The House is scheduled to vote next week on a "right-to-try" bill, which would allow terminally ill patients to take drugs undergoing clinical trials and that have not been fully approved by the FDA. But FDA Commissioner Scott Gottlieb, MD, said if the bill passes, the agency would have to work harder to protect patients than it would under alternative legislation, he told STAT.
Here are seven things to know.
1. In comments made at the FDA headquarters May 17, Dr. Gottlieb indicated one of President Donald Trump's lieutenants thinks Congress is going forward with a bill that takes less FDA input into account than an alternative version of the bill. The alternative version of the bill passed the House in March but stalled in the Senate, according to a separate STAT report.
2. Dr. Gottlieb said the FDA will have to work harder to protect patients than it would have had to under the structure of the alternative bill, led in part by Rep. Greg Walden, R-Ore.
3. The bill the House is set to vote on next week comes from Sen. Ron Johnson, R-Wis. This bill does not include as much of the FDA's input and could give more patients the opportunity to seek experimental treatments.
4. "In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections, I think the Walden bill gives us less work to do," Dr. Gottlieb said. "With the Johnson bill, we'd have to do a little bit more … in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve."
5. Dr. Gottlieb said Mr. Walden's bill "baked in more of the technical assistance we provided." But in a subsequent interview the afternoon of May 17, Dr. Gottlieb said he supports the Johnson bill and was unaware the House was set to vote on that bill when he spoke with STAT earlier that day. "We can implement the Johnson bill in a way that achieves what Chairman Walden set out to do," he said.
6. Mr. Walden offered support for the upcoming vote on Mr. Johnson's bill as well as a defense of his bill. "We aimed to build upon Sen. Ron Johnson's hard work, and I am proud of the bill passed by the House in March," he said. "Sadly, Senate Minority Leader Chuck Schumer, D-N.Y., chose to block sick patients from access to investigational drugs. It is time for the House to do what Senate Democrats won't and send a right-to-try bill to the president's desk, bringing hope to terminally ill patients across the country."
7. Supporters of the right-to-try bill argue it can help critically ill patients who feel they cannot wait for the FDA to fully approve potentially life-saving treatments. Opponents claim the bill will weaken FDA oversight on approving drugs and endanger patients vulnerable to the consequences of experimental treatments.