Weinberger v. Hynson, Westcott & Dunning, Inc.
412 US 609, 1973 U.S. LEXIS 49, 37 L. Ed. 2d 207 (1973)
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Rule of Law:
An administrative agency may, consistent with statutory and due process requirements for a hearing, deny a full evidentiary hearing to an applicant who fails to present evidence that, on its face, meets the agency's validly promulgated regulatory standards for a threshold showing of proof.
Facts:
- Hynson, Westcott & Dunning, Inc. (Hynson) manufactured a drug named Lutrexin.
- Prior to 1962, the Food and Drug Administration (FDA) approved a New Drug Application (NDA) for Lutrexin, permitting it to be marketed because it was considered safe for its intended use.
- In 1962, Congress amended the Food, Drug, and Cosmetic Act to require that drugs be proven effective, not just safe, based on 'substantial evidence.'
- The FDA retained the National Academy of Sciences-National Research Council (NAS-NRC) to review the effectiveness of thousands of drugs approved before 1962, including Lutrexin.
- Hynson submitted a list of literature references, an unpublished study, and a sample testimonial letter as evidence of Lutrexin's effectiveness.
- The NAS-NRC panel reported to the FDA that Hynson's submissions did not contain adequate documentation to support its claims of effectiveness.
- The FDA Commissioner, after reviewing Hynson's submissions, concluded the evidence was inadequate because it did not consist of the 'adequate and well-controlled investigations' required by new FDA regulations.
Procedural Posture:
- The FDA announced its intention to withdraw approval of Lutrexin and offered Hynson an opportunity for a hearing.
- Hynson filed suit in U.S. District Court seeking a declaratory judgment that the drug was exempt from the 1962 amendments' efficacy provisions.
- The District Court granted the government's motion to dismiss, ruling that Hynson had failed to exhaust its administrative remedies.
- While the suit was pending, the FDA promulgated new regulations allowing for the summary denial of a hearing if an applicant's evidence was facially insufficient.
- Hynson submitted its evidence, but the FDA Commissioner denied the request for a hearing and issued a final order withdrawing the New Drug Application (NDA) for Lutrexin.
- Hynson appealed the Commissioner's order to the U.S. Court of Appeals for the Fourth Circuit.
- The Court of Appeals reversed the FDA's order, holding that while the drug was not exempt, Hynson was entitled to a hearing on the issue of its effectiveness.
- The U.S. Supreme Court granted certiorari at the request of both the government (Weinberger) and Hynson.
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Issue:
Does the Federal Food, Drug, and Cosmetic Act, which requires the FDA to provide 'due notice and opportunity for hearing' before withdrawing approval of a drug, permit the agency to deny such a hearing when a drug manufacturer fails to submit evidence meeting the regulatory definition of 'adequate and well-controlled investigations'?
Opinions:
Majority - Mr. Justice Douglas
Yes. The Federal Food, Drug, and Cosmetic Act permits the FDA to deny a hearing when it conclusively appears from the applicant's submission that they cannot succeed because their evidence fails to meet the statutory and regulatory standards for 'substantial evidence.' The Court reasoned that Congress intended to impose a rigorous standard of 'adequate and well-controlled investigations' to ensure drug efficacy. Citing precedents like United States v. Storer Broadcasting Co., the Court held that an agency has the authority to particularize statutory standards through rulemaking and summarily deny a hearing to applicants who fail to meet them. Requiring the FDA to conduct a full hearing for every manufacturer that submits scientifically invalid evidence would paralyze the agency and defeat the Act's purpose of promptly removing ineffective drugs from the market. Due process does not require a futile hearing when the applicant's 'pleadings' show they cannot prevail. However, the Court also found that Hynson's specific submission was sufficient to warrant a hearing, and thus affirmed the Court of Appeals' judgment on that point.
Concurring - Mr. Justice Powell
Agrees with the result but not the broader reasoning. The concurring opinion agrees that Hynson's submission was sufficient to raise a 'genuine and substantial issue of fact' that required a hearing. However, the opinion expresses doubt as to whether the FDA's regulations, as construed by the Commissioner to deny a hearing for a drug used for two decades, are compatible with the statute or the Due Process Clause. Justice Powell argues that the Court should not have given broad approval to the FDA's summary judgment procedure in this case, as these complex constitutional questions were not squarely presented and their resolution was unnecessary to the decision. He suggests that the question of whether the FDA's rigorous threshold requirements frustrate the congressional mandate for a hearing should be decided in a future case.
Analysis:
This decision is a landmark in administrative law, establishing the principle of 'administrative summary judgment.' It affirms an agency's power to set specific evidentiary standards through rulemaking and to deny a statutory right to a hearing for parties who fail to meet that threshold. This enhances agency efficiency by allowing them to dispose of meritless claims without conducting costly and time-consuming evidentiary hearings. The ruling significantly strengthens the FDA's ability to enforce the 1962 Drug Amendments' efficacy requirements but also preserves judicial oversight, as courts can still review whether an agency's denial of a hearing was appropriate based on the applicant's submission.
