New Jersey Drug Litigation Lawyers

FDA's New Jersey District Office Aims To Improve Drug Company Manufacturing

A PAT steering committee will oversee the development of a draft guidance to industry, which is expected to be ready by the end of August. In addition, CDER has invited industry to propose submissions using PAT technologies. Two companies have indicated they are interested in discussing their proposed submissions.

Members of the steering committee are: Douglas Ellsworth, who heads FDA's New Jersey District Office; Mike Olson, Ph.D., from FDA's Office of Regulatory Affairs; Joseph Famulare, director of the Division of Manufacturing and Product Quality in the Office of Compliance; Moheb Nasr, Ph.D., from the Office of Testing and Research in OPS; Frank Holcomb, Ph.D., Office of Generic Drugs in OPS; Yuan-yuan Chiu, Ph.D., director of the Office of New Drug Chemistry in OPS. Dr. Hussain is chairing the committee.

Already there are pharmaceutical manufacturing plants in Germany and Australia using various levels of the PAT process. "Although there are some plants in Germany using the process, I think the common understanding of PAT standards are uncertain throughout Europe at this point," Dr. Hussain said. "I anticipate that we will be able to define rigorous scientific standards quickly through the subcommittee process."

Dr. Woodcock said she sees two challenges facing the FDA regarding PAT. "I see our challenges as articulating guidances and addressing existing but 'hidden' problems in the current process that may surface as new technologies are introduced," she said.

The idea that using PAT will uncover problems was put in perspective by David Horowitz, the director of CDER's Office of Compliance. "We'll also find more solutions to problems, which will preclude regulatory action," he said.

Another challenge for CDER will be to recruit and train a scientific workforce proficient in the new technologies. Dr. Hussain envisions an interdisciplinary program with at least four areas: pharmaceutics, analytical chemistry, chemical engineering and information science.

Dr. Hussain said CDER needs to move PAT forward to counter industry perceptions that regulation is a roadblock. "I'd like to see us become the leaders in the application of this technology to improve the efficiency and quality of drug manufacturing processes," Dr. Hussain said.

Firm signs consent, agrees to record $500 million fine
FDA announced on May 17 that Schering-Plough Corp., its subsidiary Schering-Plough Products, LLC, and two principal corporate officers have signed a consent decree of permanent injunction agreeing to measures to assure that the drug products manufactured at the firms' New Jersey and Puerto Rico plants are made in compliance with FDA's current good manufacturing practice regulations. The firms will pay a record $500 million, the highest monetary settlement in FDA history.

The government's action in this case followed 13 inspections at four New Jersey and Puerto Rico facilities since 1998 during which FDA found significant violations of the CGMP regulations related to facilities, manufacturing, quality assurance, equipment, laboratories and packaging and labeling.

"This action is another clear sign that FDA will continue to enforce the rules and regulations requiring companies to carefully control and monitor their processes used to make pharmaceuticals and other products, so that those products will be safe and effective," said FDA Deputy Commissioner Lester M. Crawford, DVM, Ph.D. "Manufacturers who choose to wait until FDA investigators find violations rather than policing themselves will find that they have made a poor and costly decision."

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