The impact of FDA’s new blood donation guidelines

Presented by Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

May 16, 2023 View in browser   By Katherine Ellen Foley Presented by Pharmaceutical Care Management Association With Alice Miranda Ollstein Driving the day Some blood centers aren't convinced that the FDA's new blood donor guidelines will reap a surge of donations. | AP Photo/David Goldman LOOSER GUIDELINES, MORE DONATIONS? While blood centers nationwide applaud the FDA’s rule that allows more gay and bisexual men to give blood, blood banks are skeptical that it will lead to a major increase in eligible donations. Jed Gorlin, the chief medical officer of America’s Blood Centers, a group of independent blood centers that make up roughly 60 percent of the nation’s blood donations, pointed to Canada and the U.K. as case studies. Those countries enacted similar policies last year and allowed men who have sex with men to donate blood without abstaining from sex if they have been in a monogamous relationship for more than three months. “They honestly did not see a dramatic change in donation,” Gorlin told Prescription Pulse. But he noted many universities and other key blood donation sites felt the FDA’s previous policy — requiring all LGBTQ men to abstain from sex for three months before donating blood — was discriminatory and failed to recruit blood donors as a result. With the new policy, there may be more donors from these institutions in general. “The new recommendations have taken a quantum leap in addressing the core issue of discriminatory policies toward MSM,” a senior Biden administration official not authorized to speak on the record told Prescription Pulse about the rule change last year. But not everyone thinks the new guidelines fight stigma enough: The FDA requires those who have had a new partner or multiple partners in the last three months to defer donating. It also prohibits LGBTQ men from donating blood if they take pre- or post-exposure prophylaxis against HIV. “Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma,” Sarah Kate Ellis, president and CEO of GLAAD, said in a statement. The Biden administration stressed that changes to the guidance are not final. “As knowledge about the window period between infection and a positive HIV test becomes more clear in PrEP users, guidance may change as dictated by the evidence,” the White House official said. What’s next: Gorlin expects ABC’s centers to take three to six months to adopt guidelines and screening practices. The Red Cross said it would adopt the measures “as quickly as possible.” IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Your host today — a summer-loving kid at heart — is thrilled that D.C. has opened some of its splash parks early in anticipation of warmer weather. Send news, tips and favorite ways to keep cool to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with AI entrepreneur and NYU professor emeritus Gary Marcus, who will testify before the Senate Judiciary Subcommittee on Privacy, Technology and the Law today as lawmakers consider regulating artificial intelligence in health care. A message from Pharmaceutical Care Management Association: Don’t let their smoke and mirrors fool you: high drug costs start and end with big drug companies. While pharmacy benefit companies are lowering costs, drug companies are busy blaming everyone in the supply chain but themselves to avoid culpability for the affordability challenge some patients face. Without more competition and accountability, big drug companies will continue to abuse the patent system and block affordable alternatives – making life-saving medications unaffordable for American families. Learn more.   Listen to today’s Pulse Check podcast Tobacco An FDA advisory committee will discuss regulatory standards for tobacco products. | Getty FDA’S TOBACCO ADVISERS CONVENE — The FDA’s independent advisory committee on tobacco products will meet this week for the first time since February 2020. The meeting, recommended by the Reagan-Udall Foundation in its review of the FDA’s tobacco regulatory branch in December, centers on a proposed regulatory standard on tobacco product manufacturing. Some tobacco-control experts argue that this public meeting skirts the more contentious issues on the Center for Tobacco Products’ plate — including marketing applications for e-cigarettes, removing illegal vapes from retail shops and developing a rule that would cap the nicotine level in all cigarettes. “There are not many major targets that [the CTP] is finding it easy or effective to talk about,” Cliff Douglas, the director of the University of Michigan’s Tobacco Research Network, told Prescription Pulse. “They’re having a hard time righting the part of their regulatory ship that is sinking.” TOBACCO REGULATOR UPDATES E-CIG INDUSTRY — Brian King, the head of the FDA’s Center for Tobacco Products, is slated to update top e-cigarette and tobacco officials today on the agency’s progress in regulating new tobacco products — including vapes. The agency said Friday it had rejected applications from 10 more e-cigarette companies responsible for 6,500 vapes still on store shelves. The agency has gone through more than 99 percent of e-cigarette marketing applications, though it is still weighing applications from major market players like R.J. Reynolds.