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Investigational Drug Use Act

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Investigational Drug Use Act

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Investigational Drug Use Act

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Question:
Summarize the content of the Bill. Clearly state whether there is an appropriations component and if so, include the associated Appropriations Bill. Describe the circumstances that precipitated introduction of this Bill (office of the Senator who introduced the Bill will be able to help you but this should be in the bill timeline found on the website. What amendments/revisions were included? Why? What significance does this Bill have for nursing, healthcare, and consumers? Cite references in the paper. Interviews may be included in the body of the paper but are not required. References should be credible, professional, and evidence-based. The number of references should be sufficient to support complete discussion of the topic .
 
Answer:

The Investigational Drug Use Act is created through LB 804 which has been termed also as the right to “Right to try” (“Hilkemann’s Highlights « District 04 Blog”, 2016). The bill does not seem to have any appropriation component. The patients who are eligible are allowed under this bill to be treated with any type of drug that has completed the first phase of the clinical trial but that has not yet been approved for general use by USFDA. The foundation was laid down by this bill to nullify some rules that the Food and Drug Administration had laid down for practice which denied access to treatments which were experimental be patients who were terminally ill. This bill gives access to terminally patients of medicines that have not been approved as yet by the FDA. The FDA expanded access program would be bypassed by LB804 and patients would be allowed to obtain experimental drugs from the manufacturers without obtaining first an approval from the FDA. There is direct conflict of this procedure with “federal expanded access program” and aims to set the stage for nullification of the same in practice. It was stated by Darcy Olsen the president of Goldwater Institute that the government should not be asked for permission by the Americans for trying to save their lives (Stone, 2016). He also further stated that (Olsen, 2015). They should be given the ability to be able to work with their doctors in a direct manner and decide on a treatment that could potentially be life saving and which they have the willingness to try. This exactly is what is attempted to be achieved by Right to Try. There is protection that is provided to the health care providers under law with a prohibition against revocation of license or issuance of any sanction which is based on the issuance or recommendation of such treatments that are investigational. In part the LB 804 reads as that notwithstanding anything that which has been mentioned under any provision of law, there shall not be revocation, failure to renew, or any action taken by the board of medicine against the license of the physician, solely based on the recommendation of the physician to a patient that is eligible or prescription of a treatment with an investigational biological product, drug or device.
The lawsuits against physicians in addition who comply with terms that have specified under the said LB are prohibited.
Although bills such as these address only on small aspect of the regulation of FDA, a clear model is provided by it which demonstrates as to the manner in which the federal state statutes are to be nullified which is in violation of the Constitution. It was stated by Mike Maharrey of the Tenth Amendment Center that “The Right to Try Act is a no-brainer” (Maharrey, 2016). He further stated that  when a person is dying the FDA would rather let the person die than try and save is policy that is most inhuman. Every state should nullify the FDA like this.”
This legislation seeks to provide protection to the medical practitioners, including those involved in nursing, and protects them against the license being revoked or sanctions being issued in their favor due to usage of medicinal drugs for the protection of terminally ill patient.
 
References
Hilkemann’s Highlights « District 04 Blog. (2016). News.legislature.ne.gov. Retrieved 17 September 2016, from https://news.legislature.ne.gov/dist04/2016/01/22/hilkemanns-highlights-10/
Maharrey, M. (2016). Signed into Law: Connecticut Right to Try Act Rejects Some FDA Restrictions on Terminal Patients. Tenth Amendment Center Blog. Retrieved 17 September 2016, from https://blog.tenthamendmentcenter.com/2016/06/signed-into-law-connecticut-right-to-try-act-rejects-some-fda-restrictions-on-terminal-patients/
Olsen, D. (2015). The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Nee.
Stone, J. (2016). Righttotry.org. Retrieved 17 September 2016, from https://righttotry.org/gov-brown-should-sign-ab-159-the-right-to-try-bill/

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