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“Right to Try Act ” ,”Terminally Ill” a new tool to make potentially lifesaving decisions about their treatment

prescription-drugs

“People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home.”

President Donald J. Trump 

May 31,2018

the staff of the Ridgewood blog

Washington DC , in a historic move and another campaign promise met Congress passed the Right to Try Act of 2017, sending a priority bill to President Donald J. Trump for his signature.
The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Belllina Right to Try Act of 2017” passed Congress on May 22, 2018.
The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.
Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.
The bill requires any manufacturer or sponsor of an eligible investigational drug to report to the FDA on any use of the drug on a “Right to Try” basis.
The FDA will post an annual summary report of “Right to Try” use on its website.
The bill limits the liability of drug sponsors, manufacturers, prescribers, or dispensers that provide or decline to provide an eligible investigational drug to an eligible patient.

A RIGHT TO LIFE: Right to try legislation returns treatment decisions back to patients, giving them the right to make healthcare choices that could save their lives.
“Right to Try” gives the over 1 million Americans who die from a terminal illness every year a new tool to fight and make potentially lifesaving decisions about their treatment.
According to the National Cancer Institute, an estimated 609,640 Americans will die from cancer alone in 2018.
Prior to this legislation, options for terminally patients who had exhausted all treatment options were extremely limited:
Many terminally ill patients were considered too sick for clinical trials of new medication. In fact, only 3 percent of cancer patients today are enrolled in clinical trials.
The FDA’s “compassionate use” application is complicated and time-consuming, resulting in only about 1,200 approved applications per year.
With President Trump’s signature the Federal government joins with 40 States that have approved the right of terminally ill patients to try potentially lifesaving drugs.

MAKING HEALTHCARE WORK FOR AMERICANS: Every day, President Trump is working to fix America’s broken healthcare system and return healthcare decisions to individuals.
On May 11, 2018, the President issued his blueprint to lower prescription drug prices, taking action to put American patients first.
President Trump has signed multiple Executive Orders and approved new funding to target the scourge of opioid abuse and is taking the fight to drug abuse across the Nation.
In March 2018, President Trump’s Administration released the President’s plan to put patients back in charge of their own health information.
President Trump is putting healthcare decisions back into the hands of Americans by repealing Obamacare’s individual mandate, ending the healthcare rationing board, and providing more affordable options outside of Obamacare.

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New Jersey State Attorney General Proposes new rules to minimize the potential for conflicts of interest between prescribers and pharmaceutical manufacturers

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October 11,2017
the staff of the Ridgewood blog

NEWARK NJ, The Attorney General is proposing new rules concerning limitations on and obligations associated with the acceptance of compensation from pharmaceutical manufacturers. The public may submit written comments to this proposal through December 1, 2017.

The proposed rules establish principled standards to minimize the potential for conflicts of interest between prescribers and pharmaceutical manufacturers to ensure that patient care is guided by the unbiased, best judgment of the treating prescriber.

The proposed rules strengthen and clarify existing limitations for licensees of the Boards of Medical Examiners, Dentistry and Optometry, and extends those standards to Advanced Practice Nurses, the only Board of Nursing licensees with prescribing authority.

In connection with this notice of proposal, the Attorney General will hold a public hearing to take testimony from interested parties to gather facts to inform the proposed rulemaking and to afford ample opportunity for the receipt of public comment from the regulated communities, industry representatives, and the public at large.

The public hearing will be held on Thursday, October 19, 2017.