The House on May 22 approved the "right-to-try" bill, which would allow terminally ill patients to seek drugs undergoing clinical trials and not yet fully approved by the FDA, The Washington Post reports.
Here are eight things to know.
1. The Senate passed the bill in August, and the House approved its own version of the legislation in March that was less objectionable to medical groups. However, that version of the bill did not proceed. To speed the process, House leaders chose to take up the Senate-passed bill. The vote was 250-169.
2. This version of the bill, led by Sen. Ron Johnson, R-Wis., would give patients the opportunity to seek out drugs that have not been FDA-approved. As it stands, patients can only seek experimental treatments by participating in clinical trials or enrolling in the FDA's "expanded access" program. The FDA has said it approves nearly all requests to the expanded access program.
3. Under this legislation, the FDA would not oversee the right-to-try process. Drug manufacturers would be required to report adverse events once a year. The FDA would also be limited in how it could use this information when deciding whether to approve experimental treatments.
4. Patients eligible for right-to-try include those with a "life-threatening illness" who have exhausted all available treatments. The medication would be required to have completed early stage safety testing, called phase 1 trials, and be in active development aimed at receiving FDA approval.
5. President Donald Trump is expected to quickly sign the measure, the Post reported. The White House issued a statement May 21, saying the Trump administration "believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians."
6. FDA Commissioner Scott Gottlieb, MD, expressed concern about the bill, saying if it passes, the FDA would have to work harder to protect patients than it would under alternative legislation, and it could undermine the agency's authority.
7. During the House debate, Rep. Frank Pallone Jr., D-N.J., said getting rid of FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients."
8. Supporters of the legislation argue it can help critically ill patients who feel they cannot wait for the FDA to fully approve potentially life-saving treatments. After the House vote, Victor Riches, president and CEO of the Goldwater Institute, said "Millions of Americans who have been told they are out of options and it's time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first."