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HITE OAK, Md. — The House is set to take up a controversial “right-to-try” bill next week — and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT in an interview.

Gottlieb’s comments, made at FDA headquarters on Thursday, indicate that one of President Trump’s top lieutenants believes Congress is moving forward with a bill that contains less of his agency’s input than an alternative version of the bill — a more recent, updated bill that passed the House in March but ultimately stalled in the Senate.

Broadly, right-to-try legislation aims to give terminally ill patients a different pathway to access experimental treatments that are not FDA approved.

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Gottlieb said his agency will have to work harder to protect patients than it would have had to under the structure set up in the alternative bill, which was spearheaded in large part by Energy and Commerce Committee Chairman Greg Walden of Oregon. The bill the House will vote on next week, from Sen. Ron Johnson (R-Wis.), didn’t include as much of the FDA’s input and could open the pathway to more patients.

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“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.”

He said the newer Walden bill “baked in more of the technical assistance we provided.”

In a subsequent interview Thursday afternoon, Gottlieb added that he is supportive of the Johnson bill, and said he had not realized the House was set to vote on that bill when he spoke with STAT earlier in the day.

“We can implement the Johnson bill in a way that achieves what Chairman Walden set out to do,” Gottlieb said.

“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.

In his own careful statement, Walden managed to simultaneously offer support for the looming vote and a defense of his bill, which would be forgotten if next week’s vote is successful.

“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.”

The announcement that legislative efforts are back on track is something of a win for Koch-backed groups like Americans for Prosperity, which had been urging Congress to move quickly, including in a series of ads this spring.

Supporters of the right-to-try movement say it empowers patients who feel they don’t have time to wait for an overly cumbersome FDA process and set of rules.

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.

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  • 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.

  • The FDA has some bad hombres working there who are protecting the HIV drug gravy train they have been harming society keeping the mist tested HIV vaccine Remune the Salk vaccine off the Market and a small biotech Immune Response Biopharna the commissioner works more on dying his jet black Elvis hair then helping bring Remune to market.

  • One of the reasons that Right to Try got started was that the FDA required physicians to spend an average of 100 hours filling out paperwork for a compassionate use exemption for their patients, which most doctors wouldn’t do. Even when they did, many of the applications weren’t approved until it was too late for the patients. That’s how the Abigail Alliance (http://abigail-alliance.org/), which sued the FDA on behalf of terminally ill cancer patients, got started. When Right to Try got to Congress, the FDA finally simplified the paperwork somewhat. I’d like to see STAT include “the other side of the story” when they report that the FDA approves 99% of the applications.

    • Mary,
      With all due respect that is nonesense the applications aren’t submitted because the pharma doesn’t want to provide the drug, the paperwork was onerous, 99% of a small amount is fake. No HIV vaccine access to Remune for patients you live in a bubble while the govt protects it’s piece if the drug pie keeping patients hooked on HIV drugs is profitiable for even the govt. Cancer isn’t the only access problem, it’s a liability issue, and no incentive to provide the drugs to patients outside of the clinical trial process. You don’t know what you are talking about period.

  • The government has no right to get involved in our very personal healthcare decisions. They are in fact the proven worse group to be involved in anything that has to do with healthcare as has been proven by the current idiots in congress.

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