House passes 'right-to-try' bill on 2nd vote: 10 things to know

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The House of Representatives passed President Donald Trump's "right-to-try" bill March 21, which would allow terminally ill patients to seek drugs undergoing clinical trials and not yet fully approved by the Food and Drug Administration, after the bill failed to pass March 13, according to The New York Times.

Here are 10 things to know.

1. The measure was approved by a vote of 267 to 149. Since the Senate approved a similar proposal last year, the measure may have a good chance of becoming law, according to The Times.

2. Supporters said the bill would give terminally ill patients a chance to try prescription drugs that could potentially help their condition without waiting for clinical trials to be completed or going through FDA processes.

3. A patient must have some kind of terminal illness to qualify under the House bill, which means a condition that is likely to cause death "within a matter of months" or "irreversible morbidity that is likely to lead to severely premature death."

4. The bill would not require pharmaceutical companies to provide experimental drugs to patients who requested them. Drug manufacturers often reject requests due to limited supply or concerns about legal and medical risks.

5. To address these concerns, the legislation would protect drugmakers, physicians and hospitals from a number of the legal risks associated with giving patients unapproved drugs. The bill ensures physicians and hospitals would generally be protected unless they engaged in gross negligence or willful, reckless or criminal misconduct.

6. Republican supporters of the bill said the "right-to-try" law would allow patients to have more control over their care. "I'm a physician and scientist with over 40 years' experience treating patients, some of whom had the dreaded diagnosis of cancer," said Rep. Phil Roe, MD, R-Tenn. "Six months ago, I was operated on for cancer, and I — to this day — am a cancer survivor. If needed, I would like to have the right to try."

7. Democrats who opposed the bill said it would weaken the FDA's ability to protect patients from harmful treatments. "If you eliminate FDA review, as this bill does, you are putting patients at risk," said Rep. Frank Pallone Jr., D-N.J. "This is an unprecedented attempt to roll back FDA's oversight of investigational treatments."

8. A number of organizations representing patients, including the American Cancer Society, opposed the bill. The National Organization for Rare Disorders, which represents patients with rare diseases, said the bill could produce false hopes and "undermine patient safety standards" without increasing patient access to lifesaving treatments.

9. Several former FDA commissioners said the bill was not necessary since patients with a terminal disease or condition could already access experimental medicines through the expanded access program.

10. Under this program, the FDA says it approves 99 percent of the requests it receives. However, in some cases, the agency recommends changes to protect patients before the treatment can proceed.

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