The U.S. Food and Drug Administration is the focus of NDSU's first Science Café of the academic year, scheduled for Tuesday, Sept. 8, at 7 p.m. in Stoker's Basement at the Hotel Donaldson in downtown Fargo. The event is free and open to the public.
Donald Miller, professor of pharmacy practice at NDSU, is set to present "The FDA and Drug Regulation in America: Balancing innovation and the public’s need for safe, effective medicine."
Miller, who is a member of the FDA Arthritis Advisory Committee, will give his perspective on how the agency works, and describe how new legal rulings and pending congressional legislation may change the ability of FDA to provide balanced regulation.
According to Miller, public opinion is divided on the agency – some believe the FDA is a pawn of the drug industry, while others think its regulations are restrictive. He said the FDA seeks adequate evidence of safety and effectiveness for drugs before approval.
"Congress is looking at legislation called 'The 21st Century Cures Act' that is aimed at speeding up FDA approval of drugs, so Congress seems to be under the assumption the FDA is getting in the way of innovation," Miller explained. "I think there is a lot of misunderstanding of how drugs are developed and why it takes some time. I'm afraid the new legislation may push us to the point where the FDA is a paper tiger and it may be forced to approve everything with very flimsy evidence."
Miller earned his bachelor's degree at the University of Manitoba and his Doctor of Pharmacy at the University of Michigan.
Attendees must be 21 or older or accompanied by a parent or guardian. For more information, contact Diane Goede at email@example.com or 701-231-7412.
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