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Wednesday, June 19, 2024 | Back issues
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Doctors Can’t Sue FDA|Over Drug’s Approval

(CN) — The Ninth Circuit ruled Monday that a doctors' nonprofit does not have standing to sue the U.S. Food and Drug Administration over the agency's failure to revoke approval for the drug roflumilast.

Physicians for Integrity in Medical Research, a group of physicians dedicated to ensuring that all FDA-approved drugs and devices are safe for patients, filed a lawsuit in February 2014 over the FDA's decision not to revoke its February 2011 approval of roflumilast.

The drug, with trade names Daxas and Daliresp, is used for treating chronic obstructive pulmonary disease. The group claimed roflumilast does not work well and frequently causes side effects.

A federal judge dismissed the doctors' lawsuit for lack of standing and a Ninth Circuit panel agreed.

"Any alleged injury must have a 'causal connection . . . [to] the conduct complained of — the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court,' " the panel said in its unanimous per curiam opinion, citing the 1992 case Lujan v. Defenders of Wildlife.

The complaint included a declaration by Dr. Nilesh Desai, who claimed that roflumilast will cause him to lose patients and that "he will be uncompensated for the time he spends explaining to patients his beliefs regarding roflumilast."

But the panel found Desai's declaration does not give him or the nonprofit standing to sue the FDA.

"Even assuming that Dr. Desai has suffered injuries-in-fact, these injuries would arise from the independent decisions made by his patients," the panel said. "Patients who choose to stop seeing Dr. Desai as a result of Dr. Desai's comments regarding roflumilast, or who end up finding him less reputable, are making an independent choice unrelated to the FDA's actions."

The panel also rejected the nonprofit's argument that failing to grant it standing to sue means no one can have standing to sue. This position "is not supported by case law," the panel said.

Physicians for Integrity in Medical Research was represented in the original complaint by Dr. Steve Gupta of La Canada, California. He said the nonprofit plans to petition for a rehearing en banc.

"I hope the full bench gives us an opportunity to present the case again," he said.

The FDA could be reached for comment.

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