6 J.L. & Pol'y 795 (1997-1998)
One-Half Phen in the Morning/One Fen before Dinner: A Proposal for FDA Regulation of Off-Label Uses of Drugs

handle is hein.journals/jlawp6 and id is 803 raw text is: ONE-HALF PHEN IN THE MORNING/ ONE FEN
BEFORE DINNER:
A PROPOSAL FOR FDA REGULATION OF OFF-
LABEL USES OF DRUGS*
Jaime A. Wilsker*
When a nearly untested drug combination enters the
obesity market in a country where people are willing to try
almost anything that promises to help them shed pounds,
you have a potential disaster on your hands.'
* The term off-label refers to the practice of prescribing drugs for uses that
have not been approved by the Federal Drug Administration (FDA). Marlene
Cimons, Public Policy: FDA 's Approval Process Faces Challenge in New Senate
Bill Finding the Proper Balance Between Protecting and Overburdening
Americans is at the Heart of Renewed Debate Over the Agency's Mission, L.A.
TIMEs, July 22, 1997, at A5. Fen-phen, for example, is a two-drug combination
that was not FDA approved. Id. (noting that some 40-60% of all prescriptions
are off-label uses). See also Fen/Phen: Unapproved Drug-2: Bill Seen Helping
Cancer Doctors, Dow JONES NEWS SERVICE, July 21, 1997, at 18:15:00;
Kathleen Kerr, Drug Makers Seek Return of Redux, N.Y. NEWSDAY, Nov. 12,
1997, at A24 (noting another example of off-label dispensing, namely, the drug
Redux (dexfenfluramine)). Although available in Europe for a long time, the
FDA approved Redux only last year after what some researchers believe was a
shallow review of the adverse effects. Terence Monmaney, Diet Drugs Said To
Kill Off Some Brain Cells, AUSTIN AMER.-STATESMAN, Aug. 27, 1997, at Al.
Similar to fen-phen, Redux is another controversial diet pill that has been
recently removed from pharmacies as a result of widespread concern with heart
valve problems. Kerr, supra, at A24. Manufacturers are seeking to put Redux
back on the market for treatment of psychiatric disorders. Kerr, supra, at A24.
** Brooklyn Law School Class of 1999; B.A., Vassar College, 1996. The
author wishes to extend a heartfelt thank you to her parents for their invaluable
advice, her sister for her continual support and to Howard Heath Tygar for his
love and encouragement.
Gina Kolata, Millions Flock to Diet Drugs, But Risks Are Emerging, PITTS-
BURGH POST-GAZETTE, July 20, 1997, at A3. Not since the 1970's craze with
amphetamines have diet pills gained such popularity. Id. Yet, this craze begs the

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