Trump Signs Misnamed "Right to Try" Law
“Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it’s going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time.” Donald J. Trump
President Trump signed the so-called Right to Try bill, S-204, passed by Congress, into law today.
The website for the 115th Congress describes the law with this official summary: [1]
“This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website. The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”
The new law provides that any patient diagnosed with “a life-threatening disease or condition…” who has “exhausted approved [by whom?] treatment options…” as certified by a physician who is not compensated by a drug company, may benefit from the experimental treatment’s exemption from FDA licensing.
The law also correctly requires, in section (1)(C) that the written Informed Consent of the patient or guardian be obtained.
Unfortunately the new law restricts its benefits only to pharmaceutical drugs that have already gone through FDA-approved Phase 1 testing or certain other procedures. This law does not apply to the many natural remedies or to medicines used in other countries. [2]
The law specifically exempts drug companies from liability for harm to the patient and provides that the FDA may not, in normal circumstances, use the outcome of the Right to Try to delay or deny drug approval. The law concludes with a Statement of the Sense of the Senate that the the law does not “establish a positive right to any party or individual…” and that any “use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk…”
Thus, what appears on first look as an act of compassion by Congress and the Administration, when viewed more closely, is a law made to protect drug companies without securing for Americans the Right to Try natural remedies that are not subject to FDA approval in the first place!
This new law does not expand Freedom of Choice and is at best a half-way measure that might benefit a few individuals. It does not address the excess power already possessed by an Agency of which former Congressman Ron Paul once said, to the effect, “the more power it has, the more power it has to abuse.”
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Also posted at: http://www.opensourcetruth.com/trump-signs-misnamed-right-to-try-law/
[1] https://www.congress.gov/bill/115th-congress/senate-bill/204
[2] There are other legal provisions which do allow some limited access to other remedies. I have written about two of them here:
Medical Foods: http://vitaminlawyerhealthfreedom.blogspot.com/2013/05/medical-foods-under-orphan-drug-act.html
Personal Importation: http://www.lifespirit.org/perimport.html
Source: http://vitaminlawyerhealthfreedom.blogspot.com/2018/05/trump-signs-misnamed-right-to-try-law.html
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Figures big Pharma gets liability protection, like they enjoy on Autism Inducing “Vaccines”
The very first thing Trump did when elected was to give HUGE tax breaks to Big Pharma, Big Oil and Big Banks. We know where his loyalties lie.
We do not need corporations to tell us how or what we can do try to survive. Natural God given rights is the right to make our own chose without corporations telling us what is a statute they passed that limits what we can try to us to survive.
Next they will outlaw, with statues backing soda if it fights cancer.
If there is no profit in it, it will be made illegal by the fake law called corporate statues.
More BS to keep you on Big Pharma’s list. Band together and keep fighting for hemp. People using hemp have been dropping Big Pharma products. It has been reported by an insider that pot destroys programming. 3rd this cash cow has been used by the negative forces of the government long enough. Moneys collected from the sales is second to fines and court fees and attorneys. The moneys collected goes into pockets for nefarious reasons while the cost of incarceration is passed onto the tax payer. A type of money laundering as money in the system is converted into debt. It is 1 of the 100s of sources that are added to the national debt. the 4th reason is another elephant in the room, prohibition allows them to control prices of this “control substance”.
The entire process is crooked from start to finish.