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Clinton-era FDA Commissioner Jane Henney will lead the Reagan-Udall review of the FDA’s Food Safety and Tobacco Programs.

HHS Secretary Xavier Becerra has declared monkeypox a public health emergency.

Senate Democrats’ drug pricing proposal could get a ruling from lawmakers as early as Friday, ahead of weekend debates.

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Send your tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Catherine Ellen Foley ([email protected] Or @katherineefoley).

Message from UnitedHealth Group:

Beginning in 2023, we have eliminated copays for eligible UnitedHealthcare members on five critical medicines, including insulin and epinephrine. See how we’re making prescription drugs more affordable for the patients who rely on them most.

Former FDA Commissioner Jane Henney will lead a review of the FDA’s Food Safety and Tobacco Division operations. | | Sarah Silbiger/Getty Images

Jane Heney will lead an external review of the FDA’s Office of Food and Tobacco.

Monkeypox declares public health emergency The Biden administration on Thursday declared monkeypox a public health emergency, a move aimed at accelerating vaccine distribution and testing, says David Adams. , and reported by Politico’s Erin Banco and Betsy Woodruff-Swan. Administration officials began holding the first weekly monkeypox briefing with congressional staff on Thursday, according to three Hill aides.

FDA Commissioner Robert Calif said the government has reached a critical inflection point that justifies taking additional steps to combat the rise in monkeypox infections, so the government has decided to increase the supply of the Jynneos vaccine. said it is considering deploying a strategy called dose sparing. This approach would allow providers to use a single vial of the vaccine to deliver up to five separate doses. increase.

The California State Department will decide in the coming days whether to proceed with plans that require another emergency declaration under Section 564 of the Federal Food, Drug, and Cosmetic Act.

FDA develops plans for tests developed by Monkeypox Institute Officials told POLITICO that they plan to allow tests developed by the Monkeypox Institute to continue to be marketed.

The agency was considering implementing a notification policy similar to the one it introduced in late February 2020, said an FDA official who had been granted anonymity to discuss the agency’s plans. So anyone who writes and validates the test can use it. Alternatively, if you’re already using testing, you can go ahead and let us know and send us your validation data later.

EPA Ethylene Oxide Awareness Raises Device Maker Concerns, Report POLITICO’s Annie Snyder and David.

Jeff Shuren, the FDA’s head of medical device regulators, said in a statement that he was equally concerned about the potential impact of shortages of sterilized medical devices due to disruptions in the operations of commercial sterilization facilities. The FDA shares concern about unsafe levels of ethylene oxide being released into the environment.

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Senator Kristen Sinema said she would sign the party’s climate, tax and health bills. Senate Majority Leader Chuck Schumer is scheduled to vote on Saturday. | | Wynn McNamee/Getty Images

Senate Democrats to Hold Weekend Session on Reconciliation Senate Democrats plan to move on to a massive reconciliation bill vote on Saturday, Majority Leader Chuck Schumer announced Thursday. The timeline reflects ongoing negotiations between Democrats and Republicans to make final decisions by House representatives on what can and cannot be included in the bill, said POLITICO’s Burgess Everett and Marianne Levine. has reported.

Late Thursday, Kirsten Cinema of the Arizona Democratic Party said it would sign legislation aimed at advancing a key piece of the Democratic Party’s domestic agenda ahead of the midterm elections after the changes were made. In a statement, Cinema said the Senate Budget Adjustment Act agreed to remove provisions for interest tax carryforwards, protect advanced manufacturing and promote a clean energy economy.

Drug Pricing Status: A ruling on action on prescription drug regulations could come out as early as Friday. In addition to allowing Medicare to negotiate the price of certain drugs, the bill would also include provisions to cut the cost of insulin, which is expected to be challenged by Republicans.

Congressional Budget Office Secretary Philip Swagel on Thursday told Rep. Jason Smith (R-Mo), a leading member of the House Budget Committee, that the Senate bill’s inflation rebates and bargaining clause will spur higher launch prices for new drugs. I confirmed that it was predicted. Outlook Prescription Pulse pointed out a few weeks ago. The CBO expects higher launch prices will primarily affect spending on Medicaid and Medicare Part B drugs.

