Regulatory Focus™ > News Articles > Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

Posted 23 April 2012 | By

Former US Food and Drug Administration (FDA) Commissioner Mark McClellan, now a member of the think tank The Brookings Institute, penned an opinion piece in The Hill in which he argues FDA must take advantage of a "paradigm shift" in our understanding of specific pathways of disease to get treatments to patients faster.

"Our progress in understanding the specific pathways of disease has identified hundreds of new targets for potentially life-saving drugs that hold the potential to treat individual patients much more effectively," wrote McClellan and Ellen Sigal of the group Friends of Cancer Research.

This emergence of new information, understanding and technologies should allow FDA regulators to develop new approaches that focus on the "most efficient mechanisms to get a potential medical breakthrough to the relevant patients," wrote McClellan and Sigal.

Noting FDA has already taken "a number of promising steps to respond to these new trends in medical product development, " the duo explain there is more work to be done.

McClellan and Sigal identify a piece of proposed legislation sponsored by Sens. Bennet (D-CO), Hatch (R-UT) and Burr (R-NC) that would create a so-called "breakthrough product designation" to bring products to market faster.

The legislation has two goals both McClellan and Sigal agree with:

  • 1) "to reduce the total development time and cost of the most promising "breakthrough" treatments."
  • 2) "to minimize the number of patients that would be given a "control" regimen or a currently available treatment that doesn't work well."

"This legislation does not alter current FDA standards and any new drug would continue to be required to fully demonstrate both safety and efficacy," explained McClellan and Sigal, but it would have a powerful effect on product development.

"It would signal to developers that, for the most promising products to battle severe illness and disease, the FDA will actively marshal these products through the course of development - and would help them identify the most efficient ways to develop their drugs."


Read more:

The Hill - Getting drugs to market place faster

Regulatory Focus - Senators Draft Bill to Expedite Drug Approval

Regulatory Focus - Bill Looks to Make Changes to FDA's Accelerated Approval Pathway

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