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Pink Sheet – Woodcock Has Big, Quiet Supporter In Her Bid For US FDA Commissioner

Pink Sheet – Woodcock Has Big, Quiet Supporter In Her Bid For US FDA Commissioner

Executive Summary

Industry groups, along with many rare disease and patient advocacy groups, appear behind the acting commissioner getting the permanent position.

Supporters of Janet Woodcock’s bid to become commissioner of the US Food and Drug Administration are emerging, although one of the biggest is choosing to stay in the background.

Dozens of rare disease and other patient organizations have penned letters supporting Woodcock, who currently is the acting FDA commissioner. And Friends of Cancer Research Chair and Founder Ellen Sigal was one of the co-authors of an op-ed in the LA Times calling for Woodcock to be nominated over Joshua Sharfstein, the other rumored contender for the position.

But Woodcock also apparently has the pharma industry trade associations on her side as well. They are “quietly” supporting Woodcock, because using its large megaphone could be counterproductive with a Democratic administration, sources told the Pink Sheet.

Biotechnology Innovation Organization Executive VP for Public Affairs Rich Masters said the organization typically does not support or oppose potential nominees, but also said that “BIO has always had productive working relationships with FDA and its leaders, including Dr. Woodcock, and we expect that to continue in the months and years ahead.”

The Pharmaceutical Research and Manufacturers of America said a commissioner with experience will be important.

“For the agency to continue providing critical science-based regulatory oversight of our nation’s medicine supply, we believe it is vital for an experienced permanent commissioner be named in a timely manner,” the trade group said in a statement.

The brand industry’s influence on Capitol Hill is substantial. While President Biden will not accept pharma’s choice for that reason alone, pharma support will go a long way in ensuring confirmation.

Indeed, the industry’s perceived close relationship with Woodcock, who prior to becoming acting commissioner was director of the Center for Drug Evaluation and Research for decades, is among the primary complaints of her opponents.

Several opioid groups, as well as Public Citizen, oppose Woodcock becoming commissioner in part because in their view she sides with industry more than public health goals. They view Sharfstein, a former principal deputy FDA commissioner and now vice dean for public health practice and community engagement at Johns Hopkins University, as leaning more towards their public health priorities. (Also see “Campaign Against Woodcock’s US FDA Commissioner Bid Has Begun” – Pink Sheet, 28 Jan, 2021.)

Woodcock has embraced agency flexibility with its product approval standards, especially for rare disease treatments, often drawing criticism. Her decision to overrule the assessment staff and grant accelerated approval to Sarepta Therapeutics, Inc.’s Duchenne muscular dystrophy treatment Exondys 51 (eteplirsen) is often raised as a prime example of her industry-friendly views. (Also see “Sarepta’s Eteplirsen Approved After Contentious Internal FDA Debate” – Pink Sheet, 19 Sep, 2016.)

Sigal Urges Biden To Nominate Someone Soon

Sigal and op-ed co-authors Sherry Lansing, founder and CEO of The Sherry Lansing Foundation, and Phillip Sharp, Institute Professor at the Massachusetts Institute of Technology and chair of the Stand Up to Cancer scientific advisory committee, wrote that they “have seen firsthand the leadership shown by Janet Woodcock … in making breakthroughs a reality for patients.”

They also said the next commissioner “will have to take on the immense challenge of repairing what four years of disregard for science have done,” as well as ensure new advancements in cancer and other diseases are not endangered by the pandemic.

Sigal, Lansing and Sharp argued that “no individual is better positioned to navigate the pandemic and take the agency forward” than Woodcock. “Woodcock’s qualifications at this vital moment are unimpeachable,” they wrote.

“She has always been straightforward in her belief in science, innovation and the important role FDA plays in the lives of patients.”

The three also urged President Biden to announce the commissioner nomination soon. 

“The absence of a nominee to head the FDA risks impeding the assembling of a full-force health team,” they wrote. “We need a leader with the knowledge and experience to hit the ground running on day one. Woodcock is the best person to fill that role.”

The FDA suffered from credibility and independence questions as the Trump Administration battled the coronavirus pandemic. Trump tried to influence the FDA to move more quickly than it wanted on COVID-19 treatments and vaccines and pushed to make products available even though there was little scientific evidence of efficacy.  (Also see “‘Bruised’ But Not Broken: Ex-Commissioners See FDA Intact Amid Transition” – Pink Sheet, 10 Dec, 2020.)

Rare Disease And Other Patient Groups Get Behind Woodcock

Eighty-two members of the EveryLife Foundation Patient Organization Community Congress signed a letter to Biden supporting Woodcock’s appointment as acting commissioner and suggesting she is qualified for the permanent position.

The groups wrote that “Woodcock has innovated a paradigm shift in therapeutic development, infrastructure, and stakeholder engagement within the ecosystem that has yielded robust development pipelines in disease areas with significant unmet need.”

The groups said their most important ask is to continue the growth of the FDA’s patient-focused drug development program, an effort to increase the patient voice in agency decision-making that Woodcock embraces.

“While Dr. Woodcock’s focus remains evidence-based, she understands the critical role of patient representation in evidence collection and product development,” they said in the letter.

The PFDD program was created as part of the prescription drug user free reauthorization in 2012 and began as a series of disease-focused meetings where patients and advocates commented on existing treatments and unmet needs. The program is intended to help FDA staff better gauge product risks and benefits.  (Also see “Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point” – Pink Sheet, 9 Feb, 2020.)

Several other groups led by the Alliance for Aging Research also have signed on to a letter supporting Woodcock, saying her “principles have remained steadfast” through the years, including her commitment “to base decisions in support of FDA’s public health mission on sound science.”

“At the most fundamental level, Dr. Woodcock has demonstrated over nearly four decades that she cares deeply about the agency, its mission, and its people,” they wrote.

Commissioner Decision May Include Several Moving Parts

Biden has not indicated when he could announce an FDA commissioner choice, but the decision could hinge on several factors that have yet to resolve.

One may be the confirmation of a Secretary of Health and Human Services, who likely will have a say since the FDA commissioner will work under them. Nominee Xavier Becerra has yet to receive a confirmation hearing in the Senate.

VP Kamala Harris, as well as new Senate Health, Education, Labor and Pensions Committee Chair Patty Murray, D-WA, and House Energy and Commerce Committee Chair Frank Pallone, D-NJ, who run the congressional committees overseeing the FDA, will also likely have input.

Historically, the FDA commissioner is not among the first nominations to be revealed. President Trump did not announce Scott Gottlieb as his FDA commissioner nominee until March 2017, three months after he took office. (Also see “Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process” – Pink Sheet, 13 Mar, 2017.) President Obama waited a similar amount of time before nominating Margaret Hamburg.  (Also see “Nominations To Lead FDA Coming Soon For Hamburg And Sharfstein” – Pink Sheet, 9 Mar, 2009.)

Confirmation battles can last many weeks. Gottlieb needed 56 days and Hamburg 64 days to navigate the process.  (Also see “A Return Trip For Kessler At US FDA? It Wouldn’t Be The First Time It’s Happened” – Pink Sheet, 2 Dec, 2020.)

The schedule for this nomination also may be complicated by President Trump’s second impeachment trial, which will begin 9 February. The Senate will not be conducting any other business while the trial is ongoing.

Biden’s nominee for CMS administrator also has not been announced, but a list of finalists has emerged.  (Also see “CMS Administrator Search: 3 Obama-Era Officials Being Considered To Lead Biden’s Medicare Agency” – Pink Sheet, 27 Jan, 2021.)…