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The Trump administration announced on Thursday what officials called a “historic” crackdown on the nation’s troubled organ procurement system, pledging stronger oversight, accountability and patient safety reforms.
“Every American should feel safe becoming an organ donor and giving the gift of life,” HHS Secretary Robert F. Kennedy Jr. said during a press conference.
“Yet decades of ignored patient safety concerns have driven more and more Americans off the donor list. Today, under President Trump’s leadership, we are taking bold action and historic action to restore trust in the organ procurement process.”
For the first time in U.S. history, the Department of Health and Human Services is moving to decertify an organ procurement organization (OPO) mid-cycle. (OPOs are typically only assessed during a scheduled review period.)
“The Life Alliance Organ Recovery Agency based in Miami, Florida, has a long record of deficiencies directly tied to patient harm,” Kennedy said. “Staffing shortfalls alone may have caused … as many as eight missed organ recoveries each week. Roughly one life lost each day.”
Kennedy shared the story of his nephew Michael, who had cerebral palsy and died at age 20. His organs went on to save multiple lives.
The secretary urged Americans to think ahead, claiming that organ donation is something “all of us need to think about.”
“It’s an extraordinary gift and will give meaning to our lives. No matter how different we are on the outside …we’re all the same inside, and we can give the gift of life to each other.”
Oz also noted that there are 100,000 people currently waiting for organs in America.
“While I’m speaking, another person will be added to that list. During this press conference, someone waiting for an organ is going to die,” he said.
He noted that 28,000 donated organs go unmatched and discarded each year, and that every missed donation is a lost opportunity to save a life.
Dr. Marty Makary, commissioner of food and drugs at the U.S. Food and Drug Administration, called the waste of organs “a tragedy.”
“For too long, we’ve seen conflicts of interest … gaming of the system, inefficiencies … Today is the first time ever that we have seen an action initiated against an organ procurement organization,” Makary said.
Thomas J. Engels, administrator of the Health Resources and Services Administration, said modernization is already underway, claiming the organization has opened a “direct reporting channel for misconduct and safety concerns.”
There will also be new investments into the programs, including $25 million to support living donors by covering nonmedical costs like lost wages, travel and childcare.
“There’s a new sheriff in town, and we’re coming for them if they don’t take care of the American people.”
Experts also pointed to the future of transplant science, citing recent moves to green-light the first clinical trials for xenotransplantation (animal-to-human transplants). They also discussed how 3D printing of organs may one day be viable.
Oz said the new reforms send a tough message to other organ procurement organizations.
“There’s a new sheriff in town, and we’re coming for them if they don’t take care of the American people.”
The Life Alliance Organ Recovery Agency in Miami, Florida, posted the statement below on its website in response to the HHS announcement.
“We are aware of the decision issued today by the Department of Health and Human Services and of the agency’s investigations into organ procurement practices across the country. We will cooperate fully with HHS to ensure a smooth transition and will not appeal. We hope that other OPOs follow suit in putting patients first. Our focus remains on protecting the dignity of donors, supporting their families and advancing the life-saving mission of organ transplantation.”
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