FDA Approved Drug Classification

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7^th Circuit Court of Appeals

Case Name:  Rodney Guilbeau, et al. v. Pfizer Inc., et al

Case No.: 17-2056

Officials: BAUER and HAMILTON, Circuit Judges, and DARROW, District Judge.

Focus: FDA Approved Drug Classification

This appeal arises from the district court presiding over thousands of related claims against manufacturers of testosterone replacement therapy drugs. We must consider how to apply Levine and Mensing to a manufacturer of a drug that does not fit neatly into the colloquial dichotomy between brand-name and generic drugs. We must look at the more precise legal and regulatory context underlying those terms, focusing on whether the U.S. Food and Drug Administration (FDA) approved public sale of the drugs through the “new drug application” or NDA process, or instead through the “abbreviated new drug application” or ANDA process. We have tried to minimize use of impenetrable acronyms, but readers are warned that some are unavoidable.

The most those letters show is that the CBE process might have been used in the early 1990s to make Depo-T’s label conform with a change in federal law, and perhaps again to avoid confusion at the request of a different federal agency. These kinds of CBE changes are not relevant to our preemption analysis because they focus on using the regulation for reasons other than adding additional warnings, the sole issue of concern here. In addition, though further discovery may reveal more about the defendants’ view of the CBE regulation from past decades, it would not be likely to uncover what the plaintiffs actually need: the FDA’s policy before Mensing was decided in 2011 about whether ANDA holders like Upjohn could have added warnings through the CBE process. The plaintiffs already have available to them the process they might need for that kind of discovery—the Freedom of Information Act, 5 U.S.C. § 552 et seq. The district court did not abuse its discretion by denying discovery on this point.

We AFFIRM the decisions of the district court challenged in this appeal, apart from those vacated by the separate jurisdictional order issued today.

Affirmed

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Attorney Derek A. Hawkins is the managing partner at Hawkins Law Offices LLC, where he heads up the firm’s startup law practice. He specializes in business formation, corporate governance, intellectual property protection, private equity and venture capital funding and mergers & acquisitions. Check out the website at www.hawkins-lawoffices.com or contact them at 262-737-8825.