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Op-Ed: The right leader for the FDA in a time of crisis

The U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.
The Food and Drug Administration is currently being led by the acting commissioner, Janet Woodcock. President Biden has not yet announced his permanent pick.
(Associated Press)

President Biden’s commitment to science is lifelong, and he has shown this through many excellent appointments to health-related positions in his administration. However, one of the most important appointments, commissioner of the Food and Drug Administration, has not yet been made.

The FDA is charged with critical review and scientific decisions to protect and ensure public health. This includes the review of COVID-19 vaccines, tests and treatments, as well as life-extending cancer therapies, and the review of medical devices that millions of patients rely on every day.

With COVID-19 having claimed more than 455,000 American lives, a number strikingly similar to the lives lost to cancer each year, the person nominated to lead the FDA will face one of the most perilous and serious public health crises the U.S. has ever seen. The new commissioner will have to take on the immense challenge of repairing what four years of disregard for science have done — while also making sure that new advancements in treating cancer and other maladies are not jeopardized as we battle the pandemic.

As individuals who have spent our lives working to advance science and advocate for cancer research, we and many of our colleagues in the oncology community have seen firsthand the leadership shown by Janet Woodcock, the current acting commissioner of the agency, in making breakthroughs a reality for patients. That is why we believe that no individual is better positioned to navigate the pandemic and take the agency forward than the person leading the FDA right now.

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In order to restore trust in the FDA, and restore morale within, a permanent leader with expansive experience, medical expertise and the confidence of agency staff and the American public needs to be nominated in short order.

Woodcock’s qualifications at this vital moment are unimpeachable. She has always been straightforward in her belief in science, innovation and the important role the FDA plays in the lives of patients.

Having served for decades as the director of the FDA’s Center for Drug Evaluation and Research, she has led the agency as the global gold standard for regulatory science, innovation and protecting public health. In cancer care, the FDA’s approval of immunotherapy is one of the most important advances in decades. It has saved the lives of many cancer patients with melanoma, lung cancer and other types of cancer. Over this period, Woodcock’s leadership has been visionary. The agency’s decisions have protected patients and advanced lifesaving treatments.

Much is at stake with the high-profile role of the FDA’s decisions in the coming months. The absence of a nominee to head the FDA risks impeding the assembling of a full-force health team. 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.

Phillip A. Sharp is a Nobel laureate and institute professor at the Massachusetts Institute of Technology, a member of the department of biology at the Koch Institute for Integrative Cancer Research and chairperson of Stand Up to Cancer’s scientific advisory committee. Ellen V. Sigal is chairperson and founder of Friends of Cancer Research. Sherry Lansing is the founder and chief executive of the Sherry Lansing Foundation.


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