Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

A judicial order to put one company's applications at FDA ahead of others would produce "no net gain" in the agency's attempt to handle its workload, the D.C. federal appellate court declared in an April 16 ruling against a suit by Barr Labs. Barr had petitioned the court to require FDA to grant or deny approval immediately to 23 of its pending ANDAs. The petition, originally filed in early 1990, was one of a broad array of legal actions and complaints to the agency from Barr to try to force faster action by FDA on its pending applications. D.C. Circuit Court Judges Silberman, Williams and Randolph stated that "though we agree with Barr that FDA's sluggish pace violates a statutory deadline, we conclude that this is not an appropriate case for equitable relief." In a writ of mandamus petition, Barr argued that FDA had violated the 180-day statutory timeframe for reviewing ANDAs. The company estimated that FDA averaged 336 days to process applications. The court agreed with Barr that FDA had missed a statutory deadline in its review of ANDAs. "The issue before us," the court said, "is not whether the FDA's sluggishness has violated a statutory mandate -- it has -- but whether we should exercise our equitable powers to enforce the deadline." The court rejected FDA arguments that the 180-day deadline for ANDA reviews is only "directory," or a "kind of policy recommendation." The court noted that "while judicial intervention could assist Barr, it would likely impose offsetting burdens on equally worthy generic drug producers, equally wronged by the agency's delay." The appellate court asserted that although the approval of Barr's applications might benefit consumers, the delay of other manufacturers' ANDAs would be to the detriment of consumers. "A judicial order putting Barr at the head of the queue simply moves all others back one space and produces no net gain," the decision states. "We have no reason to think that a judicial decree advancing one applicant would cure FDA's incompetence, if it exists and even if it is severe," the court said. "A court order could shift, but not lift, the burden that ineffciency inflicts on pharmaceutical suppliers and users." The court referred several times to FDA's sluggishness and inefficiency but implied that the situation should be changed by FDA's own procedures or congressional attention to the agency's resources. The court suggested that there "are probably remedies" (such as more resources or more efficiency) for FDA's slow processing of ANDAs, but "none is within our power" (see box for the court's encouragement for changes in FDA's ANDA review efforts). At the April 16 Furman Selz Fourth Annual Generic Drugs Conference in New York City, Barr President Edwin Cohen remarked: "We lost the battle but won the war." Cohen said the company feels "very comfortable" with the decision. "The court has joined the House Oversight Subcommittee and the U.S. attorney in vindicating Barr's assertion that the approval process has to be reformed," Barr said. The court stated that Barr might have had a case if it had "shown that FDA had singled it out for mistreatment; judicial relief would then advance the cause of equal treatment." The court noted that while Barr alleged that "FDA has vindictively singled it out for especially bad treatment" in a reply brief, the firm did not assert the claim initially. However, the court commented that "given the vague and secondhand character of Barr's claim (Barr emphasizes a lone congressman's suspicions)," the claim was probably not worthy of a special factual inquiry. The court deferred to FDA's prerogative in assigning tasks and budget allocations. FDA "is in a unique, and authoritative, position to view its projects as a whole, estimate the prospects for each, and allocate its resources in the optimal way," the judges asserted. "Such budget flexibility as Congress has allowed the agency is not for us to hijack," they said. "While Congress clearly intended a faster track for generic drug applications in general, it did not choose super-priority for Barr, and it did not address the trade-off between strict compliance with the 180-day deadline and the FDA's disposition of its other projects with enough clarity to guide judicial intervention." ANDA REVIEW INEFFICIENCIES: APPELLATE COURT URGES CONGRESS OR FDA TO ADDRESS PROBLEMS (Taken from the conclusion to an April 16, 1991 order from the D.C. federal appellate court. Paragraphing added by "The Pink Sheet.") Congress sought to get generic drugs into the hands of patients at reasonable prices -- fast. The record before us reflects a defeat of those hopes. There are probably remedies: more resources, more efficient use of those now committed, [and] elimination of the residual effects of the recently publicized scandals. For the reasons discussed, none is within our power, and a grant of Barr's petition is no remedy at all. For similar reasons, we see no point in maintaining constant supervision over the FDA's progress. We thus dismiss the suit, but invite Barr to refile should circumstances arise that would change the outcome of our analysis.

You may also be interested in...

User Fee Program Renewal Gets Trickier After Ruling In Omnitrope Court Case

Renewal of FDA's Prescription Drug User Fee Act could be complicated by a federal court ruling that the agency must take action on Sandoz' application for a follow-on version of Pfizer's recombinant human growth hormone Genotropin

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts