Spiller, Jr. Food and Drug Admin. Thomas E. Moseley, Lee H. Downey, Eric L. Hirschhorn, Cathy L. Burgess, Michael K. William C. Slattery, Megan E. Becker, Alan H.
Kaplan, Richard S. Currently before the Court is plaintiff's application for a preliminary injunction directing defendants to suspend, recall or revamp numerous products in their current product line.
On July 10, , the Court filed case management and protective orders. Beginning on August 17, , and continuing intermittently to October 12, , through the testimony of inspectors, experts and employees, the parties presented exhaustive but conflicting views of defendants' business practices. At the Court's direction, on October 26, , the parties submitted proposed findings of fact and conclusions of law. Each day with confidence and hope millions of people in the United States and other countries reach for pills, powders, capsules and syrups to relieve or prevent an infinite number of physical and mental ailments.
The weighty task of ensuring the integrity of these products, frequently unquestioned by most consumers, falls to the Food and Drug Administration, which monitors the practices of the drug industry through a system of approvals and investigations. Built into this maze of often ambiguous rules, however, is the recognition that drug manufacturers are businesses, which must follow efficient as well as effective procedures. The current conflict surrounding these rules is best characterized as a confrontation between a humorless warden and his uncooperative prisoner.
Exchanging heavy blows, the parties generated a record of more than twenty-three hundred pages of testimony, almost four hundred exhibits and numerous lengthy declarations. The plaintiff presented two witnesses, a government inspector, David Mulligan, and a regulatory expert, Dr. Robert Gerraughty. Defendants countered with a statistician, Dr. Sanford Bolton, their own regulatory expert, Dr.
Christopher Rhodes, an analytical chemist, Dr. Norman Atwater, an expert in pharmaceutical biology, Dr. Murray Cooper, and Barr employees.
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These witnesses revealed an industry mired in uncertainty and conflict, guided by vague regulations which produce tugs-of-war of varying intensity. The divergent views presented to the Court reflect not only a difference of perspective, but also the changes made at Barr Laboratories since the first threat of this litigation. As a result, the record is a composite of two trials: the case that was and the case that is. As such, the bases upon which some of the government's criticisms rest have disappeared during the course of this litigation.
Wary of this timing element, the Court has reviewed the lengthy record and the parties' proposed findings with the dual desire to protect an unsuspecting public and to avoid unnecessarily burdensome rules and now makes the following findings of fact and conclusions of law.
Defendant Barr Laboratories, Inc. Barr currently manufactures sixty drug products. Before this action was commenced, Barr voluntarily suspended the production and distribution of drug products pending further order of the Court. From until January 5, , defendant Edwin A. Defendant Gerald F. Price is Barr's Executive Vice President of Operations and is responsible for the performance of Barr's quality assurance department.
He has held this position since Defendant Ezzel-Din A. Hamza is Barr's Vice President of Technical Affairs and is responsible for regulatory affairs, research and development, and Barr's chemistry and microbiology laboratories. Under the Federal Food, Drug and Cosmetic Act the "Act" , a drug is adulterated if "the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
Parts and , sets the minimum standards for drug manufacturers. Designed as a quality control measure to prevent super- and sub-potency, product mix-ups, contamination, and mislabeling, ; Gerraughty , the CGMP regulations outline general rules for all aspects of drug manufacture including buildings and facilities, personnel, equipment, drug components and containers, production, packaging and labeling, and record-keeping.
Failure to comply with CGMP regulations renders any resulting drug product "adulterated" and the drug product and its producer subject to regulatory action. Congress recognizes the United States Pharmacopoeia "USP" , a nonprofit corporation which develops drug product standards with the help of professionals from academia, the medical community, the pharmaceutical industry and the FDA, as an official compendium. The USP supplements the CGMP provisions, specifying both the types of tests firms must perform and the range of acceptable results these tests must generate for releasing drug products.
These criteria, however, rest on the assumption that the products to which they apply satisfy CGMP.
William Barr Attorney General Confirmation Hearing Day 1
Ironically, the regulations themselves, whose broad and sometimes vague instructions allow conflicting, but plausible, views of the precise requirements, transform what might be a routine evaluation into an arduous task. To the extent that the regulations create ambiguities, the industry can turn for guidance to literature from seminars and pharmaceutical firms, textbooks, reference books and FDA letters to manufacturers, Gerraughty , or employ scientific judgment where appropriate.
The Court, however, cannot rely on industry practice alone to determine whether an individual firm meets the statutory requirements, since industry standards themselves must be reasonable and consistent with the spirit and intent of the CGMP regulations.
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FDA investigators conduct both pre-approval and general compliance inspections. FDA investigators conducted a general inspection of Barr's Northvale facility during August and September as well as separate general inspections of Barr's Northvale and Pomona facilities from May to September After each inspection, the investigators issued Forms The Form , which contained six general observations, cited Barr for unvalidated manufacturing and cleaning processes, the lack of failure investigations, incomplete annual reviews and failure to explain retesting.
United States v. Barr Laboratories, Inc., 812 F. Supp. 458 (D.N.J. 1993)
See Exhibit In the Pomona inspection, the FDA criticized nineteen products extensively and made general comments about Barr's equipment and complaint logs, stability programs, raw material controls and documentation procedures. See Exhibit 3. The Northvale inspection that same year also censured individual products as well as failure investigations, validation and product mix-ups.
See Exhibit 1. The resultant Forms listed seventy-five and forty-seven criticisms for Northvale and Pomona, respectively, many of which also had been recorded during prior visits to Barr, in the areas of process validation, failure investigations and laboratory practices. See Exhibits 2, 4. Testing lies at the heart of a drug manufacturer's successful operation.
Through testing companies validate their processes and ensure the quality of batches for release. As the Forms suggest, much of this current litigation stems from allegedly defective testing practices. With the mechanics of test-taking left undefined by the regulations, before discussing the specific allegations against Barr, the Court will outline the CGMP-required parameters which will guide its evaluation.
In the government's view, a batch failure occurs each time an individual test result does not meet the specifications outlined in the USP or the firm's ANDA.
In contrast, Barr does not classify initial out-of-specification results as batch failures. Instead, only after confirming out-of-specification results with additional testing, Bolton ; Cooper , pursuant to the firm's predetermined testing procedure, Cooper , would Barr conclude that a batch failed. Out-of-specification results obtained in the laboratory fall into three general categories: 1 laboratory error; 2 non-process-related or operator error; and 3 process-related or manufacturing error.
Laboratory error can result from an analyst's mistake or malfunctioning laboratory equipment. Examples of analyst error include mistakes in calculations, the use of incorrect standards for comparison, and simple mismeasurement. Those human and mechanical errors which occur during the manufacturing process cause nonprocess-related errors. For example, manufacturing equipment may malfunction or an operator may fail to add the proper amount of an active ingredient. In contrast, process-related problems, such as an incorrect mixing time, occur even though the workers and machines function properly.
Attorney General Confirmation Hearing, Day 1
As Inspector Mulligan acknowledged, all failures are not alike. An out-of-specification result identified as a laboratory error by a failure investigation or an outlier test, see Ex. Thus, the Court is unwilling to adopt the government's view of failure. Only with an investigation will a firm be able to identify the cause of an out-of-specification result. CGMP requires a thorough investigation following:. The government argues that an adequate failure investigation requires a timely, thorough, and well-documented review of the problem, which yields a written record containing: 1 the reason for the investigation; 2 a summation of process sequences that may have caused the problem; 3 the corrective actions necessary to save the batch and prevent recurrence; 4 a list of other batches and other products possibly affected along with their investigation results; and finally, 5 comments and signatures of production and quality control personnel regarding approval of any material reprocessed after additional testing.
Barr advocates a sliding-scale approach, claiming that the nature of the failure should govern the intensity of the investigation. In accordance with the CGMP-required for-cause failure investigation, Mulligan , the goal of every such inspection is to determine into which of the three failure categories the problem falls. The degree of inquiry required successfully to complete this task may vary with the object under investigation. As a result, a full investigation of the type the Government outlined always will not be necessary.
The issue of failure investigations first arises when testing produces a single out-of-specification result. Before proceeding to retest, Gerraughty , this unhappy occurrence must be met with a step-by-step review of the suspect laboratory tests.