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PHARMACEUTICAL MFG. RESEARCH v. FOOD & DRUG ADMIN.

No. 18-1335.

957 F.3d 254 (2020)

PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES, INC., Petitioner, v. FOOD & DRUG ADMINISTRATION, et al., Respondents.

United States Court of Appeals, District of Columbia Circuit.

Decided May 1, 2020.

Attorney(s) appearing for the Case

Elizabeth P. Papez argued the cause and filed the briefs for petitioner.

Sarah Carroll , Attorney, U.S. Department of Justice, argued the cause for respondents. With her on the brief were Scott R. McIntosh , Attorney, Robert P. Charrow , General Counsel, U.S. Department of Health and Human Services, and AnnaMarie Kempic , Deputy Chief Counsel, Litigation.

Before: Henderson, Wilkins, and Rao, Circuit Judges.

Before bringing a new drug to the market, a pharmaceutical manufacturer must demonstrate to the Food and Drug Administration that the drug is safe, effective, and works as described. Here, petitioner Pharmaceutical Manufacturing Research Services ("PMRS") sought approval to market a prescription opioid drug that PMRS claims will...

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