Ubiotica Corp. v. Food & Drug Administration
427 F.2d 376 (1970)
Rule of Law:
The FDA Commissioner may properly refuse a New Drug Application (NDA) when the applicant fails to carry the burden of providing substantial evidence of safety and efficacy through adequate testing and manufacturing controls, and administrative due process does not mandate subpoena power or broad discovery of agency files.
Facts:
- Ubiotica Corporation developed a 'U' Series Drug consisting of approximately fifty separate ingredients intended for the treatment of mongolism (Down syndrome).
- Dr. Turkel, the developer, administered the drug to patients under medical supervision for several years.
- A 'double blind' study conducted by Dr. Bumbalo on children with mongolism compared the drug to a placebo over a one-year period.
- The Bumbalo study results showed no physical or mental progression in the patients, although Ubiotica did not submit these negative results with its application.
- Animal studies conducted on rats and dogs resulted in frequent vomiting, making absorption levels unclear, and lacked detailed pathology reports or slides.
- The scientist who conducted the animal studies admitted he could not state the drug would not produce toxic effects at the indicated dosage levels.
- The manufacturing data failed to list all substances used in the drug's synthesis or the composition of the capsule shells.
- The samples provided by Ubiotica weighed more than the sum of the ingredients listed on the proposed label.
Procedural Posture:
- Petitioner submitted an original New Drug Application (NDA) and Claim for Investigational Exemption.
- The Commissioner issued an order terminating the investigational exemption.
- Petitioner unsuccessfully sought to enjoin the termination order in the U.S. Court of Appeals for the Sixth Circuit (Turkel v. FDA).
- Petitioner withdrew the original NDA.
- Petitioner submitted a second, supplemental NDA.
- The Commissioner notified Petitioner of the proposal to refuse approval of the NDA.
- An administrative hearing was held, during which the Examiner denied Petitioner's motions for documents and excluded Petitioner's counsel for misconduct.
- The Commissioner issued a final order refusing to approve the NDA and terminating the investigational exemption.
- Petitioner filed a petition for review of the Commissioner's order in the U.S. Court of Appeals.
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Issue:
Does substantial evidence support the FDA Commissioner's refusal to approve a new drug application and termination of an investigational exemption where the applicant failed to provide adequate tests of safety and efficacy, and were the applicant's due process rights violated by the denial of document requests and the exclusion of counsel during the administrative hearing?
Opinions:
Majority - Combs
Yes, the Commissioner's order is affirmed because the applicant failed to meet its statutory burden of proving the drug was safe and effective, and the administrative hearing was conducted fairly despite the procedural challenges. The Court held that under 21 U.S.C. § 355, the burden rests entirely on the applicant to prove safety and efficacy. The Court found substantial evidence supporting the Commissioner's rejection, citing the lack of objective clinical data, the inadequate animal toxicity studies where animals vomited frequently, and severe deficiencies in manufacturing controls. Regarding the investigational exemption, the Court found the termination was not arbitrary because the initial submission lacked basic ingredient and stability data. Procedurally, the Court ruled that the lack of subpoena power in the statute does not violate due process. Furthermore, the Court rejected the Petitioner's attempt to apply the Jencks doctrine to access the entire FDA file, noting that the request was overly broad. Finally, the Court held that the exclusion of the Petitioner's counsel from the hearing was justified because his conduct was 'dilatory, recalcitrant, and obstructive,' and the Petitioner was not denied a fair hearing as new counsel was permitted to take over.
Analysis:
This case reinforces the strict burden of proof placed on pharmaceutical companies seeking to introduce new drugs into interstate commerce. It clarifies that the FDA is not required to prove a drug is unsafe; rather, the applicant must affirmatively prove it is safe and effective using adequate methods. The decision highlights that anecdotal evidence or incomplete clinical reports are insufficient to override statutory requirements for rigorous scientific data, such as double-blind studies and detailed manufacturing controls. Procedurally, the case limits the scope of discovery in administrative hearings, establishing that the Jencks rule cannot be used as a 'fishing expedition' for agency files and confirming that administrative law judges have the authority to control the conduct of hearings, including the exclusion of disruptive counsel.
