| | | | |  | | By Lauren Gardner and David Lim | | Presented by |  | | | | | | | 
Rep. Cathy McMorris Rodgers wants to work on a bipartisan drug-shortage package. | Francis Chung/POLITICO | GOOD NEWS, BAD NEWS — The number of national drug shortages dropped last quarter to 300, the lowest level in 18 months, according to a closely watched drug shortage tracker. The decrease occurred over multiple drug categories on the tracker maintained by the American Society of Health-System Pharmacists. But the number of active shortages remains historically high despite the FDA’s efforts to mitigate short supplies of critical medications for cancer and attention deficit hyperactivity disorder. “Until we see a longer trend, I think it’s too soon to really make any assumptions,” said Michael Ganio, ASHP senior director of pharmacy practice and quality. Late last month, FDA Commissioner Robert Califf touted that the common cancer treatment cisplatin is no longer classified as in shortage on the FDA’s drug shortage database. “The FDA will continue to work with drug manufacturers, supply chain companies, health systems and clinicians, including pharmacists, to help restore access to essential cancer treatments and other medicines that are currently in short supply,” Califf posted on X, the platform formerly known as Twitter. Ganio noted that while the supply of cisplatin and carboplatin is in a better spot, cancer drugs continue to be one of the more concerning drug classes plagued by shortages. Lawmakers on Capitol Hill indicated earlier this year that they want to tackle legislation that would stem generic drug shortages. Ganio hopes Congress takes action on legislation after the election. But Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy and Commerce Health Subcommittee, told Prescription Pulse last week it is a “huge disappointment” that Congress has not already passed legislation aimed at stemming persistent drug shortages. “I pleaded — I actually used the word begged, I’m begging you — I said it publicly to my Republican colleagues,” Eshoo said of an effort to focus on pediatric cancer drugs. “Whatever their reasoning, which I really can’t comprehend, they didn’t want to do something about it.” E&C Chair Cathy McMorris Rodgers (R-Wash.) said Thursday that she is still committed to working on a bipartisan drug-shortage package. "The Energy and Commerce Committee has held hearings, and the Majority has crafted draft legislation to address the economic drivers of shortages, which we know are among the root causes of the problem,” she said in a statement. “I will continue working across the aisle to try and find a bipartisan path forward." IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We enjoyed this XKCD comic on metaphors; it’s full of heart. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
| | | | A message from Evernorth Health Services: Medication people can't afford can't make a real impact. That's why Evernorth Health Services is dedicated to improving affordability for patients and the health care system. Including offering a Adalimumab biosimilars with $0 out of pocket, saving patients up to $3,500 annually. Learn more here. | | | | | | | 
Former President Donald Trump reminded those at the RNC about the Right to Try legislation passed while he was in office. | Francis Chung/POLITICO | RIGHT TO TRY SHOUTOUT — In Milwaukee Thursday night, GOP presidential nominee Donald Trump touted the Right to Try law for saving “thousands” of lives. The 2018 law, which Trump pushed for soon after getting to the White House, was intended to provide easier access to experimental treatments for the terminally ill. “They’ve been trying to get that approved for 52 years,” he said during his acceptance speech at the Republican National Convention on Thursday. “We’re saving thousands and thousands of lives, it’s incredible.” He added that Right to Try allows patients to access drugs they would have died without or been forced to travel abroad to get. But, as David wrote earlier this week, a slow uptake is leading one of the law’s biggest proponents to call on Trump to expand the program if he wins reelection.
| | | | The CNN-POLITICO Grill has quickly become a key gathering place for policymakers and thought-leaders attending the RNC in Milwaukee.
On Tuesday, POLITICO and Bayer convened two conversations: a discussion with Sen. John Boozman (R-Ark.) and Rep. G.T. Thompson (R-Pa.) and an executive conversation with Bayer’s Jessica Christiansen, senior vice president and head of crop science and sustainability communications.
The conversations focused on the news of the day in Milwaukee, including deeper discussion centered on the critical challenges faced by the agriculture sector.
