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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim , Lauren Gardner and Katherine Ellen Foley | | | | BURR, MURRAY PRESS FORWARD ON LEFTOVER FDA BILLS — FDA legislation that fell off the September user fee reauthorization package is likely to find a home in an end-of-year government funding bill after Democrats emerged stronger than expected from the midterm election. “On nerd FDA policy, this is setting up a situation where even with the Senate not known, with a slim margin in the House, this does set us up to have a Christmas tree situation,” said a former HELP Committee aide. Reps. Frank Pallone (D-N.J.) and Cathy McMorris Rodgers (R-Wash.) and Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.) have pledged to return to the negotiating table ahead of the Dec. 16 government funding deadline to hash out the policies left behind, such as provisions to tweak FDA’s accelerated approval pathway and bolster clinical trial diversity. “Hope springs eternal and we are waiting to see what we can do with our colleagues on this,” a Burr spokesperson told POLITICO. A Murray aide said the senator "continues to work with Sen. Burr and her House counterparts on strong, bipartisan legislation to include in a robust end of year package."
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Sens. Patty Murray and Richard Burr, pictured, and Reps. Frank Pallone and Cathy McMorris Rodgers have pledged to work to add FDA policies to a year-end package. | Cliff Owen/AP Photo | ALL EYES ON ARIZONA, NEVADA SENATE RACES — With the Georgia Senate race headed to a Dec. 6 runoff and votes still being tallied in Arizona and Nevada, control of the chamber hangs in the balance. Which party holds the House majority is also still up in the air, though Republicans are expected to eke out a narrow edge over Democrats. The health panel most likely to see a leadership shakeup is Senate HELP. Murray is expected to become the top Democrat on the Appropriations Committee, setting up Bernie Sanders (I-Vt.) to take the HELP helm. The big question mark: Will Sen. Rand Paul take the place of Burr, who’s retiring next month, on the GOP side of the dais? Or will he seek to lead Republicans on the Homeland Security and Governmental Affairs Committee, where he also could wield oversight and subpoena power over a wider range of Biden administration officials. The Kentucky Republican told David in September he’d decide his next move after the election; whether the GOP controls the chamber likely plays into his calculus. Sen. Bill Cassidy (R-La.) is in the mix to take the top Republican slot on the HELP Committee if Paul pursues being the top HSGAC Republican. The House: Should Republicans retake the majority, Rep. Cathy McMorris Rodgers (R-Wash.) is expected to take the Energy and Commerce gavel. New Jersey Rep. Frank Pallone is likely to remain the panel’s top Democrat. It’s Friday. Welcome to Prescription Pulse. All eyes are on Twitter after fake verified accounts popped up this week . Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , Ben Leonard talks with Alice Miranda Ollstein about his conversation with Cassidy, who is a telehealth proponent and has repeatedly warned about hackers targeting hospitals and other health care organizations. Plus, Lauren Gardner takes Pulse Check's 60 second challenge.
| | | | | | | TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO’s must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING . | | | | | | | | BREATHING TUBE SHORTAGE THREATENS PEDIATRIC PATIENTS — Shortages of specialty tracheostomy tubes used to help children breathe after surgery could threaten the ability of health care providers to care for children as they recover from serious illnesses, your host reports. “In the hospital setting, you have children who may be staying on a ventilator longer than otherwise because they can’t be switched onto the tracheostomy tube due to insufficient supply,” Jeff Shuren, the FDA’s top medical device regulator, said in an interview. FDA WARNS OF ANIMAL SEDATIVE IN SOME ILLICIT DRUGS — The FDA on Tuesday told health care providers to be aware that xylazine — an FDA-approved drug for animals that works as a sedative and pain reliever — may be involved in fentanyl, heroin and other illicit drug overdoses. “Xylazine is not safe for use in humans and may result in serious and life-threatening side effects that appear to be similar to those commonly associated with opioid use, making it difficult to distinguish opioid overdoses from xylazine exposure,” the FDA alert states . “However, we do not know if side effects from xylazine exposure can be reversed by naloxone.”
| | | MORE THAN 3M MINORS USED TOBACCO IN 2022, FEDERAL SURVEY FINDS — More than 3 million middle and high school students have used a tobacco product in the past month, according to the National Youth Tobacco Survey, Katherine reports. E-cigarettes were the most popular product for middle and high school students, with nearly 2.6 million regular users. Roughly half a million students reported using cigars, and 440,000 students reported smoking cigarettes. The CDC and FDA, which co-author the report annually, stated that because of the differences in methodology due to the pandemic, this year’s NYTS can’t be compared to the 2021 survey. In 2021, 2.55 million students reported using tobacco products in the past 30 days , including more than 2 million who reported vaping regularly and 410,000 who smoked cigarettes at least once in the prior month. COMPANIES SEEK INJUNCTION AGAINST CALIF. OVER FLAVORED TOBACCO BAN — R.J. Reynolds, the makers of Newport menthol cigarettes, and several other tobacco manufacturers have filed a complaint against the state and requested a preliminary injunction, calling its ban on flavored tobacco products unconstitutional, Katherine reports. The tobacco plaintiffs argue that California cannot legally implement a ban on flavored tobacco products, because it would be effectively creating a new product standard — something that only the FDA can do. The suit is in response to a ballot measure on Tuesday’s midterm elections. Californians voted to uphold a 2020 state law banning the sale of most flavored tobacco products, with the exception of loose leaf and hookah tobacco, and premium cigars. The law had been set to go into effect in January 2021. The newly passed ban is set to be effective by Dec. 22 at the latest. The California Attorney General’s office derided the complaint as an industry tactic.
| | | NEW TREATMENT FOR HOSPITALIZED ADULTS WITH COVID-19 — The FDA on Wednesday granted emergency use authorization to Kineret for the treatment of severe Covid-19 in some adults, Katherine reports. In an authorization letter sent to the drug's manufacturer , Swedish Orphan Biovitrum AB, also known as Sobi, the agency said the injection could be used to treat adults receiving supplemental oxygen, have other markers of elevated immune activity and are at risk of declining. PUBLIC HEALTH EMERGENCY WATCH — There is no expectation that the Biden administration will issue a 60-day notice before Saturday that the Covid-19 public health emergency will end, a senior administration official told POLITICO’s Adam Cancryn.
| | | An investigation by POLITICO Europe and the Bureau of Investigative Journalism describes how the pharmaceutical industry stymied a proposal to waive some intellectual property rights for Covid-19 treatments during the pandemic. AstraZeneca no longer plans to apply for FDA approval of its Covid-19 vaccine amid low U.S. demand for primary series shots, The Wall Street Journal reports. Two of Juul’s early investors are providing the company enough funds to avoid filing for bankruptcy , Jennifer Maloney reports for The Wall Street Journal. The company is also laying off 400 people, or 30 percent of its staff. Biogen named Christopher Viehbacher as its new CEO , STAT’s Matthew Herper, Damian Garde and Adam Feuerstein report.
| | | On Thursday, the FDA issued final guidance laying out clarification on the definition of references to “device” and “counterfeit device.”
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