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Politicians involved in FDA raise red flags

It was just one man’s opinion but it’s concerning nonetheless — for the long term as well as the short term.

In an interview with the Wall Street Journal, an interview about which the newspaper reported on Feb. 17, Dr. Richard Pazdur alleged that fast-track drug approvals had been politicized in a manner in which he never had experienced in his 26 years at the federal Food and Drug Administration.

Pazdur was a top federal drug regulator at the time of his abrupt departure from the FDA in December. Pazdur, who is an oncologist, had “scrutinized applications for cancer treatments for more than a quarter of a century at the FDA before leading its drug division,” the Journal said in its Feb. 17 article. “He was known for evolving from a conservative stance — hesitant to grant approvals — to finding new ways to push new drugs out faster. That is because the past two decades have brought scientific advancements that made new cancer drugs much better, Pazdur said.”

As the FDA’s drugs chief, the Journal said, Pazdur was responsible for thousands of employees overseeing most of the new medicines the FDA considers for approval, as well as generic and over-the-counter drugs.

With his position came awesome responsibility, but Pazdur was believed to be the right person to shoulder that responsibility.

Because he’s now at odds with the FDA over decisions made within the important agency — decisions that prompted the resignation that he did not intend to happen — the American public should take notice and feel at least some concern, because of the important duties for which he was responsible.

Safe, effective medicines are in everyone’s best interests, and skepticism on the part of someone so important for so long should not be ignored or attributed to the simplistic notions “sour grapes” or “clashes of personalities.”

In his interview with the Journal, Pazdur made clear that he is concerned about much more than a simplistic matter. Meanwhile, the center of that concern is not something most Americans would be willing to pooh-pooh, once they understood what is at stake.

The point of disagreement between Pazdur and the new thinking at the FDA is the number of clinical trials that should be conducted before a medication gets the go-ahead for use.

Pazdur objected to a proposal to require just one clinical trial for drug approvals, down from the original two.

“All of a sudden, I was given a press release with a quotation by myself written in it, and asked to just agree to it,” he said.

Unlike what had just happened, Pazdur said, prior FDA commissioners carefully avoided interfering in individual drug approvals, letting the scientific reviewers have sway.

Again referring to what had happened, Pazdur said the FDA commissioner went public with the proposal without addressing Pazdur’s concerns, the “wall” between the commissioner’s office and the review staff having been breached.

Pazdur said that incident and what he described as other frustrations led to his departure. Of worse concern, he said, is that the FDA’s future is unclear and that that must be a significant concern of the American people.

What’s most significant, though, is that the FDA never was meant to be “run” by politics and, if Pazdur is correct, there is troubling movement in that direction.

That movement must cease.

Politics must not be a component of any medicine.

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