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     In the Courts ABORTION PILLS BACK IN COURT — The next chapter in the long-brewing fight over access to mifepristone kicks off Wednesday, Alice reports. The 5th Circuit Court of Appeals hears arguments over the FDA’s approval of the drugs more than two decades ago. Arguments will likely center on whether the agency followed the law when it first approved mifepristone and legally lifted restrictions on it later. The court will also scrutinize whether anti-abortion doctors challenging the pills have standing to sue and the right to question a 20-year-old federal agency decision and whether the Texas court overstepped in ordering the pills be taken off the market. SCOTUS WON’T HEAR GENERIC LABELING CASE — The Supreme Court said Monday that it would not consider arguments from Teva Pharmaceuticals over so-called skinny labeling for generic products. Skinny labeling allows generic drugs to come to market for some — but not all — indications of patented drugs. The practice’s supporters say it allows those cheaper drugs to come to market faster. Teva had argued that a lower court’s ruling in GSK’s favor could hurt future generic drugs. In March, the Biden administration urged SCOTUS to take the case. The ‘skinny’: Teva asked the high court to overturn a 2021 decision from the Court of Appeals for the Federal Circuit that ordered the company to pay GSK $234 million in damages over patent infringement. GSK successfully argued before a jury that Teva unlawfully marketed its generic version of a beta-blocker to treat congestive heart failure, which it was not approved to do. GSK’s patented version of the drug was approved for three indications, including heart failure. Teva’s generic was approved for two indications that did not include congestive heart failure.   A message from Pharmaceutical Care Management Association:   Eye on the FDA PFIZER’S INFANT RSV VACCINE IN HOT SEAT — On Thursday, the FDA’s independent advisory committee will discuss the first respiratory syncytial virus geared at protecting infants. Earlier this month, the agency approved the first RSV vaccine for older adults. Infants, like older adults, are at a uniquely high risk of developing severe disease. Pfizer’s vaccine candidate is administered to pregnant individuals in their second or third trimesters. In late-stage clinical trials, the candidate was more than 80 percent effective against severe lower respiratory tract disease in infants up to 3 months old. It was about 70 percent effective at protecting against severe disease in children up to 6 months old. What’s next: The FDA will decide on Pfizer’s RSV vaccine in August. The agency is expected to decide on Pfizer’s RSV vaccine for adults 60 and older by the end of this month. Pharma Moves Matthew Myers is stepping down as the president and CEO of the anti-youth tobacco advocacy group, the Campaign for Tobacco-Free Kids, effective June 30. He will stay on as an adviser to Yolonda Richardson, CTFK’s executive vice president for global programs, who will replace him starting in July.   DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW.     Quick Hits A rare genetic mutation stopped a second man from developing early-onset Alzheimer’s disease — and challenges the theory that amyloid plaques lead to cognitive decline, Sara Reardon writes for Nature. Monica Bertagnolli, the head of the National Cancer Institute, will oversee billions in research grants if she’s confirmed to head the National Institutes of Health, POLITICO’s Erin Schumaker reports. A message from Pharmaceutical Care Management Association: Big drug companies choose to set unaffordable prices for many Americans – then add insult to injury by blocking competition in the prescription drug market to maximize their profit, and drive drug costs higher at the expense of patients. Rather than limiting choice for employers and restricting options for achieving savings, Congress should act to strengthen competition in the market, and end big drug companies’ egregious abuse of the patent system that blocks affordable alternatives – such as generics and biosimilars – from entering the prescription drug market. Patent thickets on five of the 10 top-selling drugs in the U.S. resulted in more than $500 billion in additional sales, and patent abuse blocking biosimilars from the market alone will cost patients an estimated $30 billion over the next decade. While big drug companies are focused on profits, pharmacy benefit companies are driving costs down and securing savings for patients, employers, and taxpayers.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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