AAM raises concern over Trump budget’s potential exclusivity changes

BY Sandra Levy

Among President Donald Trump’s proposed budget for fiscal year 2020 are various changes meant to reduce costs — including a possible change to when first-to-file generic makers’ 180-day period of exclusivity begins.

While commending the administration’s efforts to focus on drug prices, Chip Davis, CEO of the Association for Accessible Medicines, noted that the proposal might have an adverse impact on patient out-of-pocket costs.

“The proposal to amend the 180-day period of exclusivity for first generics only weaken this critical incentive for competition and ensure that more non-innovative brand-name drug patents remain in place, delaying the availability of generic medicines for patients,” David said. “As a result, America’s patients will continue to pay high brand-name drug prices for longer without competition from more affordable FDA-approved generic medicine.”


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