Effective Drug Control: Toward A New Legal Framework

Tobacco products and advertising were on the verge of being regulated by the
Food and Drug Administration after the U.S. Senate passed a bill in mid-2004, but the
leadership in the U.S. House of Representatives blocked the action. Health care
advocates are pushing for FDA oversight of tobacco after an adverse U.S. Supreme Court
decision in 2000 declaring the agency's earlier claim of authority over tobacco
unconstitutional. 453 If approved, the bill would have allowed the FDA to regulate the sale,
distribution, labeling and advertising of cigarettes and smokeless tobacco, as well as the
ability to require manufacturers to better disclose the contents and consequences of their
products in new, stronger warning labels on packages. 454
Pharmaceuticals and the “Gray Market”
Pharmaceuticals are regulated federally by the Drug Enforcement Administration
(DEA), the Food and Drug Administration (FDA), the Consumer Products Safety
Commission (CPSC), the Centers for Medicare and Medicaid Services (CMS) and the
Occupational Safety and Health Administration (OSHA). Also operating on the national
level is the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), a
non-profit organization that evaluates and accredits health care organizations and
programs in the U.S. In the state of Washington pharmaceuticals are regulated by the
Board of Pharmacy, the Department of Social and Health Services, the Department of
Ecology, and the Department of Labor and Industries.
The DEA regulates the manufacture, distribution, possession, storage and disposal
of pharmaceuticals. The regulation of pharmaceuticals is a closed system where
everyone must register with the DEA, including manufacturers, distributors, prescribers
and pharmacies, and records, prescriptions and order forms are all required. In the state
of Washington there is a Board of Pharmacy that oversees pharmaceuticals in the state
under the Legend Drug Act 455 and the Uniform Controlled Substances Act, 456 and there
are professional boards that oversee professionals who work with and around
pharmaceuticals.
Drugs are classified as over the counter (OTC), prescription (legend drugs), or
controlled substances. There is no supervision for provision of OTC drugs, while
prescription drugs can only be used under authorization by a physician under federal law.
Controlled substances are classified into five schedules under the Controlled Substance
Act according to potential for abuse. The DEA issues licenses to physicians to prescribe
controlled substances. While the prohibited substances under Schedule I cannot be
prescribed, as they have no approved medical use, substances under Schedule II can be
prescribed with non-refillable written prescriptions. Substances in the lower schedules
are less strictly controlled, with some Schedule V substances available over the counter.
Prescription authority must be authorized under state law, which is governed by
the Legend Drug Act, Food Drug and Cosmetic Act, Uniform Controlled Substances Act,
Profession’s Practice Act, and rules adopted under these laws. Physicians with the
degrees of M.D. and D.O. (osteopaths) have no restrictions on their prescribing authority,
while dentists, nurse practitioners, nurse anesthetists, physician assistants, optometrists,
naturopaths and veterinarians all have restrictions on their prescribing authority. Drugs