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Capitol Checkup: Gottlieb's right-to-try tactic; flu deaths soar; drug czar pick


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Capitol Checkup: Gottlieb's right-to-try tactic; flu deaths soar; drug czar pick

Food and Drug Administration Commissioner Scott Gottlieb signaled in a series of tweets he may be more willing to broaden the access to experimental drugs for critically ill patients beyond the agency's current compassionate use process — a movement known as right to try.

It is not clear, however, whether Gottlieb intends to ultimately back right-to-try legislation or whether his plan is to try to convince Congress that he has sufficient authority to make any necessary changes and to leave the matter in his hands.

In a Feb. 11 tweet, Gottlieb said the FDA would be "announcing some new steps in [the] coming months as we make sure our programs work to help patients who face terminal disease get access to promising options."

The FDA already has a long-running compassionate use program in place in which regulators help terminally ill patients obtain and use investigational medicines outside of the clinical trial process.

Gottlieb noted his agency has taken some steps to try to improve its expanded access program.

But Sen. Ron Johnson, whose right-to-try legislation was adopted by the Senate in August 2017, and other lawmakers have insisted the FDA's current program is too restrictive.

The legislation would protect manufacturers from liability if a patient is harmed or dies from the unapproved treatment. It does not, however, force drugmakers to provide their experimental treatments, so that option would remain with the companies.

President Donald Trump and Vice President Mike Pence have both publicly backed the right-to-try legislation, demanding that the House finish up its work on the bill and get it to the White House for enactment.

Republican Congressmen Andy Biggs of Arizona and Brian Fitzpatrick of Pennsylvania last week urged Speaker Paul Ryan, R-Wis., to bring Johnson's bill to the House floor for a vote as soon as possible.

During a Feb. 1 Republican retreat, Trump insisted that Gottlieb was heading up his administration's right-to-try efforts.

Gottlieb had previously expressed his opposition to Johnson's right-to-try legislation, declaring at an October 2017 hearing it contained flawed criteria, which he said could expose more people unnecessarily to potentially dangerous side effects.

Last week, however, Gottlieb told reporters he thought the FDA would be able to find some sort of a solution with Congress.

In a Feb. 11 tweet, Gottlieb said the "FDA shares the administration's goal to help patients facing terminal diagnosis access promising treatments in their fight."

"Right-to-try policies rooted in strong desire to help patients facing terminal illnesses access experimental therapies with hope these treatments will help," the FDA commissioner tweeted.

He said the FDA was "committed to working closely [with] Congress to advance right-to-try legislation that gives terminal patients [a] chance to access promising treatments as part of our commitment to promote public health options."

"We're working closely with legislators, providing technical assistance," Gottlieb added.

He said that during his tenure as FDA commissioner, he has been working closely with stakeholders to advance opportunities to ensure options for patients diagnosed with terminal illness.

"We remain committed to safely and effectively advancing these programs, and at the same time giving those facing a terminal illness today a chance to access these opportunities," Gottlieb added.

The right-to-try efforts in Congress could be a test of Gottlieb's loyalty to Trump on how far the FDA chief is willing to bow to his boss or it could demonstrate the commissioner's powers of persuasion at the White House and on Capitol Hill to leave the matter to the agency to continue to work out with the biopharmaceutical industry.

US flu hits pandemic-like levels

Influenza and pneumonia are responsible for about one of every 10 deaths being reported in the U.S., according to the head of the Centers for Disease Control and Prevention, or CDC.

To put that into perspective, of the 40,400 people in the U.S. who died during the week ending Jan. 20, about 4,040 of those Americans succumbed to influenza or pneumonia, much of which was related to flu, according to the CDC's National Center for Health Statistics data.

Levels of influenza-like illness across the U.S. are now as high as the CDC observed at the peak of the 2009 H1N1 pandemic, Anne Schuchat, acting director of the agency, told reporters Feb. 9.

She emphasized, however, that does not mean the U.S. is experiencing a pandemic.

"That's a signal of how very intense this flu season has been," Schuchat said.

Overall hospitalizations related to the flu, which already had hit a record high a week earlier, are now even significantly higher, she said.

Schuchat also reported that 10 more children had died of the flu, bringing the total of pediatric influenza-related deaths in the U.S. to 63.

She said the U.S. could be facing several more weeks of flu activity.

The CDC's flu trackers also reported an increase in the B flu viruses circulating in the U.S., especially in western states, as well as a smaller increase in the proportion of cases of the H1N1 strain.

"Last week, B strains made up 30% of the tested viruses," Schuchat said.

She also emphasized that after recovering from one flu virus, some people have been hit with a second or even a third strain, while other Americans have gotten two strains of influenza at the same time.

Although there have been spot shortages of antivirals, like Roche Holding AG's Tamiflu, "manufacturers say there is product available," Schuchat said.

Trump picks new drug czar candidate

The White House revealed Feb. 9 that James Carroll, who has been serving as Trump's deputy chief of staff for the past three months, is the president's new candidate to lead the Office of National Drug Control Policy, or ONDCP, which has gone without a permanent chief for more than a year.

He is expected to serve as deputy director and acting director of the ONDCP while awaiting Senate confirmation, the White House stated.

Carroll, a lawyer who graduated from the George Mason University School of Law, has no background in drug control policy, but White House Press Secretary Sarah Sanders said in an emailed statement the administration has "full confidence" in him to lead the ONDCP.

Before joining the Trump administration, Carroll served as Washington counsel at the Ford Motor Co., where he worked for a number of years.

He held various legal positions during the George W. Bush administration.

Trump's first ONDCP nominee, Rep. Tom Marino, R-Pa., withdrew his name from consideration in October 2017 after he came under fire for pushing a bill through Congress that ultimately weakened the Drug Enforcement Administration's ability to rein in distributors selling opioids to rogue pharmacies.

Taylor Weyeneth, a former campaign staffer who was appointed deputy chief of staff at the ONDCP, had been running the office in an acting capacity. But Weyeneth resigned late last month after his inexperience and young age became a lightning rod for critics.

Trump also has been criticized for wanting to cut the ONDCP's budget, possibly by as much as 95%.

Even with Carroll's appointment, Kellyanne Conway, a senior adviser to Trump, appears to still be in charge of the White House's efforts to address the opioid epidemic, despite her lack of experience and background in drug policy.

During a Feb. 11 appearance on CNN's "State of the Union," Conway said Trump plans to use the $6 billion in opioid crisis funds Congress authorized last week on treatment and recovery, interdiction and law enforcement and education and prevention, "because we need to tackle all three at once."

It is not yet clear how much of those funds will be directed to the National Institutes of Health, or NIH, which has been waiting for financial support since May 2017 to get a public-private partnership off the ground aimed at accelerating the development of nonaddictive alternatives to opioids and better overdose-reversal agents.

Sens. Lamar Alexander, R-Tenn., Patty Murray, D-Wash., Todd Young, R-Ind., and Maggie Hassan, D-N.H., introduced legislation last week aimed at giving the NIH more flexibility to conduct research to address the opioid epidemic.

Alexander said the Senate Health, Education, Labor and Pensions Committee, which he leads, plans to consider the bill before the end of March.