Alra Laboratories, Inc. v. Drug Enforcement Admin., 94-3585

Citation54 F.3d 450
Decision Date19 May 1995
Docket NumberNo. 94-3585,94-3585
PartiesALRA LABORATORIES, INC., Petitioner, v. DRUG ENFORCEMENT ADMINISTRATION, Respondent.
CourtUnited States Courts of Appeals. United States Court of Appeals (7th Circuit)

Steven M. Kowal, Richard O. Wood (argued), Burditt & Radzius, Chicago, IL, for Alra Laboratories.

Janet Reno, U.S. Atty. Gen., Philip Eric Urofsky (argued), U.S. Dept. of Justice, Narcotic & Dangerous Drug Section, Stephen H Green, Drug Enforcement Admin., Washington, DC, for Stephen H. Green.

Philip Eric Urofsky, Jo Ann Harris, Theresa VanVliet, U.S. Dept. of Justice, Narcotic & Dangerous Drug Section, Washington, DC, for Drug Enforcement Admin.

Before CUMMINGS, EASTERBROOK, and RIPPLE, Circuit Judges.

EASTERBROOK, Circuit Judge.

Between 1982 and 1989 Alra Laboratories held a license to manufacture and distribute "controlled substances"--principally drugs containing opiates or classed with them in the administrative pharmacopeia. Licensed firms must submit to periodic inspections to confirm their compliance with manufacturing and record-keeping rules. An inspection in 1990 revealed that Alra had neglected to apply for an extension of its license; by operating without a license, Alra violated innumerable statutes and regulations. The DEA seized Alra's inventory of 178,000 doses of clorazepate dipotassium, a Schedule IV controlled substance. Alra ceased making controlled substances (though it continued manufacturing other drugs) and applied for a new license. After an administrative process that lasted four years, the Drug Enforcement Administration said "no," 59 Fed.Reg. 50620 (Oct. 4, 1994), and Alra seeks review under 21 U.S.C. Sec. 877.

An evidentiary hearing on Alra's application revealed that the firm had long been out of compliance with the recordkeeping and reporting requirements applicable to manufacturers of controlled substances. In 1987 the DEA had issued a letter of admonition to Alra because of these problems and its failure to maintain effective controls against the diversion of regulated substances. During the 1990 inspection that revealed the firm's unlicensed status, the inspectors also found that Alra was improperly storing controlled and uncontrolled substances together. Alra had even more serious problems with statutes and regulations under acts administered by the Food and Drug Administration, which repeatedly had cited Alra for bad manufacturing practices and recordkeeping. Alra's entire inventory of prescription drugs was seized for forfeiture in March 1991, and a district court found them to be "adulterated" because of the presence of contaminants; Alra was out of operation until November 1991 (although it was permitted to "recondition" and sell most of the seized stock). Its troubles continue. In August 1993 Alra, its president and principal investor Baldev Raj Bhutani, and its corporate secretary Neelam Bhutani, were indicted for selling adulterated drugs, making false statements to the FDA, and attempting to obstruct justice by fabricating documents to throw the FDA off the scent and presenting false testimony to the grand...

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    • United States
    • U.S. District Court — District of Columbia
    • March 16, 2012
    ...to suspend was an on-going examination of the continued violations prior to and during the decision making process.”); cf. Alra Labs. Inc., 54 F.3d at 452 (“An agency rationally may conclude that past performance is the best predictor of future performance.”). 12 Second, the plaintiffs main......
  • Cardinal Health, Inc. v. Holder
    • United States
    • U.S. District Court — District of Columbia
    • March 7, 2012
    ...violations serve as a backdrop to the events that culminatedin the DEA's issuance of the Suspension Order.”); cf. Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). Cardinal also a......
  • John Doe, Inc. v. Drug Enforcement Admin.
    • United States
    • U.S. Court of Appeals — District of Columbia Circuit
    • April 27, 2007
    ...Fry v. DEA, 353 F.3d 1041, 1042-44 (9th Cir. 2003); Humphreys v. DEA, 96 F.3d 658, 659-60 (3d Cir.1996); Alra Labs., Inc. v. DEA, 54 F.3d 450, 451 (7th Cir.1995); Nutt v. DEA, 916 F.2d 202, 203 (5th Cir. 1990); Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 23 (D.C.Cir.1986). And, in th......
  • Jones Total Health Care Pharmacy, LLC v. Drug Enforcement Admin.
    • United States
    • U.S. Court of Appeals — Eleventh Circuit
    • January 29, 2018
    ...agency to consider whether the pharmacy will change its behavior in the future. MacKay , 664 F.3d at 820 ; Alra Labs., Inc. v. Drug Enf't Admin. , 54 F.3d 450, 452 (7th Cir. 1995) ("An agency rationally may conclude that past performance is the best predictor of future performance."). "[T]h......
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