Gottlieb: Agency will adequately protect patients following passage of 'right to try'

FDA Commissioner Scott Gottlieb addressed the passage of right-to-try legislation during The Atlantic's The State of Care: Patient Access & Affordability event held at the Newseum on Wednesday. (The Atlantic)

Food and Drug Administration Commissioner Scott Gottlieb, M.D., said Wednesday that his agency would ensure that patients are "adequately protected" under the right-to-try measure that passed the U.S. House on Tuesday. The legislation would allow patients with terminal diseases or conditions to try investigational therapies that have not yet been approved by the FDA.

The bill, which originally passed the Senate last August, now heads to President Donald Trump for his signature.

Trump has spoken in strong support of right-to-try laws and is expected to sign the measure. But it has faced concern among former FDA commissioners who worry the law would undermine the agency's efforts to ensure safety.


13th Partnering with ACOS & IDNS Summit

This two-day summit taking place on June 10–11, 2019, offers a unique opportunity to have invaluable face-to-face time with key executives from various ACOs and IDNs from the entire nation – totaling over 3.5 million patients served in 2018. Exclusively at this summit, attendees are provided with inside information and data from case studies on how to structure an ACO/IDN pitch, allowing them to gain the tools to position their organization as a “strategic partner” to ACOs and IDNs, rather than a merely a “vendor.”

"We're committed to the underlying goals here of trying to get promising products to patients who are out of options," said Gottlieb, speaking at The Atlantic's The State of Care: Patient Access & Affordability event in D.C.

He pointed to the FDA's investment in its expanded access program, which allows for "compassionate use" of a drug candidate that has not been approved by the FDA.  He also said the agency provided technical assistance to lawmakers—in particular, Energy and Commerce Committee Chairman Greg Walden,R-Ore., on the bill to ensure patient safety issues were addressed.

RELATED: Gottlieb: FDA to kick-start plans to increase competition in drug markets this week

"I think some of those things we can address through the implementation process while making sure we stay still staying true to the letter of the law," Gottlieb said. I think there are things we can do to make sure patients are adequately protected under this legislation while we make sure the goals are achieved."

The passage was quickly praised by Republicans, as well as the president, on Tuesday. 

“Today’s vote is a beacon of hope for the patients who are desperately seeking the ‘right to try’ investigational treatments and therapies," said Walden and Health Subcommittee Chairman Michael C. Burgess, M.D., R-Texas, in a joint statement.

RELATED: FDA’s Scott Gottlieb wants to use funding boost to create a Center of Excellence on Digital Health

Also during the discussion, Atlantic's Washington Editor-at-Large Steve Clemons asked Gottlieb to address how he seems to get along with so many people—including Democrats and the president—in such a polarized political climate.

"What do you think you're getting right?" Clemons asked. "I think it'd be a good lesson for people trying to operate in this weird town right now." 

Gottlieb said he'd learned a number of lessons during his career working for three different FDA commissioners.

"It's very important to leverage the expertise at FDA. I can come out with broad outlines of what sort of goals I want to accomplish thematically, but the ideas need to come from the professional staff in the organization," he said. "We've practiced that and I think that's why we've been able to come up with a lot of new initiatives and put things out quickly and aggressively."

He also said it's important to prioritize and seize opportunities.

"You've got much less time in these jobs than you think you're going to have. And so the best time you have to do something is yesterday," he said.

Suggested Articles

The Trump administration has released its annual rule governing payments to inpatient providers.

Pharmacy retail giant Walgreens plans to implement a new minimum age requirement of 21 for its customers seeking to purchase tobacco products in its stores.

An artificial intelligence tool can help diagnose post-traumatic stress disorder in veterans by analyzing their voices, a new study found.