Blog & Resources Camargo Blog June 18th, 2012

REMS in Congress

I’m not into politics, but maybe some of my readers are and wish to contact their representative in the U.S. House of Representatives to share your thoughts on a pending issue.

With the introduction of REMS, innovator companies have used the restricted distribution feature to prevent other pharmaceutical companies from obtaining drug supplies that can be used for generic or 505(b)(2) drug development.

In preparing new amendments to the FD&C Act, Congress has been lobbied hard by both sides of the issue. A result is that the Senate version (see below) included a provision that would require innovators to provide drug supplies. The House did not have any provision.

The GPHA, the industry group representing the generic industry has lobbied the House based on a cost-savings basis. Since there is no industry group representing 505(b)(2) developers, I have informed the GPHA board of the 505(b)(2) issues. Of course, many generic companies are involved in 505(b)(2) drug development, but the GPHA needs to add to their argument that REMS is also preventing the improved safety and efficacy improvements that caused the originator drug to be restricted by REMS.

Categories: 505(b)(2) Development

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