due to a request from the manufacturer or the FDA's request out of concern for public health.
The Consumer Healthcare Products Association (CHPA) — a trade group which represents the makers of over-the-counter (OTC) drugs, dietary supplements and consumer medical devices — said it was "disappointed" by the committee's vote.
"We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE's regulatory status," CHPA President and CEO Scott Melville said in a statement. |
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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Florida Gov. Ron DeSantis (R) and the state’s surgeon general are advising against the use of updated COVID-19 vaccines for anyone under the age of 65, a move that counters a new recommendation from the Centers for Disease Control and Prevention (CDC). Speaking Wednesday on a panel with other physicians who have cast doubt on the COVID vaccine — including some who lobbied Trump administration officials to back the “herd … |
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| For the first time since the onset of the COVID-19 pandemic, the federal government will not be able to ensure the shots for this fall’s vaccination campaign will be available to the public for free. When the public health emergency ended in May, so too did the administration’s ability to purchase and distribute shots, tests and treatments for all Americans. The COVID vaccine is now commercialized, just like the … |
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Senate Republicans are pressuring Senate Majority Leader Chuck Schumer (D-N.Y.) to vote on some of President Biden’s top military nominations amid Sen. Tommy Tuberville’s (R-Ala.) hold, which is blocking Senate leadership from moving nominations and promotions in expedited package votes. GOP senators pushed for targeted voting during a Senate Armed Services Committee hearing Tuesday to appoint Gen. David Allvin … |
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Upcoming news themes and events we're watching: | - The Energy and Commerce health subcommittee will hold a hearing Thursday on drug shortage legislation.
- The Select Subcommittee on the Coronavirus Pandemic holds a hearing Thursday on the "erosion of the doctor-patient relationship."
- The Southern District Court of Ohio will hear oral arguments on Friday in a lawsuit from the U.S. Chamber of Commerce over the administration's Medicare drug price negotiation program.
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Public health preparedness is how we protect American lives. |
From new viruses to the risk of chemical or biological attacks, public health threats can emerge anywhere. At any time. Now is the time to protect us all against things we hope never happen — just in case they ever do. Learn more. |
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Branch out with a different read from The Hill: |
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There's no sign of widespread COVID-19 mandates in the US. Republicans are warning of them anyway |
NEW YORK (AP) — As Americans fend off a late summer COVID-19 spike and prepare for a fresh vaccine rollout, Republicans are raising familiar fears that government-issued lockdowns and mask mandates are next. It’s been a favorite topic among some of the GOP’s top presidential contenders. Florida Gov. Ron DeSantis told reporters … | |
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Local and state headlines on health care: | - Despite successes, addiction treatment programs for families struggle to stay open (KFF Health News)
- As COVID numbers rise, Hochul urges New Yorkers to get the new vaccine (WXXI)
- Copay requirements paused for noncitizens on state health plan (Capitol News Illinois)
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Health news we've flagged from other outlets: | - What to make of Biden's latest Cancer Moonshot efforts (Stat)
- Overdose deaths continue to rise in the US, reaching another record level, provisional data shows (CNN)
- Covid is here to stay. How will we know when it stops being special? (The Washington Post)
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Public health preparedness is how we protect American lives. |
From new viruses to the risk of chemical or biological attacks, public health threats can emerge anywhere. At any time. Now is the time to protect us all against things we hope never happen — just in case they ever do. Learn more. |
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Most read stories on The Hill right now: |
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New video surfaced Wednesday showing Rep. Lauren Boebert (R-Colo.) being escorted out of a performance of the musical "Beetlejuice" on Sunday night. … Read more |
| Then-Senate Majority Leader Mitch McConnell (R-Ky.) didn't respond to warnings from Sen. Mitt Romney (R-Utah) about the Jan. 6 insurrection in the … Read more |
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Opinions related to health submitted to The Hill: | |
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