Over time, a slowdown in price growth would lessen the impact of higher launch prices, Swagel wrote in the letter.

PhRMA ramps up advocacy as vote nears Head of major pharmaceutical industry trade group makes final pitch to Congress as Senate nears vote on broad settlement package, lawmakers back it The US Research and Manufacturers of Drugs and its 31 board members sent a letter to all lawmakers on Thursday urging them to vote against the package.

PhRMA CEO Steve Ubl said members who voted for the bill would not get free passes. Do everything you can to hold them accountable.

Senate Democrats Send HHS Recommendations on Medical Abortion Three Senate Democrats sent HHS Secretary Xavier Becerra Wednesday a list of recommendations to report to the Biden administration ahead of Sunday’s deadline, and the courts Dobbs judgment.

Senators Elizabeth Warren (D-Massachusetts), Mazzy Hirono (D-Hawaii) and Tammy Baldwin (D-Wisconsin) urged DOJ and HHS against states to outright ban medical abortion. We asked them to intervene or bring their own lawsuits. They also recommend that the FDA urgently finalize changes to mifepristone’s risk assessment and mitigation strategy, consider labeling mifepristone as misoprostol and add miscarriage indications, and consider medical abortion. proposed to ensure that people experiencing miscarriages in states with restricted access to these drugs.

FDA to evaluate more than 350 synthetic nicotine products In an update Wednesday, the FDA continues to evaluate marketing applications for more than 350 synthetic nicotine products after rejecting more than 88,000 product submissions without sufficient information. Katherine reports that she said she would.

Technically, after July 13th, all unauthorized products containing synthetic nicotine are illegal. It’s unclear if the agency will remove products containing synthetic nicotine, which are primarily e-cigarettes, from its shelves while it evaluates their uses. Ark said it could be subject to enforcement.

Public Comments on Menthol Cigars, Flavored Cigars Rule Conclusions Tuesday was the deadline for the public to submit comments to the FDA on the proposed rule banning menthol cigarettes and flavored cigars.

Eye emoji: We support scientific and evidence-based approaches to reduce the use of combustible tobacco products, including menthol cigarettes, as part of our comprehensive framework to advance tobacco harm reduction. increase. Parker Kasmer, senior vice president of regulatory affairs at Juuls, advocates a viable, scientifically proven, harmless approach to de-risking adult smokers (who have not quit or plan to quit). We believe it is important to have a market for fewer alternatives.

Message from UnitedHealth Group:

Beginning in 2023, eligible UnitedHealthcare members will receive $0 co-payments for five critical medicines (insulin for diabetes, epinephrine for allergic reactions, glucagon for hypoglycemia, naloxone for opioid overdose, and albuterol for acute asthma attacks) will be

This is an important step to drive patient affordability and combat the high price prescriptions set and raised by drug manufacturers. We are committed to continuing to use our capabilities to reduce out-of-pocket costs for consumers. Learn more.

Experts say AIDS, malaria and tuberculosis are at risk of reversal amid COVID POLITICO’s Daniel Payne reports that a holistic approach to the disease has been spent.

The existing epidemic is proving to be a bigger problem than Covid-19 for some people in developing countries. That’s a lot, said Choub Sok Chamreun, who works on HIV, malaria and tuberculosis response and building community health care in Cambodia.

Eli Lilly plans to begin commercially selling Covid monoclonal antibodies to states and hospitals this month as the federal government has exhausted its supply of its own treatment, reports The Wall Street Journal.

The Health Industry Distributors Association and 23 other health care groups sent letters to congressional leaders on Thursday urging passage of the PREVENT Pandemic Act.

The American Association of Clinical Laboratories last week sent a letter to CMS administrator Chiquita Brooks-LaSure requesting that agencies be told that monkeypox testing should be covered by Medicare, state Medicaid programs, and private insurance companies. did.

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