FDA Finalizes Blood Donation Guidelines
On Thursday, recommendations for evaluating blood donor eligibility using individual risk-based questions—identical for all potential donors regardless of gender, sex, or sexual orientation—to decrease the risk of transfusion-transmitted HIV were finalized, reported the FDA. The guidance also revises donor deferral recommendations for individuals at greater risk of transmitting HIV and suggests that establishments that collect blood correspondingly update their donor educational materials and donor history questionnaire. This new policy strikes down decades-old guidance for time-based deferrals and screenings specific to men who have sex with men (MSM) and women who have sex with MSM.
Pfizer CEO Criticizes US Drug Price Plan
Albert Bourla, DVM, PhD, CEO of Pfizer Inc, called US agendas to negotiate Medicare drug prices “negotiation with a gun to your head” and said he anticipates drugmakers to sue to stop the process, according to Reuters. “It is not negotiation at all. It is price setting,” said Bourla in reference to President Joe Biden’s drug pricing reform, part of the Inflation Reduction Act. The pharmaceutical industry says the law, passed in 2022, will result in a loss of profits that will compel drugmakers to retreat on developing groundbreaking new treatments even while it has potential to save many Americans $25 billion by 2031 with the help of price negotiations.
Drug Shortages May Increase
COVID-19 curbed the US health care supply chain, but it was going to pieces long before, say experts, reported the Center for Infectious Disease Research and Policy. Additionally, drug and medical device shortages could worsen, said Tammy Beckham, DVM, PhD, associate director of the FDA’s Resilient Supply Chain Program at the Center for Devices and Radiological Health. Issues that have afflicted the health care industry for years, such as scant raw materials and quality problems, won’t disappear with the end of the COVID-19 public health emergency, and Beckham said that CDRH is working to remedy the situation.