Administrative Law Keyed to Lawson
Professionals and Patients for Customized Care v. Shalala
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.
Only StudyBuddy Pro offers the complete Case Brief Anatomy*
Access the most important case brief elements for optimal case understanding.
*Case Brief Anatomy includes: Brief Prologue, Complete Case Brief, Brief Epilogue
- 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.
Case Doctrines, Acts, Statutes, Amendments and Treatises:Identifies and Defines Legal Authority used in this case.
- 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.
Rule of Law:Identifies the Legal Principle the Court used in deciding the case.
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.
Issue(s):Lists the Questions of Law that are raised by the Facts of the case.
Holding:Shares the Court's answer to the legal questions raised in the issue.
Concurring / Dissenting Opinions:Includes valuable concurring or dissenting opinions and their key points.
Reasoning and Analysis:Identifies the chain of argument(s) which led the judges to rule as they did.