Serono Laboratories, Inc. v. Shalala
158 F.3d 1313 (1998)
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Rule of Law:
An administrative agency's interpretation of an ambiguous statutory term, such as requiring "sameness" between a pioneer and generic drug, is entitled to judicial deference under Chevron so long as the interpretation is reasonable and based on the agency's scientific and technical expertise.
Facts:
- Serono Laboratories, Inc. (Serono) manufactures Pergonal, a pioneer infertility drug approved by the FDA in 1969.
- Pergonal is a menotropins product extracted from natural sources, containing active ingredients follicle-stimulating hormone (FSH) and luteinizing hormone (LH), as well as inactive ingredients lactose and uncharacterized urinary proteins (UUPs).
- In 1990, a predecessor to Ferring Pharmaceuticals Inc. (Ferring) submitted an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of Pergonal, called Repronex.
- Serono objected to the ANDA, arguing that Repronex's active ingredient FSH was not the "same as" Pergonal's due to natural variations in its molecular structure, known as isoforms.
- Serono also alleged that Repronex was different because it contained a different concentration of the inactive ingredient lactose and had different UUPs.
- The FDA determined that the isoform variations in FSH were not clinically significant and that both drugs' primary protein structures and potencies were the same.
- The FDA also concluded that the differing lactose concentration and UUP profiles in Repronex did not pose any safety concerns.
Procedural Posture:
- Serono filed a 'citizen petition' with the FDA in 1992, urging it to withhold approval of Ferring's generic drug.
- On January 30, 1997, the FDA approved Ferring's ANDA for Repronex.
- Serono sued the FDA in the U.S. District Court for the District of Columbia on May 30, 1997, seeking to rescind the approval.
- Serono moved for a preliminary injunction, and Ferring intervened as a defendant.
- The FDA formally denied Serono's citizen petition on June 17, 1997.
- On July 28, 1997, the district court (a trial court) granted Serono's motion for a preliminary injunction, finding Serono was likely to succeed on the merits.
- The FDA and Ferring, as appellants, appealed the district court's grant of the preliminary injunction to the U.S. Court of Appeals for the D.C. Circuit.
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Issue:
Does the Food and Drug Administration's (FDA) interpretation of the statutory requirement that a generic drug's active ingredients be the "same as" a pioneer drug's—an interpretation which permits minor, clinically insignificant variations in complex biological products—violate the Food, Drug, and Cosmetic Act?
Opinions:
Majority - Garland
No. The FDA's interpretation does not violate the Food, Drug, and Cosmetic Act. The FDA's construction of the term "same as" to mean clinically equivalent rather than requiring absolute chemical identity for complex biological drugs is a permissible interpretation of the statute and is entitled to deference. First, applying the Chevron framework, the court finds the statutory term "same as" is ambiguous because Congress did not define it. A strict interpretation requiring absolute chemical identity would be unworkable for complex biologics like menotropins, where natural variations exist even between different batches of the pioneer drug, and would frustrate the legislative intent of the Hatch-Waxman Amendments to facilitate generic drug approval. Second, the FDA's interpretation is reasonable. The agency required identity where possible (primary protein structure), controlled for natural variation to the same degree as the pioneer drug, and relied on scientific data to conclude the differences were not clinically significant. The FDA's policy of applying the regulations in effect at the time an application is filed (1990) rather than a stricter regulation enacted later (1992) was also reasonable and statutorily permitted. Because Serono has not shown a likelihood of success on the merits, and the other factors for a preliminary injunction do not favor Serono, the injunction is vacated.
Analysis:
This decision solidifies the principle of judicial deference to an administrative agency's scientific expertise under the Chevron framework. By allowing the FDA to define "sameness" in a practical, scientific context rather than as absolute chemical identity, the court opened the door for generic versions of more complex, naturally-derived biologic drugs. This precedent is significant because it prevents brand-name manufacturers from using minor, clinically irrelevant molecular differences to block generic competition, thereby advancing the cost-saving and public access goals of the Hatch-Waxman Amendments. The case instructs lower courts to avoid substituting their own scientific judgment for that of an expert agency when the agency's interpretation of an ambiguous statute is reasonable.
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