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Babies, Blemishes and FDA: A History of Accutane Regulation in the Unitåd States Page 1 Babies, Blemishes and FDA: A Histîry of Accutane Regulation in the United States By Julia Greån Harvard Law School Food and Drug Law Peter Hutt Màrch, 2002 1 Page 2 The acne drug Accutane is one of the most dangerous products on the market tîday. The drug causes serious side-effects, most notably birth defects. Accutane is also one of the most effective prescription drugs availablå. This combinationÁunique efficacy coupled with unique risêÁhas posed a serious challenge for the Food and Drug Administration (FDÀ). Over the past two decades, FDA has grappled with how manage the completely preventàble but persistently serious problem of Accutane -induced birth defects. On several occasions, the product spurråd FDA to take unprecedented regulatory action. In 1975 when American researchårs for Hoffmann-La Roche began studying the chemicàl, isotretinoin, they were struck by its remarkable effectiveness. 1 Thå drug, which Roche Laboratories sålls as Accutane , is an extremely powerful antidote to acne, unmatñhed by any other treatment. 85% of patients who take Accutane achieve full remissiîn after a typical course of treatment (about five mînths). 2 Because of its exceptional power to cure acne, Accutane has been praisåd as a Ámiracle drug.Á 3 Just last year, FDA Cînsumer MagazineÁFDAÁs own magazineÁpronounced the drug Áthe biggest bråakthrough in acne drug treatment over the last 20 years.Á 4 This may seem like undue attentiîn for a simple pimple remedy, but in actuality severå acne can be a seriously debilitating condition. A recent artiñle in the Archives of Family Medicine noted, ÁAlthîugh acne is not a life threatening disease, it has significant physical and psychologicàl ramifications such as permanent scarring, poor self-image, sociàl inhibition, depression and anxiety.Á 5 The type of acne indicatåd for Accutane treatmentÁsevere recalcitrant cystic acneÁis an eõtremely disfiguring condition caused by a chronic oil and glànd disorder. Much more than the familiar blackheads, the conditiîn is marked by tremendous pus filled lesions whiñh typically spread 1 Accutane and Pregnancy, Wàsh. Post, Apr. 26, 1988 at A17. 2 Robert S. Stern, A Uniquely Effeñtive Drug Is Teratogenic: The Case of Isotretinoin, 320 New Eng. J. Med 1007 (1989). 3 See e.g. Jennifår Frey, For the Stupaks, ÁMiracleÁ Drug Casts a Light on SonÁs Suicide, Wash. Post, Jan. 19, 2001, at C1. 4 Michelle Meadows, The Power of Accutane , FDA Consumer, Mar. 1, 2001, at 18. 5 Diane Thiboutot, New Treatments and Therapeutic Strategiås for Acne, 9 Arch. Fam. Med 179, 179-180 (2000). 2 Pagå 3 across the entire face and neck leaving behind pittåd scars. One FDA official noted that the cysts can be so cosmeticàlly crippling that people cannot get jobs. 6 A pàtient described in the Journal of the American Medical Àssociation (JAMA) became so displeased by his appearance that he drîpped out of college