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

UsernamePublicRestriction
UsernamePublicRestriction

U.S. v. BARR: PRODUCT SAMPLE TESTING FAILURES CITED BY FDA

Executive Summary

U.S. v. BARR: PRODUCT SAMPLE TESTING FAILURES CITED BY FDA field investigator David Mulligan as one of the reasons the agency is seeking a temporary injunction against the generic drug firm from Newark, N.J. federal court Judge Alfred Wolin. Mulligan discussed sample testing failures uncovered by FDA investigators during inspections of Barr Labs during the last day of cross- examination Oct. 1. Barr Labs defense attorney Bruce Downey (Washington, D.C. office of Winston & Strawn) asked Mulligan why FDA wanted to recall Barr's aspirin with codeine. The FDA inspector replied that the product had failed content uniformity testing because one tablet of the initial 10 tested had failed by a wide margin. "It's the fact that you have the codeine at 64.8%, which is outside the 75%" content uniformity allowance, Mulligan said. The FDAer acknowledged that Barr had conducted tests on an additional 50 tablets, all of which were within specifications. However, he continued, the gross failure of the one tablet indicated a bad lot and made additional tests irrelevant. "And so from your point of view, even if Barr had tested another thousand tablets from this lot [and] all of them were within the 85 to 115 [percent specifications], because of this one tablet...you would say it couldn't be released. Is that your view?" Downey asked. "Yes," Mulligan replied. Sample testing failures are one point of dispute between FDA and Barr in the trial, which began Aug. 17. FDA is asking the court to order Barr Labs to cease production of 15 of its products, improve its production methods and process testing for 45 other products and recall 30 lots due to alleged problems with current Good Manufacturing Practices regulations. Barr challenged FDA claims of GMP violations that were not observed during inspections but were cited in the period since the agency filed suit against the company. Mulligan said during cross-examination that "since the second inspection" by FDA investigators last February-March, "we've received a lot of material in the litigation process...which has shown to us that the failure investigations have not included all systems, all situations." The FDAer told the court that a "graphic example would be the meclofenamate lots, where as much as two-fifths of a lot failed weight variation or were rejected, and there was no failure investigation at all." The trial concluded on Oct. 12, four days before scheduled. A decision in the trial is expected by mid-November. Judge Wolin, who has been trying to accelerate the pace of the trial due to a heavy autumn court schedule, informed both sides on Oct. 9 that he had heard enough testimony and gave Barr one final day to call additional witnesses. Barr was told to submit its affidavits on Oct. 14; the government must respond to those affidavits within one week. Final papers are due Oct. 23.

You may also be interested in...



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

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID005817

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel