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Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper – Forbes

By May 5, 2012No Comments

US Secretary of Health and Human Services Kathleen Sebelius (R) speaks alongside Food and Drug Administration (FDA) Commissioner Margaret Hamburg during the Daily Press Briefing in the Brady Briefing Room of the White House in Washington, DC, June 21, 2011. (Image credit: AFP/Getty Images via @daylife)

Last Friday, Forbes health care editor Matt Herper and I sat down to talk about my proposal, which I detailed in a paper for the Manhattan Institute, to encourage the FDA to approve more drugs after mid-stage phase II testing, using a process called “conditional approval.” (You can read my proposal, in three parts, here.) Matt put forth some very perceptive critiques of the idea, which I respond to in today’s dispatch.

As a refresher, my proposal builds on an existing FDA procedure called accelerated approval in which the FDA approves drugs that show great promise in phase II, with the caveat that the drug sponsor must still perform confirmatory phase III studies. If the phase III studies ultimately show that the drug doesn’t work as advertised, or has previously unknown safety issues, the FDA can revoke its approval. This is exactly what happened when the FDA revoked the approval of Avastin in breast cancer, after phase III tests did not reproduce the early signal of benefit that the drug had shown in phase II studies.

To read the full, original article click on this link: Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper – Forbes

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