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US Senators propose bill to expedite FDA approval for drugs approved in other countries US Senators propose bill to expedite FDA approval for drugs approved in other countries

Bronze medal Reporter Adv. John Posted 20 Jul 2019 Read More News and Blogs
US Senators propose bill to expedite FDA approval for drugs approved in other countries

US Senators Ted Cruz (R-TX) and Mike Lee (R-UT) introduced a bill on Thursday that proposes to fast-track FDA approval for drugs and medical devices already authorized in other countries.

Known as the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act, or the RESULT Act, the bill advocates for the reciprocal approval of drugs.

In his press release, Cruz claimed the bill will effectively combat US drug shortages and drive down the prices of drugs and medical devices.

Specifically, the RESULT Act would give the FDA 30 days to approve or deny an application. Congress would maintain the power to override this decision if necessary. The Act would require applicants to show evidence that their product has approval in one of specified countries enumerated. Additionally, applicants would have to prove that their product fulfills a public health or medical need.

Cruz noted the RESULT Act would “reform the FDA and champion innovation,” and Lee later added “much broader reform of the FDA is needed, but this common-sense legislation would at least help some of the most vulnerable among us get the lifesaving treatments.”

https://www.jurist.org/news/2019/07/us-senators-propose-bill-to-expedite-fda-approval-for-drugs-approved-in-other-countries/

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