At National Review Online, Jillian Kay Melchior, reports on a cancer patient who has run out of therapies. There are medicines under development that might help, but drug-makers won’t let her have them under the FDA’s “compassionate use” doctrine.
Clinical trials accept only “typical” patients — Mikaela’s rare form of kidney cancer has ruled her out, but for others in her situation, complications as common as diabetes or high blood pressure could also be reason for ineligibility. And the Food and Drug Administration’s approval process for “compassionate use” of an experimental drug outside of clinical trials is extremely arduous.
First, a pharmaceutical company has to be willing to provide the experimental drug — a high-risk proposition, given that an atypical result in an atypical patient can prompt the FDA to delay approval or require significant and expensive additional testing…And approval from a pharmaceutical company is just the first step. Next, patients and doctors must fill out an exhaustive paperwork disclosure to submit to the FDA, which is estimated to take at least 100 hours to complete. The FDA then begins a review, which is supposed to take no longer than a month — but if the agency’s reviewers have any additional questions or need more information, that 30-day clock is reset. Finally, the hospital’s institutional review board has to give approval — and if a patient is being treated at a small hospital that lacks such an administrative panel, the case has to be reviewed by a bigger facility, often one unfamiliar with the patient.
The FDA bottleneck has been a frequent topic of this blog (e.g. here). Congress has never come close to fixing this problem. So, the Goldwater Institute has developed a new approach: State-based “right to try” laws:
In the past week, the state houses in Louisiana and Colorado both unanimously passed Right to Try bills. In Missouri, the bill has won unanimous support in both the House and a Senate subcommittee. Another bill won approval in the Arizona house recently, and the state senate is expected to vote on the legislation in the next few weeks. “You shouldn’t be putting a bureaucrat in the middle of medical decisions, especially when you’re talking about terminal patients,” says Christiana Corieri, a health-care policy analyst for the Goldwater Institute, which helped draft the legislation. “There’s no right that could be more fundamental than the right to try and save your own life.”
Will these laws hold up? There’s nothing the Goldwater Institute relishes more than a constitutional challenge.