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Legal Right to Try

Legal Right to Try

Legal counsel is another avenue to explore as hospitals will likely be using their own hefty legal resources to defend their decisions. You are likely going to need to file an emergency injunction to force the hospital to provide the treatment you request, but it isn’t guaranteed the courts will side with the patient.

One avenue of legal exploration is the federal “Right to Try Act” (H.R.878/H.R.2368/S.204), which was signed into law May 30,2018 and authorizes the use of unapproved medical products by patients diagnosed with a terminal illness. There have been cases where the alternative therapies are approved given this act, but it is not guaranteed that the hospital or courts will ultimately acknowledge this route.

Along with the Federal Right to Try law, individual States may also have a state Right to Try statute. Many state Right to Try statutes is somewhat different from federal law. They may provide you and your loved one with slightly diverse (and sometimes more inclusive) rights in this area. The wording is important, and the legal counsel you confer with will be able to compare the state and federal laws and advise you on which is the better avenue to pursue.

Federal Right to Try Act of 2017

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.

Legal Right to Try

Congress Bill Info:

H.R.878 - Right to Try Act of 2017

H.R.878 - Right to Try Act of 2017

Congress.gov

FDA document – Right to Try Act:


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