Government Limiting Physicians' Independence, Patients' Choices, Opinion Piece Says

Main Category: Public Health
Also Included In: Primary Care / General Practice
Article Date: 08 Mar 2007 - 4:00 PDT

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FDA, CMS and the Department of Justice "all believe they cannot rely on many doctors to heed safety warnings, wisely weigh new medical information or follow treatment approaches that maximize health benefits or lower costs," American Enterprise Institute resident fellow Scott Gottlieb writes in a Wall Street Journal opinion piece. He adds that as a result, the federal government increasingly is constraining health care providers and limiting patient choices. The situation "might get worse" because of a proposal by Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) that would extend FDA's "ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it, through risk-management plans that would accompany the approval of many new drugs," Gottlieb writes. These plans are known as "RiskMAPs" and already are used for some new, potentially dangerous drugs. Gottlieb writes that RiskMAPs "impose burdens, especially on patients who already face difficulty obtaining the specialist care that many RiskMAPs require." Meanwhile, the Drug Enforcement Administration has sought legislative authority to limit FDA approvals of new pain products in order to reduce prescription drug abuse, and the Department of Justice is waging a "war on off-label promotion by drug companies [that] ends up criminalizing the exchange of truthful, non-misleading medical information with doctors on new uses for medicines," according to Gottlieb. "All of these approaches harm patients because they impose one-size prescriptions in an area of science that is marked by variation," Gottlieb writes, concluding that the "solutions to any of the health care problems that government is trying to mitigate will not rest in Washington's constraining 'fixes' but with [medical organizations] working with agencies to promote practice standards and safety measures that do not sacrifice medical autonomy and patient choice" (Gottlieb, Wall Street Journal, 3/6).

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