Right-to-try bill headed for vote puts bigger burden on fda, gottlieb says electricity billy elliot lyrics


“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,” 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.”

“We felt that there were certain aspects of the [Johnson] legislation that could be modified to build in additional patient protections, but if you weren’t able to do that legislatively, that [there] was a pathway by which you do that administratively and still remain consistent with both the letter and the spirit of this law,” he added.

Right-to-try legislation, long a priority of Vice President Mike Pence’s, has increasingly become a priority for Trump. He opened a Rose Garden speech last Friday with a nod to Gottlieb’s efforts to bring the legislation to fruition, and he mentioned the issue in his State of the Union address this year, too.

A new strategy outlined Thursday by House Majority Leader Kevin McCarthy is a blow to supporters of the House-passed measure, particularly after the FDA provided substantial technical guidance to try to improve Johnson’s Senate-passed bill. Gottlieb even testified on his concerns with the legislation last October, suggesting that the FDA narrow the scope of the bill.

“We aimed to build upon Senator Ron Johnson’s (R-WI) hard work, and I am proud of the bill passed by the House in March,” he said. “Sadly, Senate Minority Leader Chuck Schumer (D-NY) 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.”

Opponents say the effort will weaken the FDA’s oversight of the drug approval process and endanger patients who are vulnerable and prone to “snake oil” salesmen. They point out that the FDA already has a process in place for approving requests for terminally ill patients, and that it does so in about 99 percent of cases, often within a short time frame.

Nas, I do know what I’m talking about; I was involved with some compassionate use deliberations when I worked in the industry. There are some liability issues which are addressed in the Right to Try legislation, but the bigger concerns seem to be supply issues and fear about what will happen if a compassionate use patient dies. The FDA sometimes assumes that the deaths might be due to the drug, not the disease, and then requires additional studies. Such extra time and effort can result in a competitor getting the lucrative first-to-market position in a new class of drugs.

However, my comment specifically addressed the onerous requirements of the FDA’s compassionate use program on doctors who might otherwise try to get an investigational drug for their patients. Even if Right to Try passes, I suspect many companies will hesitate to utilize it for fear that the FDA will be offended and punish them by dragging their feet at various steps of the approval process. However, in states where it has passed, some patients are already benefiting: https://goldwaterinstitute.org/article/texas-doctor-using-right-to-try-law-to-treat-cance/. Some lives will likely be saved by this legislation, even with the type of concerns that both of us have mentioned.