ASCO President Michael P. Link, MD, Makes Statement on Passage of FDA Safety and Innovation Act


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ASCO President Michael P. Link, MD, recently issued the following statement in response to the Senate Health, Education, Labor and Pensions Committee’s Passage of the FDA’s Safety and Innovation Act:

“ASCO commends the Senate Health, Education, Labor and Pensions Committee for taking steps to address a crisis in cancer care through its reauthorization of prescription drug user fee legislation. Drug shortages are continuing to strike hospitals and oncology practices and threaten patient care throughout the country. In cancer care alone, 19 different therapies remain in short supply.”

Dr. Link added that “The legislation’s creation of an interagency task force will help ensure that shortages are managed as efficiently as possible. We are also pleased that the bill requires manufacturers to give the FDA six-months’ notice of an anticipated shortage of a life-saving therapy. However, fines or some other type of enforcement mechanism are needed to ensure manufacturers comply with this requirement. ASCO hopes that this change may be added before final passage.”

Further, Dr. Link said “We thank Senators Tom Harkin [D-Iowa] and Michael Enzi [R-Wyo.] for their leadership on the drafting and committee approval of this legislation. We urge the full Senate to pass the bill with the drug shortages provisions as quickly as possible.” ■



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