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NATIONAL PHARMACEUTICAL ALLIANCE v. HENNEY

Civil Action No. 99-0394 (JR).

47 F.Supp.2d 37 (1999)

NATIONAL PHARMACEUTICAL ALLIANCE, et al., Plaintiffs, v. Jane E. HENNEY, Commissioner, U.S. Food and Drug Administration, et al., Defendants Pharmaceutical Research and Manufacturers of America, Defendant-Intervenor.

United States District Court, District of Columbia.

April 20, 1999.

Attorney(s) appearing for the Case

Daniel G. Jarcho, McKenna & Cuneo, L.L.P., Washington, DC, for plaintiff.

Gerald Kell, Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, for defendants.

Bruce N. Kuhlik, Michael S. Labson, Mark E. Porada, Covington & Burling, Washington, DC, defendant-intervenor

Mark J. Larson, Hogan & Hartson, L.L.P., Washington, DC, for American Academy of Pediatrics.

MEMORANDUM

ROBERTSON, District Judge.

The Food and Drug Administration Modernization Act of 1997 (FDAMA), codified as 21 U.S.C. § 355a, provides a 6-month extension of the statutory market exclusivity given to a new drug if, upon FDA's request, the manufacturer studies the effect of the drug on children. The plaintiffs in this case, two trade associations of generic drug manufacturers, complain that FDAMA is being misapplied. They seek to enjoin...

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