FDA lays out device cybersecurity requirements

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Mar 31, 2023 View in browser   By David Lim and Katherine Ellen Foley With Megan R. Wilson Driving the Day New guidance requires medical device manufacturers to ensure they can monitor and address cybersecurity threats as a prerequisite for FDA approval. | AP Photo | AP Photo SECURE THOSE MEDICAL DEVICES — Manufacturers of medical devices must now show regulators when they apply to the FDA for authorization that they can monitor and address cybersecurity threats once products are on the market. The new policies — part of the omnibus spending package passed late last year — are outlined in guidance published this week and include a requirement to provide the FDA a “software bill of materials,” which could help device makers be prepared to respond in the event of an attack. Grace period: Though the mandate was effective this week, the FDA said it will not generally refuse premarket submissions from device companies until Oct. 1 that do not comply and will work with firms to adhere to the requirements. Industry reaction: The Medical Imaging & Technology Alliance said it welcomes the FDA’s flexibility on implementing the cybersecurity provisions. “Improving cybersecurity for post-market medical imaging technologies continues to require a shared commitment by all who interact with a device,” MITA spokesperson Eric Hoffman said in an email. “This includes utilizing the latest [original equipment manufacturer] software updates, leveraging coordinated vulnerability disclosure practices and ensuring companies whose technicians maintain and repair FDA-regulated medical devices are known to the agency and adhere to their regulations.” IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Reminder for those who live in D.C. that today is the last day the city’s Covid-19 centers will be open. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Alice Miranda Ollstein about the proposals that some Republican governors and lawmakers in staunchly conservative states have referred to as a “new pro-life agenda” for the post-Roe era — promoting sex education, government welfare and more birth control. Listen to today’s Pulse Check podcast Eye on the FDA While the FDA has approved over-the-counter Narcan, its price tag is still to be determined. | Matt Rourke/AP Photo OTC NARCAN AT  WHAT COST? The FDA green-lit Emergent BioSolutions’ bid to market Narcan, a naloxone nasal spray, without a prescription. Public health advocates celebrated the decision, which they say will increase access to the opioid overdose reversal drug, but FDA is now worried about a key question around access: What will the price be? Emergent Bio has stayed mum on what it will charge for a two-pack of Narcan, saying it is still working with retailers on the final price. As a prescription, the two-pack Narcan costs about $70, though over-the-counter prices may vary depending on markups or insurance coverage. Many insurance plans don’t cover nonprescription drugs, which worries some public health researchers who think Narcan will remain out of reach for those who inhale or inject drugs and are most likely to experience an overdose. “The antidote needs to be cheaper than the price of the dope,” Nabarun Dasgupta, innovation fellow for the school of public health at UNC-Chapel Hill, told Katherine. “Until the price is less than a bag of fentanyl and heroin, the idea that someone will buy this off the shelves is effectively a pipe dream.” Emergent estimates it will begin populating store shelves with Narcan by this summer. A competitor on the horizon: The FDA is reviewing a bid from Harm Reduction Therapeutics to market its naloxone nasal spray without a prescription. The nonprofit company, which receives funding from oxycontin maker Purdue Pharma, pledged to charge slightly above the manufacturing cost, which is about $36 for a two-pack. The FDA is slated to make a decision on that product by July.   JOIN POLITICO ON 4/5 FOR THE 2023 RECAST POWER LIST: America’s demographics and power dynamics are changing — and POLITICO is recasting how it covers the intersection of race, identity, politics and policy. Join us for a conversation on the themes of the 2023 Recast Power List that will examine America’s decision-making tables, who gets to sit at them, and the challenges that still need to be addressed. REGISTER HERE.     