You’ve been handed down a death sentence from your doctor. You’re dying. How far would you go to save your own life? What would you be willing to do if it meant expanding your time here on Earth? What if you’d tried every treatment and drug available and had zero results? You’d done your research and found a drug or drugs that were in the process of being approved by the FDA that could potentially lengthen your lifespan–or at the very least improve your quality of life for the remainder of the time you’ve been given? There’s a catch though. In order to test these drugs you will have to wait until they’re fully approved which could take upwards of ten to fifteen years, years that you may not have.
Patients who have been given a short time to live shouldn’t have to wait years for the FDA to run their trials before the patients are able to gain access to drugs that could potentially add years to their lives. With hope already dwindling away, finding out that certain drugs could potentially extend the patient’s life are out of their reach entirely, is just another hope lost.
The Right to Try bill signed Wednesday by President Donald J. Trump will help terminally ill patients gain access to drug treatments that remain in clinical trials and have passed Phase 1 of the Food and Drug Administration’s approval process, but are yet to be fully approved by the FDA. The passing of this bill into law means that patients who have been diagnosed with a terminal condition will no longer have to wait years for access to potentially life saving medications to be tested by the FDA or to become commercially available.
“As I proudly sign this bill, thousands of terminally ill Americans will have the help, the hope and the fighting chance–and I think it’s going to be better than chance–that they will be cured, that they will be helped, that they will be able to be with their families for a long time, or maybe just for a longer time, “Trump said. “But we’re able to give them the absolute best we have at this current moment, at this current second. We’re going to help a lot of people. It’s an honor to be signing this.”
The Right to Try Act of 2017 was sponsored by Sen. Ron Johnson, R-Wis., passed in the Senate last August and cleared the House last week on a party-line vote of 250-169. A YUGE WIN for all involved in the passing of the bill as well as the patients it will serve.
“I would not be here today without the tireless efforts of dedicated members of Congress,” President Trump said, specifically pointing out Rep. Brian Fitzpatrick, R-Pennsylvania, Sen. Ron Johnson R-Wisconsin, Rep. Michael Burgess, R-Texas, and Sen. Joe Donnelly, D-Indiana.
This was originally brought up in January during Trump’s State of the Union Address pressing Congress to focus attention on the issue-Wednesday the president signed it into law. During this State of the Union Address the president addressed the need for the bill, “Patients with terminal conditions should have access to experimental treatments that could potentially save their lives,” he continued “It is time for the Congress to give these wonderful Americans the “right to try.”
Although state legislation differs from the bill signed into law today, the Goldwater Institute (libertarian-leaning) has used the broad popularity of the policy to help achieve passage of similar legislation in 38 states.
Drug companies will seldom do anything that would raise their risk of failure–especially risking one of the patients dying that might be taking their drug for treatment. If this were to happen, it would be counted against the company who was seeking approval of said drug. Unless a terminally ill patient qualifies for one of the limited spots available for clinical trials, they are not able to access the drug during the testing process.
It takes on average $1.4 billion to get a product approved by the FDA. Before a drug company can sell their first dose, they will pay upwards of $5 billion to bring their new treatment drugs to market. Failure at any stage of testing these drugs means that the product is scrapped and all further testing immediately ceases.
Compassionate use is a program of the FDA formally known as expanded access and is meant as a way to treat dying patients with medications that are still being tested in clinical trials and otherwise not available to the general public. In order for a patient to be approved for compassionate use there must be a request from the patient’s doctor, it must be endorsed by the company that makes the drug, as well as be approved by officials at the FDA.
Drug developers do not get any direct benefit from compassionate use, are rarely paid for making their products available, and do not receive any government funding. If there is a negative outcome, investors will question the drug’s value and abandon the company’s stock which would leave it with no other way to raise the money needed to continue testing. According to clinicaltrials.gov, the number of ongoing clinical trials that are open to compassionate use is less than 1 percent.
Another problem that those who are terminally ill run into is that drug makers cannot be forced to make their products available for compassionate use. Participating in compassionate use is risky business for the drug companies and uncommon, especially during trials. Negative outcomes from drugs in compassionate use cases can delay or in some cases even derail clinical trials, determining whether the company itself will survive. Adverse effects, especially those resulting in the death of a patient who’s already dying MUST be reported by the drug company and the FDA if it occurs in any compassionate use case, halting clinical trials and also may result in requirement of the drug manufacturer to post warnings on the product’s labels if it’s approved.
What does the bill change? Essentially, it will remove all application requirements of the FDA’s access program and save patients invaluable time. It also removes any government interference and liabilities against the companies that produce the drugs, manufacture, prescribe, dispense, possess, or patients themselves who take the drugs. The bill H.R.878, goes on to break down what each individual term means in detail and can be read in its entirety here:
The president said he was seeking the “better bill” for “the people”. “Not the pharmaceutical companies, not the insurance companies–I don’t care about them. I really couldn’t care less,“Trump said, with emphasis on the importance of a bill for “the people”. The Right to Try bill gives life-saving hope back to those who’ve lost it.
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