On Jan. 20, the Biden administration named Dr. Janet Woodcock acting commissioner of the U.S. Food and Drug Administration (FDA).

As The New York Times reported over the weekend, Woodcock is “one of two leading contenders” to lead the agency, but she faces “strong opposition.”

Among those opposing Woodcock’s appointment as FDA commissioner is as  a coalition of nonprofit advocacy groups who argue that Woodcock’s “inadequate” oversight of the FDA during the opioid crisis should disqualify her. In a letter to officials at the Department of Health and Human Services, the coalition wrote:

“In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis.”

Woodcock previously was director of the FDA’s Center for Drug Evaluation and Research (CDER) where she played a key role in the approval of opioids, including for children ages 11 – 16.

Woodcock’s tenure with the FDA coincided with that of Dr. David Kessler, former FDA commissioner. Kessler was featured in a February 2019 segment on CBS 60 Minutes where he admitted that Purdue Pharma’s opioid, OxyContin was not originally approved for long-term chronic pain use.

60 Minutes obtained a court order for documents which revealed secret meetings between the FDA and Purdue Pharma after which the FDA bowed to the drugmaker by choosing to ignore the lack of scientific data, and allowing the OxyContin label to read “around the clock … for an extended period of time.”

According to 60 Minutes, one internal document revealed that Purdue Pharma was jubilant about the labeling change, saying “The action by the FDA … has created enormous opportunities” to expand the market. Purdue’s sales tripled.

Kessler also told 60 Minutes the label change was a blank check — one the drug industry cashed in for billions and billions of dollars. The label change gave Big Pharma the green light to push opioids to tens of millions of new pain patients nationwide.

Woodcock defended the FDA’s opioid approval process, stating that “although higher total daily dosages were associated with fatal outcomes, it cannot be concluded that the higher total daily dosages are causally associated with fatalities given the other variables have not been measured … there is no maximum dose for opioids.”

When OxyContin was approved for children 11 – 16 — under Woodcock’s watch — the FDA’s own advisory committee was not consulted:

As acting commissioner, Woodcock is now focusing on vaccines for COVID-19, but past conflicts of interest raise questions about her suitability for that role.

The questions date back to April 2009, when Amphastar Pharmaceuticals filed a complaint with the FDA alleging that Woodcock and one of Amphastar’s competitors, Momenta Pharmaceuticals, had an improper relationship, which resulted in Woodcock favoring Momenta.

At the time, both companies were seeking approval for the generic version of  the drug, Lovenox, a blood thinner with multi-billion-dollar sales. The Wall Street Journal reported that Woodcock’s close contacts with Momenta in the middle of a drug-approval process were ethically questionable. Momenta’s stock jumped 17% in a day.

On Oct. 1, 2020, Johnson & Johnson acquired Momenta Pharmaceuticals — this week, the FDA is expected to review Johnson & Johnson’s petition for Emergency Use Authorization for its single-dose COVID-19 vaccine.

The post Why Janet Woodcock Is the Wrong Person to Lead the FDA appeared first on Children’s Health Defense.

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