PRESCRIPTION FOR TROUBLE
March 6, 2007
Recently, government agencies -- in their belief that doctors cannot heed safety warnings -- have hatched rules that dictate when treatments should be delivered and even how they can be administered -- especially when it comes to new drugs, says Scott Gottlieb, resident fellow at the American Enterprise Institute.
The result is increasing federal regulation of medical practice that constrains health care providers and limits the choices patients have. Under the latest proposal, offered by Edward Kennedy (D., Mass.) and Michael Enzi (R., Wyo.):
- The Food and Drug Administration's (FDA) ability to restrict which physicians can prescribe a medicine and which pharmacies can dispense it, would be increased through risk-management plans that would accompany the approval of many new drugs.
- These "RiskMAPs," as they are called, already guide the use of about 30 marketed drugs as part of "voluntary" arrangements with drug companies.
Reflecting this pervasive mistrust of medical practitioners, others are jumping in, says Gottlieb:
- Medicare is increasingly tying payments to the choices doctors make, compensating doctors more to follow certain cookie-cutter treatments or practice guidelines that are promoted by the agency because they are believed by government experts to maximize benefits or reduce health-care costs.
- The Drug Enforcement Administration is seeking legislative authority that would give it a role in limiting the approvals of new pain products -- even though the agency has no ability to appreciate the public health considerations that create a medical need for better drugs.
All of these approaches harm patients because they impose one-size prescriptions in an area of science that is marked by variation. Furthermore, parameters on the prescription of new drugs create obstacles for patients who already face significant problems getting access to the latest drugs or the specialists who are ordained by FDA's RiskMAPs to prescribe them, says Gottlieb.
Source: Scott Gottlieb, "Prescription for Trouble," Wall Street Journal, March 6, 2007.
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