This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law. The federal government must allow unrestricted possession and use of such treatments by patients certified by a physician as having exhausted all other treatment options.
A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.
The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.
The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.
Seems logical, right?
Well, a whole bunch of folks are against it. Here’s why:
“Patients with terminal conditions who access unapproved therapies outside of clinical trials may be at risk of hastened death or reduced quality of the life that they have left, and deserve protections similar to patients taking part in clinical trials,” the authors wrote.
Andrew Powaleny, a spokesperson for the pharmaceutical industry organization PhRMA, which hasn’t taken a firm stance on the legislation, said, “It is crucial that any right-to-try policy proposals protect patient safety and the integrity of the clinical trial process along with U.S. Food and Drug Administration oversight. PhRMA appreciated the opportunity last fall to work with Sen. Johnson on his proposal and is engaged in an ongoing dialogue with his office and Energy and Commerce Committee Chairman Walden.”
Honestly, (language alert) fuck these assholes.
If a patient is dying and has exhausted all other treatment options when it’s apparent that they have nothing else to lose, then the decision to try something else is up to them, not some bureaucrat in the Imperial City. This is short-sighted beyond belief; I’m as adamantly against snake oil salesmen and Gwyneth Paltrow-style horseshit as anyone, but if a patient is dying and all hope is exhausted, then to hell with it – if there is some new treatment that hasn’t been through all the levels of red tape yet, I say let them try it. These aren’t untried buckets of Paltrow-style woo that’s being discussed, after all. The bill refers to treatments that have at least been through preliminary clinical trials with positive results.
Are these people afraid that the multiple levels of red tape required by FDA might be shown to be excessive?