Congress expected to include leftover FDA bills in lame duck – POLITICO | Team Cansler

BURR, Murray PRESS NEXT ON REMAINING FDA INVOICES — FDA legislation, which fell out of September’s user fee reauthorization package, will likely find a home in a year-end government funding bill after Democrats emerged stronger than expected from the midterm elections.

“In terms of nerd FDA policy, this represents a situation where, even if the Senate isn’t known, by a slim margin we have a Christmas tree situation in the House,” said a former HELP committee aide.

Rep. Frank Pallone (DN.J.) and Cathy McMorris Rodgers (R-Wash.) and Sens. Patty Murray (D-Wash.) and Richard Burr (RN.C.) have pledged to return to the negotiating table ahead of the government funding deadline on December 16 to check the policies left behind, such as B. Provisions to streamline the FDA’s expedited approval process and strengthen clinical trial diversity.

“Hope springs forever and we await what we can do with our colleagues on this,” a Burr spokesman told POLITICO. A Murray aide said the senator “continues to work with Sen. Burr and her House counterparts on strong, bipartisan legislation to be included in a solid year-end package.”

ALL EYES OPEN Arizona,Nevada SENATE RACE — With the Georgia Senate race heading for a Dec. 6 runoff and votes still being tallied in Arizona and Nevada, control of the chamber is at stake. Which party holds the majority in the House of Representatives is also yet to be determined, although the Republicans are expected to edge out the Democrats by a narrow margin.

The health body most likely to see a leadership reshuffle is Senate HELP. Murray is expected to become the top Democrat on the Appropriations Committee and install Bernie Sanders (I-Vt.) to take the HELP helm.

The big question mark: Will Senator Rand Paul take Burr’s place, who is retiring next month, on the GOP side of the podium? Or will he seek to lead Republicans on the Homeland Security and Governmental Affairs Committee, where he could also exercise oversight and subpoena authority over a broader spectrum of Biden administration officials.

The Kentucky Republican told David in September he would decide his next move after the election; whether the GOP controls the chamber probably plays into his calculus. Sen. Bill Cassidy (R-La.) is in the mix to take the top Republican seat on the HELP Committee as Paul strives to become the top HSGAC Republican.

The house: Should Republicans regain the majority, Rep. Cathy McMorris Rodgers (R-Wash.) is expected to take the energy and trade hammer. New Jersey Rep. Frank Pallone will likely remain the panel’s top Democrat.

It is Friday. Welcome to Prescription Pulse. All eyes are on Twitter after fake verified accounts surfaced this week. Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherinefoley).

TODAY ON OUR PULSE CHECK PODCAST, Ben Leonard talks to Alice Miranda Ollstein about his conversation with Cassidy, a telemedicine advocate who has repeatedly warned about hackers targeting hospitals and other healthcare organizations. Also, Lauren Gardner accepts the Pulse Check 60 Second Challenge.

LACK OF BREATHING TUBE THREATS PEDIATRIC PATIENTS — The lack of specialized tracheostomy tubes to help children breathe after surgery could jeopardize the ability of healthcare providers to care for children as they recover from serious illnesses, your host reports.

“In the hospital, you have children who may be on a ventilator longer than usual because they can’t be switched to the tracheostomy tube due to inadequate supplies,” Jeff Shuren, the FDA’s top medical device regulator, said in an interview.

FDA WARNS ANIMAL SEDATANT ON SOME ILLEGAL DRUGS – The FDA on Tuesday told healthcare providers that xylazine — an FDA-approved drug for animals that works as a tranquilizer and pain reliever — may be implicated in fentanyl, heroin and other illicit drug overdoses.

“Xylazine is unsafe for human use and can result in serious and life-threatening side effects that appear to be similar to those commonly associated with opioid use, making opioid overdoses difficult to recover from xylazine exposure to distinguish,” the FDA warning reads. “However, we do not know whether side effects of xylazine can be reversed by naloxone.”

MORE THAN 3 MILLION MINORS USED ​​TOBACCO 2022 THE FEDERAL SURVEY WILL FIND – According to the National Youth Tobacco Survey, more than 3 million middle and high school students have used a tobacco product in the past month, Katherine reports. E-cigarettes were the most popular product among middle and high school students, with nearly 2.6 million regular users. Approximately half a million students reported consuming cigars and 440,000 students reported smoking cigarettes.

The CDC and FDA, which jointly author the report annually, said this year’s NYTS cannot be compared to the 2021 survey due to differences in methodology due to the pandemic. In 2021, 2.55 million college 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 previous month.

COMPANIES SEARCH INVESTIGATION AGAINST CALIFORNIA. BAN ON TOBACCO THAT IS TOO FLAVORED — RJ Reynolds, the makers of Newport menthol cigarettes, and several other tobacco manufacturers have filed a complaint against the state, seeking an injunction, saying the ban on flavored tobacco products is unconstitutional, Katherine reports.

Tobacco plaintiffs argue that California cannot legally enforce a ban on flavored tobacco products because it would effectively set a new product standard — something only the FDA can do.

The lawsuit comes in response to a voting action in Tuesday’s midterm elections. Californians voted to maintain a 2020 state law banning the sale of most flavored tobacco products except for loose tobacco and hookah tobacco, as well as premium cigars. The law should come into force in January 2021. The newly passed ban should come into force on December 22nd at the latest.

The California Attorney General’s office derided the complaint as an industry tactic.

NEW TREATMENT FOR ADULT HOSPITALIZATIONS WITH COVID-19 — The FDA on Wednesday granted Kineret emergency use authorization to treat severe Covid-19 in some adults, Katherine reports. In an authorization letter to the drug’s manufacturer, Swedish Orphan Biovitrum AB, also known as Sobi, the agency said the injection could be used to treat adults who are receiving supplemental oxygen, have other markers of increased immune activity and are at risk of to decrease.

PUBLIC HEALTH EMERGENCY CLOCK – The Biden administration is not expected to issue a 60-day notice that the Covid-19 public health emergency is ending until Saturday, 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 obstructed a proposal to waive some intellectual property rights for Covid-19 treatments during the pandemic.

AstraZeneca no longer plans to seek FDA approval for its Covid-19 vaccine due to low US demand for primary serial shots, The Wall Street Journal reports.

Two of Juul’s early investors are providing the company with enough funds to avoid filing for bankruptcy, reports Jennifer Maloney for The Wall Street Journal. The company is also laying off 400 employees, or 30 percent of its workforce.

Biogen has named Christopher Viehbacher as its new CEO, report STAT’s Matthew Herper, Damian Garde and Adam Feuerstein.

On Thursday, the FDA released final guidance clarifying the definition of references to “device” and “counterfeit device.”

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