Cortez Masto: No to possible FDA nominee

WASHINGTON — Sen. Catherine Cortez Masto said Thursday she is prepared to lead opposition to a nominee to head the Food and Drug Administration over her role in approving addictive painkillers that led to an opioid epidemic in Nevada and

other states.

President Joe Biden tapped Janet Woodcock as acting commissioner of the FDA in January, following her work over the past year to develop COVID-19 vaccines in record time during the pandemic. She is seen as a potential commissioner nominee.

But her role as head of the agency’s Center for Drug Evaluation and Research nearly a decade ago, as well as decisions to allow sales of addictive medicines, have prompted lawmakers from states suffering from the epidemic to voice their opposition.

“We cannot have an FDA administrator who oversaw the approval of dangerous drugs without sufficient consideration of the role they play in the ongoing addiction crisis in Nevada and across the country,” Cortez Masto said in a statement to the Review-journal.

“I am very concerned about Janet Woodcock’s record,” said Cortez Masto, D-nev.

Biden has not settled publicly on a nominee. A White House official, speaking on background, said that “in the midst of a pandemic, the choice of FDA commissioner is critically important.”

“We take seriously our obligation to find a candidate with strong technical, management, and communications experience,” the White House official told the Review-journal. “In the meantime, we are grateful to have strong career leadership in place.”

Fighting addictive drugs

As Nevada attorney general,

Cortez Masto signed on to a 2013 letter with colleagues from other states urging the FDA to reconsider approval of Zohydro ER, a drug that was reportedly 10 times stronger than hydrocodone products.

The letter said the drug’s approval came without clear guidance on how it should be prescribed, and that it could be over-prescribed by doctors and abused by patients, resulting in addiction and death.

In that 2013 letter, Cortez Masto said “I am concerned that without any deterrent properties Nevada may have more instances of prescription drug abuse.”

Cortez Masto is urging the president to nominate another candidate to head the FDA.

“I’m prepared to work with my colleagues to ensure the next director is a candidate who will prioritize the health and safety of Nevadans, rather than simply rubber stamping drugs without concern for their far-reaching effects,’’ Cortez Masto said.

The Nevada senator is not alone in voicing concern over the potential nomination of Woodcook.

Sen. Joe Manchin, a Democrat from West Virginia, also is concerned because of the FDA’S role in allowing Oxycontin sales and overprescription 30 years ago. Appalachia is considered ground zero for the prescription narcotics epidemic.

In addition, Sen. Maggie Hassan,

Sen. Catherine Cortez Masto, D-nev., speaks in January. Cortez Masto opposes a possible nominee to lead the Food and Drug Administration, which would mark her first break with the Biden administration.

D-N.H., and Sen. Ed Markey, D-mass., have urged the administration to select someone else.

“The FDA has played a critical role in this overdose epidemic overseeing the approval of prescription opioids through its Center for Drug Evaluation and Research,” the senators said in a letter to the president and released by Manchin.

Since 1999, more than 450,000 Americans have died from opioid overdoses, Manchin noted.

Thin majority

With a 50-50 Senate, Biden cannot afford to lose Democratic votes for nominees without picking up equal support from GOP senators to get confirmation.

The break with Biden, should he nominate Woodcock, would be the first for Cortez Masto, who has supported his Cabinet selections and backed the $1.9 trillion coronavirus rescue package.

And while the Democratic opposition headed by Cortez Masto is a hurdle, Woodcock enjoys bipartisan support for accomplishments with Operation Warp Speed under the Trump administration and cancer research.

Six former FDA commissioners sent a letter to the president in early March endorsing Woodcock for the top spot in the agency, citing her experience and leadership, including during the pandemic.

“Dr. Woodcock is a highly effective advocate for advancing the FDA’S mission — a role she has continued from her first day as acting commissioner,” the letter reads.

She also accelerated cancer research, a feat applauded by advocacy groups and nonprofits.

She joined the FDA in 1984 and served in various roles at the agency before being tapped by Biden in January to serve as acting commissioner when Stephen Hahn, an appointee of President Donald Trump, stepped down.

Former FDA official Dr. Joshua Sharfstein, who now works at Johns Hopkins University in Maryland, and Dr. Amy Abernethy, a principal FDA commissioner, have also been mentioned in trade publications as possible candidates for the commissioner position.