Senate HELP leaders likely to introduce user fee bill today

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

May 27, 2022 View in browser   By Lauren Gardner, David Lim and Katherine Ellen Foley With help from Adam Cancryn and Sarah Owermohle Programming note: We'll be off Tuesday for Memorial Day. Prescription Pulse will be in your inboxes on Wednesday. On Tap — Senate HELP's top Republican signals the infant formula crisis could hamper efforts to quickly reauthorize FDA user fees. — The Biden administration revoked a Trump-era rule that would have forced FDA to periodically review hundreds of regulatory documents. — Novavax executives pitch its Covid-19 vaccine two weeks ahead of FDA's vaccine advisory committee meeting to discuss its EUA authorization. It's Friday. Welcome back to Prescription Pulse. Are you as excited about BTS visiting the White House as David's Twitter followers were yesterday? 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).   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     In Congress Sen. Richard Burr wants answers from FDA before its user fee package moves through the chamber. | Getty BURR: FDA FORMULA RESPONSE MAY SLOW UFA PROCESS — Senate HELP ranking member Richard Burr suggested Thursday he may not be as amenable as he once was to quickly moving an FDA user fee reauthorization package through the chamber, given FDA's answers to congressional inquiries about the agency's response to the formula shortage. The North Carolina Republican's comments came at the close of a two-hour hearing in which FDA Commissioner Robert Califf alternately defended his agency's workers while acknowledging shortcomings in its handling of a damning October 2021 whistleblower report of conditions inside Abbott's Sturgis, Mich., plant. Burr told Lauren after the hearing that he still expects the committee to introduce and mark up a bill. But he signaled his support for the measure is far from assured. "How many times can you ask for less accountability and more money? And that seems to be what they're asking for with the user fees," Burr told Lauren after the hearing. "Listen, until they square the unanswered questions, let's put it on pause." While the path ahead is murky, the user fee process appears to be moving forward today. "The Committee has reached a deal on the user fee package and expects to release the bill text Friday," a Senate HELP Committee aide told POLITICO late Thursday. CALIFF COMPLETES HILL OVERSIGHT TRIFECTA — Thursday's hearing marked Califf's third appearance on Capitol Hill in one week to explain FDA's response to the formula crisis, which began as a pandemic-linked supply chain issue that snowballed once Abbott's facility was taken offline in February after an agency inspection found multiple strains of a bacteria that's potentially lethal to infants. All eyes on the mailroom: Several senators took Califf to task for FDA's Wednesday testimony before the House Energy and Commerce Oversight Subcommittee when he disclosed that senior agency officials didn't promptly receive the whistleblower complaint due to "mailroom issues." "I'm not blaming the mailroom, but there definitely are problems in the mailroom," the commissioner said, adding that the second issue that prevented leaders from getting the report sooner was a lack of "escalation procedures." Abbott's not ready: Califf insisted that Abbott has a long list of items to take care of before it can reopen the plant, contradicting an executive's testimony Wednesday that the company would be ready "the first week of June." "Now that Abbott has taken into account their own failings, I think they would agree completely with us: They're not ready to open," Califf said, adding the company has known for three months that FDA planned to gain control of its quality system via consent decree. While Califf said Abbott is "doing a good job now," FDA went over a list of "hundreds" of items with the CEO earlier this week that have yet to be fixed. "You just can't open a plant with bacteria growing in it," he said. Califf also pushed back on Burr's assertion that Abbott submitted paperwork on April 8 describing how it would take action to reopen the factory. "That was their first take on corrective action," Califf said, calling it "not an adequate corrective action report." Where to lay blame: Califf said he doesn't think firing people — or "castigating" agency employees — over the issue is "necessarily the solution to a problem like this." "People have died from this. Kids have died," said Sen. Tommy Tuberville (R-Ala.). "Kids have definitely died, but I don't believe there's a direct link between the plant and the sickness of these infants that's been proven," Califf said. Still, he insisted he's intent on reforming the agency. "I wouldn't have come back if I wasn't planning on changing it," Califf said. Biden's support continues: When asked whether President Joe Biden still has confidence in FDA and Califf, White House press secretary Karine Jean-Pierre said Thursday: "Yes, yes and yes." UFA RIDER-WATCH — Several senators introduced bills this week that could potentially hitch a ride on the user fee package. Sens. Tim Kaine (D-Va.), Susan Collins (R-Maine) and Maggie Hassan (D-N.H.) introduced the Interchangeable Biologics Clarity Act, a bill that aims to clarify exclusivity provisions for interchangeable biologics. Sens. Kaine, Hassan, Roger Marshall (R-Kan.) and Bill Cassidy (R-La.) also filed the Biologics Market Transparency Act, which would require biologic manufacturers to let FDA know when a product is coming off the market.