Drug Pricing TIMING THE INFLATION REDUCTION ACT — One possible unintended consequence of Medicare drug price negotiations is an incentive for drugmakers to time the filing of new drug and biologic applications to the FDA so that new medicines can get extra exclusive time on the market before they can be considered for negotiations. John Murphy, chief policy officer at trade lobby Biotechnology Innovation Organization, said a number of law firms are already eyeing the Inflation Reduction Act’s annual selection date for the list of drugs Medicare will negotiate prices on when advising drugmakers on portfolio planning. If enough drugmakers alter their behavior, that could lead to a “bolus of applications” during certain periods of the year, according to Eva Temkin, a pharmaceutical attorney at King & Spalding and former director for policy at the FDA’s Office of Therapeutic Biologics and Biosimilars. CMS and PhRMA say they are not worried about the potential issue. Review timelines can be unpredictable, and the FDA may extend review periods if logjams arise. “Drugmakers can try, but if they delay filing to try to get past February and then there is an extension or something, they’ve just burned time on the market where they could have been making money in the hopes that they might gain a few more months in a decade,” said Remy Brim, a lobbyist at BGR Group and former senior FDA policy adviser to Sen. Patty Murray (D-Wash.). “That seems like a hard trade.” OPEN SEASON ON PBMS — A dueling set of events Thursday brought into focus the growing momentum for legislation this year targeting the so-called middlemen of the pharma industry. One took place on Capitol Hill and the other at a nearby hotel where PhRMA CEO Steve Ubl lambasted the rebating practices of pharmacy benefit managers. “I want us to look back and say that today was the day that we started to get this fixed,” said Senate Finance Chair Ron Wyden (D-Ore.) at a hearing in the morning. He's working with the panel’s ranking member, Sen. Mike Crapo (R-Idaho), on a bill — but lobbyists and staffers tell Megan it’s still in the early phases. Taking action on PBMs, which negotiate discounts on medicines with drugmakers and manage drug benefits for insurance plans, has become one of the few bipartisan efforts gaining traction in Congress. “The system is broken and needs to be reformed,” Ubl said. “Three PBMs control 80 percent of the market; they’re vertically integrated with health plans. They do play a role in restraining costs, but there’s very little evidence that the fruits of their efforts are actually translating into lower costs for consumers.” But PBMs argue that they play a key role in negotiating down drug costs and want lawmakers to pursue a bipartisan set of patent bills that could boost competition in the pharmaceutical marketplace, with the industry's main trade group saying that the Finance Committee largely ignored the role drugmakers play in high prices. “I liken [PBMs] to the Rodney Dangerfield of health care; they get absolutely no respect,” Lawton Robert Burns, a professor at the Wharton School of the University of Pennsylvania, said at the hearing. “They're the whipping boys — in other words, the people who take the rap and get spanked for evil doings of others.” In Congress HARRIS: DON’T EXPECT FDA FUNDING AT 2022 LEVELS — The top Republican on the House Appropriations Subcommittee in charge of fiscal 2024 FDA funding told POLITICO this week that it is unlikely that the panel will push to cut the agency’s funding to fiscal 2022 levels, citing its responsibilities overseeing the safety of drugs and food. “I would be shocked if it were funded at exactly that level, which of course is the straw man that the minority party set up — that all of a sudden that we are going to fund everything at [fiscal 2022] levels, and let’s make assumptions that they are across-the-board cuts,” Rep. Andy Harris (R-Md.) said. “That’s not the way Congress usually operates.” Despite Democrats’ and Republicans’ harsh questioning of FDA Commissioner Robert Califf on the FDA’s most recent response to an ongoing infant formula crisis, Harris believes Califf is up to the task of addressing shortages and other challenges. “The commissioner will have to address some ongoing problems that appear to be present with the infant formula, production, distribution and safety,” Harris said. “But look, Dr. Califf, I think, is up to that task, and I hope that he solves that problem.” In the Courts JUDGE STRIKES DOWN KEY PART OF ACA — A Texas federal judge ruled Thursday that employer health insurance and the Affordable Care Act will no longer need to cover free mammograms and colonoscopies and access to certain preventive therapies, POLITICO’s Alice Miranda Ollstein reports. In his ruling, District Court Judge Reed O’Connor said the U.S. Preventive Services Task Force, a group of independent medical experts who advise the government, acted unconstitutionally by mandating coverage of certain screenings because the experts are not federal employees and weren’t properly appointed by Congress or the president. He also ruled that plans didn’t have to cover the HIV prevention medication PrEP because doing so could violate the religious rights of employers. Document Drawer The FDA published draft guidance Thursday on involving children in clinical research not approved by an institutional review board. Also on Thursday, the FDA published draft guidance on establishing predetermined change control plans for artificial intelligence and machine learning–enabled device software.   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.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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