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Clinton FDA chief to lead review of agency food, tobacco programs

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— Clinton-era FDA commissioner Jane Henney to lead Reagan-Udall review of FDA’s food safety and tobacco programs.

— HHS Secretary Xavier Becerra declares monkeypox a public health emergency.

— Senate Democrats’ drug pricing proposal could receive a ruling from the chamber’s parliamentarian as soon as Friday ahead of weekend debate.

It’s Friday. Welcome to Prescription Pulse. This court case has us reading up on the biological weapons statute.

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JANE HENNEY TO LEAD EXTERNAL REVIEW OF FDA’s FOOD, TOBACCO OFFICES — The Reagan-Udall Foundation has picked Clinton-era FDA commissioner Jane Henney to spearhead its 60-day review of operations in the agency’s food safety and tobacco divisions, Katherine and POLITICO’s Adam Cancryn scoop. Henney, the first woman to lead the agency, has not formally been announced yet.

MONKEYPOX DECLARED A PUBLIC HEALTH EMERGENCY — The Biden administration on Thursday declared monkeypox a public health emergency, a move that aims to accelerate vaccine distribution and testing, David, Adam and POLITICO’s Erin Banco and Betsy Woodruff Swan report. Administration officials began holding the first of weekly monkeypox briefings with congressional staff on Thursday, according to three Hill aides.

FDA Commissioner Robert Califf said the government is considering deployment of a strategy called “dose sparing” to stretch supply of the Jynneos vaccine as the U.S. hits a “critical inflection point” that warrants taking additional steps to address the rise in monkeypox infections. That approach would allow health care providers to use a one-dose vial of the vaccine to administer up to five separate doses.

The agency plans to decide in the “next few days” whether to move forward with that plan, which would require a separate emergency declaration under section 564 of the Federal Food, Drug and Cosmetic Act, according to Califf.

FDA LAYS OUT PLAN FOR MONKEYPOX LAB-DEVELOPED TESTS — The FDA plans to allow monkeypox laboratory-developed tests to stay on the market if the additional emergency declaration that impacts the agency is issued while labs pursue required emergency use authorizations, an agency official told POLITICO.

“What we’re looking at is having in place a notification policy, similar to what we’ve put in place in late February of 2020,” an FDA official, granted anonymity to discuss the agency’s plans, said. “So anyone who had made a test and they validated it could go ahead and use it, or they already are using the test, they can go ahead and notify us and then send us their validation data at a later point.”

EPA ETHYLENE OXIDE AWARENESS PUSH WORRIES DEVICE MAKERS — Twenty-three U.S. communities near sterilizing facilities face cancer risks dramatically higher than the EPA’s maximum acceptable threshold, according to new information released by the agency Wednesday, raising major concerns in the medical device industry and at the FDA, POLITICO’s Annie Snider and David report.

“We are equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations,” top FDA medical device regulator Jeff Shuren said in a statement. “The FDA shares concerns about the release of ethylene oxide at unsafe levels into the environment.”

SENATE DEMS TO HOLD WEEKEND SESSION ON RECONCILIATION — Senate Democrats plan to proceed to a vote on their massive reconciliation measure on Saturday, Majority Leader Chuck Schumer announced Thursday. That timeline reflects continued haggling between Democrats and Republicans — with final say by the chamber’s parliamentarian — about what can and cannot be included in the bill, POLITICO’s Burgess Everett and Marianne Levine report.

Late Thursday, Arizona Democrat Kyrsten Sinema said she would sign on to the bill, which aims to advance key parts of the Democrats’ domestic agenda ahead of the midterm elections, after changes are made to it. “We have agreed to remove the carried interest tax provision, protect advanced manufacturing and boost our clean energy economy in the Senate’s budget reconciliation legislation,” Ms. Sinema said in a statement.

Drug pricing’s status: A ruling on the measure’s prescription drug provisions could come as soon as Friday. Besides permitting Medicare to negotiate the price of certain drugs, the legislation would also include a provision to reduce the cost of insulin, though that’s expected to be challenged by Republicans.