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     Eye on FDA HHS ENDS THE SUNSET RULE — The Biden administration is formally withdrawing a Trump-era rule after delaying its implementation twice, Sarah reports. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would have set a 10-year clock on thousands of health regulations, requiring agencies to periodically review them and rescind, amend or extend the policies. The Trump administration proposed the rule in early November 2020, just barely making the cutoff for a rule to be finalized before former President Donald Trump's term ended. Biden health officials almost immediately proposed repealing the rule but opted to delay its implementation amid litigation. Killing the rule would save nearly $70 million over 10 years and "reduce the time spent by the Department performing retrospective assessments and reviews of its regulations" as well as the time outside groups like nongovernmental organizations and state officials spend on assessing and providing input on expiring rules, HHS said in a document published to the Federal Register. "[The] White House has appropriately withdrawn [the] HHS rule that required FDA to routinely re-write even basic, technical regulations; which would have created huge administrative burdens for [the] agency, and uncertainty for industry that rely on stable guidance," Scott Gottlieb, who led FDA under Trump, tweeted Thursday. FDA WARNS COMPANIES AGAINST CBD PRODUCTS FOR ANIMALS — The agency sent out warning letters recently to four companies selling CBD products for food-producing animals, POLITICO's Mona Zhang writes. The agency highlighted concerns about a lack of data on the safety of human food products from animals who have consumed CBD. Coronavirus On June 7, FDA's vaccine advisory committee will consider authorizing Novavax's Covid-19 vaccine. | Manuel Balce Ceneta/AP Photo NOVAVAX PITCHES ITSELF FOR FDA AUTHORIZATION — In a press conference Thursday, executives at Novavax said they expect the company's Covid-19 vaccine will be authorized by FDA and recommended by Centers for Disease Control and Prevention on par with messenger RNA vaccines. FDA's vaccine advisory committee will discuss the company's application for its two-dose Covid-19 vaccine for adults on June 7. "This really opens up the opportunity for us to begin selling the first-ever protein-based vaccine for Covid in the U.S.," said John Trizzino, the company's executive vice president, chief commercial officer and chief business officer. Novavax completed its submission to the agency in January. Data breakdown: In late-stage clinical trials in the U.S. and the U.K., Novavax's Covid-19 vaccine was roughly 90 percent effective at preventing Covid-19 in adults; however, those studies were conducted before Omicron and its subvariants began widely circulating. Immunogenicity data showed that the vaccine would likely generate protection against Omicron variants, too. "I think we're going to be looking at postmarket studies … these are studies we have planned," said Filip Dubovsky, Novavax's executive vice president and chief medical officer. Banking on vaccine hesitancy and boosters: Trizzino said he expects that Novavax's vaccine will play a role in immunizing those who remain vaccine hesitant because of concerns about mRNA vaccines. He added that he expects Novavax's vaccine to be used as boosters. Pharma Worldwide DEMAND FOR MONKEYPOX VAX GROWS IN U.S., EUROPE AS VIRUS CASES CLIMB — The U.S. and countries across Europe are preparing for a worst-case scenario if monkeypox should spread, as public health officials insist there is no reason to panic but cite a growing number of cases on both sides of the Atlantic, POLITICO's Carmen Paun, Krista Mahr and Helen Collis report. Bavarian Nordic, the manufacturer of the monkeypox vaccine Jynneos approved by FDA, told POLITICO that it has received calls from "many, many countries" wishing to purchase its shot. TEDROS REELECTED AS WORLD HEALTH ORGANIZATION CHIEF — Tedros Adhanom Ghebreyesus, Ethiopia's former health and foreign minister, was appointed Tuesday for a second five-year term as the World Health Organization director-general, POLITICO's Ashleigh Furlong reports. Research Corner SURVEY ASSESSES PREVALENCE OF NON-NICOTINE E-CIG USE — A study published in JAMA Network Open showed that in a survey of 6,131 participants ages 13 to 40, roughly 25 percent had used nicotine-free e-cigarettes at least once. Among those who had used non-nicotine vapes, CBD and THC, chemicals found in marijuana, were two of the most common ingredients in non-nicotine vapes, followed by melatonin, caffeine and essential oils. The authors noted that the research community needs to further study non-nicotine e-cig use to understand the potential harms that come from vaping other substances. Quick Hits In conversation with POLITICO's Megan Wilson, JC Scott, CEO of the Pharmaceutical Care Management Association, said he believes that lawmaker scrutiny over pharmacy benefit managers comes from a misunderstanding of how they operate in the health care system. Alex Norcia at Filter obtained documents from FDA's Center for Tobacco Products that suggest the agency could have a plan for some flavored vapes to receive marketing orders — provided manufacturers use age verifications to make sure they only reach adults. Document Drawer FDA will convene the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee on July 28 to discuss skin lesion analyzer technology to detect skin cancer.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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