Off-Label Uses Of Drugs Should Be Approved For Very Ill Patients, Opinion Piece States

Main Category: Cancer / Oncology
Also Included In: Primary Care / General Practice;  Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 06 May 2009 - 4:00 PDT

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FDA and Congress "should protect physicians' and patients' right" to use FDA-approved drugs for off-label uses "and for the first time allow drugmakers to promote off-label uses that prove beneficial," Richard Epstein, a law professor at the University of Chicago and a senior fellow at the Hoover Institution, writes in a Wall Street Journal opinion piece. He continues, "Right now these drugs provide immense lifesaving opportunities for many sick patients, particularly those threatened by cancer."

Epstein writes, "Cancer patients are often in desperate straits" and "when existing treatments fail, patients and physicians alike can rationally conclude that they lose nothing by rolling the dice." He continues, "Clinical trials sometimes give way to educated guesses that a drug approved for one kind of tumor might treat a second," adding, "In many instances the result is failure." However, "when early results from clinical trials suggest favorable results on which the FDA is unwilling to act, off-label use begins in earnest," Epstein writes.

Epstein writes, "Any reliable information about what drugs work has the potential to save lives -- but the FDA's slow and ponderous system can't respond in real time to new data." He adds, "As matters now stand, no off-label use is possible for any drug that has not been certified for some particular on-label use," which "reduces the number of drugs available on the market for off-label experimentation."

Epstein continues, "No one thinks that unapproved cancer drugs should be freely available to patients in the over-the-counter market." However, making drugs that pass Phase I clinical trials available for general distribution is an option. He concludes, "This may sound radical. But when lives are at stake, we should consider drastic measures" (Epstein, Wall Street Journal, 5/2).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

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