AUSTIN (AP/KXAN) — The Texas Senate has approved a bill making it easier for terminally ill patients to get experimental drugs that have yet to receive federal approval.
The “Right to Try Act” by Houston Republican Sen. Paul Bettencourt passed 31-0 Thursday and now heads to the House.
The Food and Drug Administration already allows patients with physicians’ permission to get experimental drugs via a “compassionate use” exception. His bill attempts to create an expedited state process.
Bettencourt said it would “get government out of the way” and let patients “fight with any resources they can.”
But he also tweaked his proposal to answer concerns it could allow swindlers with false drugs to prey on desperate patients.
Colorado, Arizona, Louisiana, Michigan and Missouri have already approved similar measures.
A life-saving step or a government overreach
Richard Klein, director of the FDA’s Patient Liaison Program, said Douglas’ proposal is an overreach.
“The agency doesn’t have the authority to require that they make that drug available,” he said.
But should they?
“There are lots of reasons why companies can’t or aren’t willing to make those drugs available,” said Klein. “One of them is the cost of manufacturing. They may not have the facilities or the ability to manufacture enough.
“The uncertainty about how much demand there’s going to be. If you start giving it to somebody, especially with the internet, everybody finds out– and a lot of people want access to it.”
Klein said the FDA supports compassionate use programs and encourages drug companies to have them. But he also said giving incentives for companies to make experimental drugs available before all of the research is complete could create other problems as companies would start to make money from these drugs before they’re FDA approved.
Sloan, the focus of an online campaign to persuade BioMarin to allow her the drug, had said during her fight that there ought to be more middle ground in the debate.
“I’m not trying to get people access to shiny new things before the time has come, but I think there is an ethical and moral imperative on drug companies who are in the business of saving lives to develop meaningful compassionate use policies,” she told KXAN in November 2013.