New FDA Bill Offers Hope for the Desperate
The Access to Medical Treatment Act (H.R. 746 ), a bipartisan bill being introduced in the House today, marks a step forward in both medicine and human rights, the Competitive Enterprise Institute said today. Co-sponsored by Reps. Peter DeFazio (D-Or) and Joe Barton (R-Tx), among others, AMTA would, in its words, "allow patients to receive any medical treatment they want under certain conditions," specifically the informed consent of the person being treated. AMTA would not change any of the Food and Drug Administration's approval criteria.
"For too long, FDA regulations have prevented desperately ill patients from trying new and different treatments, some of which are available abroad," noted CEI policy anaylst Julie DeFalco. "The Access to Medical Treatment Act would place these medical decisions in the hands of patients and doctors, rather than FDA bureaucrats."
While critics of AMTA claim that it would open the door to "snake oil," the reality is that even mainstream doctors agree with the bill's approach. In two polls of cardiologists and oncologists sponsored by CEI, majorities of these heart and cancer specialists supported the principle underlying AMTA. When asked, "What would your position be on a proposal to change the FDA law so that unapproved drugs and devices could be made available to physicians as long as they carried a warning about their unapproved status?," 53% of cardiologists and 61% of oncologists favored such a change.
"Doctors on the cutting edge of medicine recognize the human cost of the FDA's delays in approving new therapies," said DeFalco. "It's good that Congress does, too."
To address the legal and consumer issues of expanded access to medical therapies, CEI recently released a study by George Mason University law professor Michael Krauss, entitled Breaking the FDA's Drug Approval Monopoly -- Implications for Tort Law and Consumer Welfare, published in the GMU Law Review in September, 1996. It concludes that the FDA's current command-and-control approach to approving new therapies hurts the interests of those it purports to benefit.
For more information, contact Greg Smith at (202) 331-1010 or gsmith@CEI.org.