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Administrative Law Keyed to Lawson
Professionals and Patients for Customized Care v. Shalala
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- The Brief Prologue provides necessary case brief introductory information and includes:
- Topic: Identifies the topic of law and where this case fits within your course outline.
- Parties: Identifies the cast of characters involved in the case.
- Procedural Posture & History: Shares the case history with how lower courts have ruled on the matter.
- Case Key Terms, Acts, Doctrines, etc.: A case specific Legal Term Dictionary.
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- The Case Brief is the complete case summarized and authored in the traditional Law School I.R.A.C. format. The Pro case brief includes:
- Brief Facts: A Synopsis of the Facts of the case.
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- Facts: What are the factual circumstances that gave rise to the civil or criminal case? What is the relationship of the Parties that are involved in the case. Review the Facts of this case here:
The FDA was aware of a problem in the pharmaceutical industry where pharmacies were purchasing large quantities of drug substances in bulk, combining them into other drug substances, and then marketing them (“compounding”). In order to combat this problem, it issued CPG 7132.16, a policy statement, to be used for internal agency guidance. The Guide outlined factors the FDA would consider in determining whether to bring an enforcement action. Plaintiff-Appellant claimed that the Guide was a substantive rule, and that notice and an opportunity to comment should have been afforded. The District Court concluded that the Guide was not a substantive rule, and therefore not subject to the APA’s notice and comment requirement.
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- Reasoning and Analysis: Identifies the chain of argument(s) which led the judges to rule as they did.
- The Brief Prologue closes the case brief with important forward-looking discussion and includes:
- Policy: Identifies the Policy if any that has been established by the case.
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