Congressional Budget Office Director Phillip Swagel confirmed on Thursday to Rep. Jason Smith (R-Mo.), the House Budget Committee’s ranking member, that it projects the Senate bill’s inflation rebate and negotiation provisions would spur an increase in launch prices for new drugs — a prospect Prescription Pulse pointed out a few weeks ago. CBO predicts higher launch prices would primarily affect spending on drugs under Medicaid and Medicare Part B.

“Over time, slower price growth would attenuate the effect of higher launch prices,” Swagel wrote in the letter.

PhRMA AMPS UP ADVOCACY AS VOTE NEARS — The head of the major pharmaceutical industry trade group is making his last pitch to Congress as the Senate nears votes on the sweeping reconciliation package — and threatening quick retaliation if lawmakers vote to back it, POLITICO’s Megan Wilson reports. The Pharmaceutical Research and Manufacturers of America and its 31 board members sent a letter to every lawmaker on Thursday, urging them to oppose the package.

“Those members who vote for this bill will not get a free pass,” said PhRMA CEO Steve Ubl. “We’ll do whatever we can to hold them accountable.”

SENATE DEMS SEND MEDICATION ABORTION RECS TO HHS — Three Senate Democrats sent a list of recommendations on Wednesday to HHS Secretary Xavier Becerra ahead of the department’s Sunday deadline to report to the Biden administration on ways it will ensure access to medication abortion in the wake of the Supreme Court’s Dobbs decision.

Sens. Elizabeth Warren (D-Mass.), Mazie Hirono (D-Hawaii) and Tammy Baldwin (D-Wis.) urged DOJ and HHS to intervene in — or launch their own — lawsuits against states with total medication abortion bans. They also suggested that the FDA quickly finalize changes to the Risk Evaluation and Mitigation Strategies for mifepristone and consider adding an indication for miscarriage to the mifepristone with misoprostol label to ensure those experiencing pregnancy loss in states with medication abortion restrictions have access to those drugs.

FDA TO EVALUATE MORE THAN 350 SYNTHETIC NICOTINE PRODUCTS — In an update on Wednesday, the FDA said the agency would continue to evaluate marketing applications for more than 350 synthetic nicotine products after rejecting applications for more than 88,000 products without sufficient information, Katherine reports.

Technically, after July 13 all unauthorized products containing synthetic nicotine became illegal. It’s unclear whether the agency will remove products with synthetic nicotine — which are mostly vapes — from shelves while it evaluates their applications. Brian King, director of the Center for Tobacco Products, said that synthetic nicotine vapes “may” be subject to enforcement. For tobacco vapes, the agency used its enforcement discretion, which allowed products to remain on shelves amid FDA review.

PUBLIC COMMENT ON MENTHOL CIGS, FLAVORED CIGARS RULES CONCLUDES — Tuesday was the deadline for the public to submit comments to the FDA on its proposed rules banning menthol cigarettes and flavored cigars.

Eyes emoji: “We support a science and evidence-based approach to reduce the use of combustible tobacco products, including menthol cigarettes, as part of a comprehensive framework to advance tobacco harm reduction. … We believe it is critical to have a marketplace of viable, scientifically substantiated, less harmful alternatives to move adult smokers (who have not or will not quit) down the continuum of risk,” Parker Kasmer, Juul’s senior vice president of regulatory affairs, said.

EXPERTS SAY AIDS, MALARIA, TB IN DANGER OF REVERSING AMID COVID — Health leaders in many low-income countries are increasingly questioning Western donors who want them to put Covid-19 at the top of their priority lists, arguing that the donors’ money would be better spent on a holistic approach to disease, POLITICO’s Daniel Payne reports.

To some in developing countries, the existing epidemics are turning out to be a bigger problem than Covid-19 is. “Unfortunately, if you look at the number of people infected with tuberculosis, it’s a big number compared to Covid,” said Choub Sok Chamreun, who works on HIV, malaria and TB responses — as well as building community health care — in Cambodia.

Eli Lilly will begin selling its Covid monoclonal antibody commercially to states and hospitals this month as the federal government exhausts its own treatment supply, The Wall Street Journal reports.

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

The American Clinical Laboratory Association sent a letter to CMS Administrator Chiquita Brooks-LaSure last week, requesting that the agency communicate that monkeypox testing should be covered by Medicare, state Medicaid programs and commercial insurers.

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( Information from politico.com was used in this report. To Read More, click here )

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