More than half of the countries in the EU have paused AstraZeneca vaccinations amid panic that the shot could cause blood clots — despite lack of evidence.
Over the past several weeks, Sens. Maggie Hassan and Ed Markey have voiced concerns about Woodcock’s work on opioids, an issue that a spokesperson for Hassan said has been relayed directly to Biden officials as well.
Sen. Joe Manchin of West Virginia — a state hard-hit by the addiction epidemic — also privately signaled resistance to a potential Woodcock nomination, according to a person familiar with the Senate discussions. The pushback has prompted fears that several Democrats would come out against Woodcock if Biden nominated her, forcing the administration to rely heavily on Republicans to secure her confirmation.
Among senators in states ravaged by the opioid crisis, Woodcock is “the most culpable bureaucrat that exists,” said the person familiar with the Senate discussions, adding that Hassan, Markey and Manchin have opted to hold off on registering their official opposition until Biden’s pick for health secretary, Xavier Becerra, weighs in on the FDA role. Becerra is expected to be confirmed on Thursday.
Liberal groups have jumped into the fray as well, decrying Woodcock as an industry-friendly regulator amid a broader campaign for Biden to nominate an FDA chief who would put far more distance between the agency and the drugmakers that it oversees.
“We basically have regulatory capture at the agency, which has corrupted and undermined the decisionmaking process,” said Michael Carome, director of the health research group at Public Citizen, who sparred with Woodcock last year over the agency’s support of an Alzheimer’s drug that was near-unanimously rejected by an expert panel. “She’s a bad choice.”
Woodcock also played a central role in the 2016 approval of a muscular dystrophy medicine from Sarepta despite thin data and objections from drug reviewers like Ellis Unger, who filed a formal complaint against her.
Even Woodcock’s broad-based support within the scientific research community has come under scrutiny of late, with critics pointing to the drug industry funding underpinning boosters like the influential Friends of Cancer Research.
“The rallying around Ms. Woodcock’s nomination that we’ve seen from big pharma should give everyone real pause,” Hassan said in an email.
That rush of hostility derailed plans for a speedier decision within the White House, which is now quietly seeking alternate candidates. Joshua Sharfstein, a former top FDA official and Maryland health secretary who is viewed as a more progressive option, is still in contention for the job, two people with knowledge of the process said.
Biden officials have also dispatched allies to sound out potential new candidates. Among them was Eric Topol, a well-known cardiologist and public health expert at the Scripps Translational Research Institute, who told POLITICO he was approached about the job in recent weeks, but turned it down.
“It was a legitimate query, but I very quickly dismissed it,” said Topol. He called Woodcock a “highly competent” leader but argued the administration should bring in a commissioner from outside the agency.
Still, the search has not turned up a new consensus pick, and among some in the White House, Woodcock remains the favored candidate.
Even as officials have solicited suggestions from allies for who else should be considered, they have also asked how they think Woodcock is doing and whether she’d be good for the permanent role, said a person with knowledge of the conversations. And in a March 9 letter to Biden urging him to pick an FDA chief, six former agency heads singled out Woodcock as a “highly effective” advocate for the FDA.
With Becerra in line for confirmation, the White House is expected to soon accelerate efforts to land on a final nominee.
In the meantime, the administration has been inundated by widespread support for Woodcock from a range of nonprofits, medical advocacy groups and researchers that have long supported Biden — some of whom have grown increasingly dismayed by the White House’s indecision.
Several allies of Woodcock have privately vented that the opioid-related opposition — which they dismissed an unfair effort to scapegoat her — never would have emerged as a concern if the administration had moved faster on her nomination.
And they have questioned whether the White House has any real hope of finding someone more prepared to do the job amid crisis conditions, especially after nearly a half-year of effort between Biden’s transition team and his administration and as the agency sits in limbo.
Those are urgent concerns that have lately reached the Oval Office. After a group of lawmakers met with Biden earlier this month on cancer issues, Rep. Anna Eshoo — a senior Democrat on the Energy and Commerce Committee — buttonholed the president over his vacancy at the FDA.
“I said, you have an individual at the FDA whose biggest achievement has been the acceleration of cancer research and products that have made it to the market, and that’s Dr. Woodcock,” Eshoo, a longtime medical research advocate who counts the drug industry among her top donors, recounted in an interview. “I think that the American people would be so well served by her.”
Sarah Owermohle contributed to this report.