Trump signs "Right to Try" law making investigational drugs legal
Today Pres. Trump signed into law the "Right to Try Act of 2017," which gives hope to millions of terminally ill Americans. The decision could be lief-saving as it "authorizes certain patients to seek access to certain unapproved investigational
drugs directly from a drug sponsor or manufacturer; limiting the use of clinical outcomes and liability arising from the provision of such drugs; and provides reporting requirements for the use and outcomes of the new authority." In the past known, traditional drugs were a last resort. Following is a sammary of The Act:
PRESIDENT DONALD J. TRUMP TO SIGN RIGHT TO TRY LEGISLATION FULFILLING THE PROMISE HE MADE TO EXPAND HEALTHCARE OPTIONS FOR TERMINAL AMERICANS
“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
RIGHT TO TRY: Congress passed the Right to Try Act of 2017, sending a priority bill to President Donald J. Trump for his signature.
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The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Belllina Right to Try Act of 2017” passed Congress on May 22, 2018.
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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.
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Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.
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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.
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The FDA will post an annual summary report of “Right to Try” use on its website.
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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.
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“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.
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According to the National Cancer Institute, an estimated 609,640 Americans will die from cancer alone in 2018.
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Prior to this legislation, options for terminally patients who had exhausted all treatment options were extremely limited:
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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.
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The FDA’s “compassionate use” application is complicated and time-consuming, resulting in only about 1,200 approved applications per year.
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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.
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On May 11, 2018, the President issued his blueprint to lower prescription drug prices, taking action to put American patients first.
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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.
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In March 2018, President Trump’s Administration released the President’s plan to put patients back in charge of their own health information.
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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.
SOURCE: White House
