The FDA says it has allowed tens of thousands of patients to receive unapproved drugs to treat cancer, HIV/AIDS and heart disease for decades, but its guidelines for gaining access to such drugs were not explicit enough and excluded too many patients.
The agency claims its move to increase patient access to medicines that have not yet been proven safe is meant to address "inequities in access" that, in the past, have possibly caused seriously ill patients to be denied experimental drugs.
"We expect that clearly articulating procedures and standards for expanded access will result in more patients with serious or immediately life-threatening diseases or conditions getting the earliest possible access to these therapies," the FDA said.
According to Dr. Rachel Behrman, deputy director of the FDA's office of medical policy, experimental drugs will only be used to treat the worst diseases.
"We are not talking about the temporary relief of minor pain," Behrman said. "We are talking about serious diseases."
Supporters of the FDA's decision to increase access, such as Frank Burroughs of the Abigail Alliance for Better Access to Developmental Drugs, say the FDA has not done enough to help patients gain quick access to unapproved drugs. Burroughs says his daughter, Abigail, died in 2001 when she was unable to obtain the experimental cancer drug Erbitux.
However, critics of the new policy say the FDA may be harming patients far more than helping them.
Consumer advocate Mike Adams, author of "Take Back Your Health Power," said the practice would be "disturbing" if the FDA passes it.
"It effectively creates a loophole that allows drug companies to avoid the entire drug approval process and start treating large numbers of patients like experimental guinea pigs," he said.
According to Dr. Sidney Wolfe, editor of WorstPills.org, "None of these drugs do we know are safe and effective. You may be doing people more harm than good."
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