Opinion ID: 2676869
Heading Depth: 3
Heading Rank: 2

Heading: FDA Approval

Text: When the FDA approves a drug, it does so on the basis of evidence of clinical trials submitted by the drug’s manufacturer. The FDA generally does not conduct its own trials. According to plaintiffs’ expert Dr. Lisa Rarick, who participated as an FDA official in the approval process for mifepristone, the FDA “does not authorize protocols for drugs . . . . Rather, approval of [a drug] allows the drug sponsor to advertise and promote the drug for a particular use.” The drug’s manufacturer also submits a proposed label for approval. The label “provides physicians with guidance about how to use a drug in accordance with how the drug sponsor requested and received FDA approval for its use.” The label “does not impose binding obligations on physicians.” The “FDA does not require a manufacturer to update a drug’s [label] for new uses or protocols,” and there rarely are sufficient economic incentives for the manufacturer to do so. According to Dr. Rarick, the FDA “neither prohibit[s] nor discourage[s]” off-label use of FDA-approved drugs. In fact, “the FDA has repeatedly acknowledged that off-label use is common and is sometimes required by good medical practice.” In a 1982 “FDA Drug Bulletin,” the FDA stated: The [Federal Food, Drug, and Cosmetic] Act does not . . . limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a PLANNED PARENTHOOD ARIZONA V. HUMBLE 9 physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature. . . . Valid new uses for drugs already on the market are often . . . confirmed by well- planned and executed clinical investigations. Before such advances can be added to the approved labeling, however, data substantiating the effectiveness of a new use or regimen must be submitted by the manufacturer to [the] FDA for evaluation. This may take time and, without the initiative of the drug manufacturer whose product is involved, may never occur. For that reason, accepted medical practice often includes drug use that is not reflected in approved drug labeling. 12 FDA Drug Bulletin 5 (1982). The FDA has consistently maintained that position. See U.S. Food & Drug Admin., “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices - Information Sheet (Aug. 10, 2011), http://www.fda.gov/RegulatoryInformation/ Guidances/ucm126486.htm. Off-label use of drugs is especially common in pediatrics, oncology, and gynecology and obstetrics. 10 PLANNED PARENTHOOD ARIZONA V. HUMBLE