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April 26, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab’s president, and Russ McMahen, PFab’s vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (cGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

“Drug approval and CGMP compliance are part of the foundation of drug safety,” said Steven K. Galson, M.D., M.P.H, director of FDA’s Center for Drug Evaluation and Research (CDER). “When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively.”

PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.

The unapproved drugs manufactured by PharmaFab include, but are not limited to:

• De-Congestine Sustained Release Capsules;
• GFN 1200/DM 60/PSE 60 Extended-Release Tablets;
• Rhinacon A Tablets;
• Sudal 12 Chewable Tablets;
• Histex PD 12 Suspension;
• Atuss HX CIII;
• Ergotrate Tablets; and
• Hyoscyamine Sulfate Time-Release Capsules.

  Because these drugs have not undergone FDA approval, their safety and effectiveness have not been established, and FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

  According to the complaint filed with the court, PharmaFab did not comply with cGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with cGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.

  The consent decree requires the defendants to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain required FDA approval and fully comply with cGMP. If they resume distributing drugs, the defendants are required to retain an auditor to conduct inspections of their facilities for a period of five years and to provide reports to FDA analyzing compliance with cGMP and labeling requirements. The decree also allows FDA to require recall or shutdown in the event of future violations and provides for damages of $5,000 per day and $1,000 per violation, up to a maximum of $5 million per year, if the defendants fail to comply with its terms.

  “FDA will not hesitate to pursue enforcement action when necessary,” said Margaret O’K. Glavin, FDA’s associate commissioner for regulatory affairs. “We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs.”

  In June 2006, FDA issued a guidance document entitled “Marketed Unapproved Drugs–Compliance Policy Guide” (CPG). The CPG makes clear that firms may not market drugs that require approval without first establishing in applications that the products are safe and effective. One of the priorities in this CPG is enforcement actions against manufacturers that violate other provisions of the Federal Food, Drug, and Cosmetic Act.

  For more information:
  FDA’s ongoing efforts on marketing unapproved drugs
  www.fda.gov/cder/drug/unapproved_drugs

  CDER’s web page on Compliance with Current Good Manufacturing Practices
  www.fda.gov/cder/dmpq/