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Pharmaceuticals / Regulatory Affairs

Republican Senators Prod FDA to Expand Parallel Track

June 5, 2019

Four Republican senators are urging Acting FDA Commissioner Ned Sharpless to expand the agency’s Parallel Track program to give patients with incurable diseases a chance at recovery.

Regulators launched Parallel Track in 1992 to give HIV/AIDS patients access to treatments that hadn’t been approved yet. Now, Sens. Ted Cruz (R-Texas), Rand Paul (R-Ky.), Mike Braun (R-Ind.) and Mike Lee (R-Utah), say they want the program expanded to dementia, cancer and ALS.

The letter carries none-too-subtle threats about Sharpless’ future—and the agency’s funding. “As we examine the budget of the FDA and its potential new leadership,” it says, “we are looking for evidence that the agency seeks to act as a bridge—not a barrier—to innovation.”

The letter implies that former Commissioner Scott Gottlieb resisted efforts to expand Parallel Track. It opens, “With the change in leadership” at the agency, “there is a unique opportunity for the FDA to better prioritize bringing life-saving drugs to patients faster and at a lower cost.”

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