CATCH UP HERE | | | | | | | | | 
The FDA plans to open an innovation hub to help drive new treatments for rare diseases. | Sarah Silbiger/Getty Images | FDA PLANS A RARE DISEASE ‘HUB’ — The FDA said this week it plans to launch a rare disease “innovation hub” to coordinate efforts by the agency’s drug and biologics offices to consider products that could help treat those conditions. The agency plans to hold an open public meeting in the fall to take feedback on the hub’s priorities, according to a joint statement from Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research. The driver: Rare disease — which by law is considered a condition that affects less than 200,000 people in the U.S. — is an area with significant unmet medical needs, warranting fresh approaches to expediting safe and effective treatments, the directors said. “We see huge potential in establishing a new model, within the FDA, to leverage cross-agency expertise and greatly enhance our intercenter connectivity to spur the development of treatments for rare diseases,” they wrote. The hub would serve as a facilitator for rare disease patients, advocates and scientists to help them navigate the FDA’s myriad offices, aim to foster collaboration and consistency across centers working on rare disease issues and consider advances to regulatory science that often hamstrings applications for potential drugs, like novel clinical trial endpoints and the use of real-world evidence.
| | | | A message from Evernorth Health Services:   | | | | | BIDEN’S COVID INFECTION — President Joe Biden continues to have “mild upper respiratory symptoms” tied to his Covid-19 infection but does not have a fever, and his vitals “remain normal,” according to a Thursday memo written by his physician, Dr. Kevin O’Connor. Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, said it is a good sign that Biden is taking the antiviral medicine Paxlovid. “His age puts him at a slightly higher risk, and he’s also an important public figure,” Plescia said. “He wants to be affected [by Covid] for as little time as possible, and [Paxlovid] should shorten symptoms and lessen the chance he would have more severe disease.”
| | FDA AUTHORIZES MORE VAPES — A handful of R.J. Reynolds e-cigarette products received marketing authorization from the FDA on Thursday, the latest sign that the agency is working through a number of premarket tobacco product applications. The products in question include the Vuse Alto Power Unit and six tobacco-flavored pods. The agency said it is concerned about youth use of e-cigs, adding that it “placed stringent marketing restrictions” on the products and may suspend or withdraw the authorizations if there is a notable jump in youth use or by former cigarette users. “According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes,” the FDA said in a press release. “However, only 6.4% of students who currently used e-cigarettes reported using tobacco‐flavored products.”
| | | | Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more. | | | | | | | | | NEW DEAL FOR A HUMIRA BIOSIMILAR — Boehringer Ingelheim and GoodRx launched a partnership Thursday, making the unbranded version of BI’s Cyltezo, a biosimilar to anti-inflammatory blockbuster Humira, available on the platform for a discounted cash price. The deal offers high- and low-concentration formulations of adalimumab-adbm to GoodRx customers at $550 per two-pack of prefilled syringes or autoinjectors — a 92 percent discount from Humira’s list price for a month’s worth of medication, the companies said. This product is the first biosimilar available on GoodRx for cash, said Dorothy Gemmell, the company’s chief commercial officer. “We feel like we’re helping to drive adoption of the biosimilar category, which has been challenged historically in the U.S.,” she said. “In a high cost of care area like immunology and the conditions that a Humira treats, it matters.” Background: An industry analysis of data from analytics giant IQVIA earlier this year found that biosimilar competitors to Humira, made by AbbVie, made up less than 2 percent of the market in the past year. Pharmacy benefit managers that negotiate prices for drugs between manufacturers and insurers might be swayed to continue offering brand-name products on preferred lists known as formularies if they can keep snagging rebates and other discounts from drugmakers. “What we’re hoping to see is the market will shift” toward favoring more biosimilars and yield savings to both patients and to the health care system, said Chris Marsh, BI’s senior vice president of value and access.
| | | The FDA issued two warning letters Thursday to makers of plastic syringes made in China, the latest in a string of regulatory actions aimed at ceasing substandard products from entering the U.S. — one to Jiangsu Caina Medical Co. and one to Jiangsu Shenli Medical Production Co.
| | | | A message from Evernorth Health Services: Medication that people can't afford can't make a real impact. Evernorth Health Services is changing that. At Evernorth, we believe costs shouldn’t prevent people from receiving life-changing care. That’s why Evernorth offers eligible patients Adalimumab biosimilars with a $0 copay. Yes, $0. Saving patients up to $3,500 annually. By negotiating with pharmaceutical manufacturers who set prescription drug prices, Evernorth ensures lower costs for clients and consumers, as well as safe access to the medications they need. These life-changing and life-saving therapies can only benefit patients and plans if they can afford them, which makes the role of PBMs even more crucial in ensuring these therapies are accessible and affordable for those who need them most. Learn more here. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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