Trump Signs Misnamed “Right to Try” Law

A LAW FOR WRONGS, NOT RIGHTS

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 the FDA, 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.”

The President, however, touted the new 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 Senate Bill 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!

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[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

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