Sanofi-Aventis U.S. LLC v. Food and Drug Administration
842 F. Supp. 2d 195
D.D.C.2012Background
- Sanofi sued FDA, alleging FDA exceeded authority under FDCA by requiring immunogenicity data for Sandoz's ANDA for enoxaparin and that FDA departed from precedent by approving before full characterization.
- FDA called for immunogenicity testing to assess potential immune responses and impurities related to purity under the ANDA framework.
- FDA adopted a five-pronged test to assess active ingredient sameness between Sandoz's enoxaparin and Lovenox, and relied on that framework to determine sameness.
- Sanofi challenged whether the ANDA pathway allows such testing and whether the evidence supported sameness, given enoxaparin’s partially characterized nature.
- The court held FDA acted within authority, did not depart from precedent, and, using deference to scientific judgments, found sameness supported and immunogenicity data appropriately required.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA had authority to require immunogenicity data in an ANDA | Sanofi argues 355(j)(2)(A) forbids extra data | FDA/Sandoz argue (j)(2)(A)(vi) and (b)(1)(D) authorize broad data | Yes, FDA authority is permissible under Chevron Step II/II; data allowed. |
| Whether FDA departed from agency precedent by approving before full characterization | Sanofi says FDA departed from precedent by not fully characterizing enoxaparin | Agency reasoned divergence warranted; adequate explanation given | No, agency acted with rational basis and within discretion. |
| Whether FDA's active ingredient sameness determination was supported by the five-pronged test | Sanofi disputes reliance on partial sequencing and five-pronged approach | FDA used overlapping criteria; deference due to agency expertise | Yes, five-pronged approach reasonably shows sameness. |
Key Cases Cited
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (deference to FDA; broad interpretation of information to satisfy requirements)
- Schering Corp. v. FDA, 51 F.3d 390 (3d Cir. 1995) (FDA expertise in determining safety/efficacy within its ambit)
- United Savings Ass'n of Tex. v. Timbers of Inwood Forest Assocs., 484 U.S. 365 (1988) (statutory interpretation context; reading statute in light of purpose)