FDA Gets Permanent Injunction Against Neilgen, Advent Pharmaceuticals for Selling Defective DrugsApr 13, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) just announced that it obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Maryland; its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, New Jersey; and two of the companies’ officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated, or misbranded drugs.
Neilgen, which also conducts business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are both contract manufacturers and distributors of over 25 different unapproved drug products each, said the FDA, which noted that the over 50 unapproved drug products primarily include prescription cough and cold products. The FDA provided the following list of unapproved drugs manufactured by Unigen and/or Advent and noted that the list might not be all-inclusive:
- RE All 12 Suspension
- BP Allergy Junior Suspension
- PE Tann 20 mg/CP Tann 4 mg Suspension
- BP New Allergy DM Suspension
- D-Tann CT Tablets
- B-Vex D Suspension
- Histex SR
- Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets
The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process; therefore, the unapproved drugs’ safety and efficacy has not been established by the agency. Likewise, the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the drugs’ labeling. The FDA is advising consumers in possession of any of these products to discontinue using them and to discuss FDA-approved treatments with their health care professional. Pharmacists should discontinue dispensing these products, as well, said the FDA.
The defendants signed a consent decree ordering them to destroy their existing drug supply, and prohibiting them from commercially manufacturing and distributing any new drugs without FDA approval. The firms must also retain outside experts to advise them on appropriate compliance standards with U.S. current Good Manufacturing Practice (cGMP) requirements for drugs, and obtain written authorization from the FDA to resume operations. The consent decree also authorizes the FDA to order the defendants to cease operations or take other corrective action in the event of future violations and further subjects the defendants to liquidate damages of $1,000 per violation; an additional $5,000 daily, up to $1 million annually, can be levied per violation, should the defendants fail to comply with any of the decree’s provisions, the FDA explained.
“The FDA's key enforcement priorities include shutting down manufacturers and distributors of unapproved drugs. Drugs not in compliance with cGMP cause great risk to public health,” said Michael Chappell, acting associate commissioner for the FDA's Office of Regulatory Affairs.
The FDA noted that it sought an injunction after the defendants failed to comply with previous warnings and continued to manufacture drugs in violation of federal law. Multiple FDA inspections of both facilities found the companies continued to manufacture unapproved new drugs and revealed numerous and recurring violations of the cGMP requirements for drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Both Unigen and Advent failed to respond adequately to issues raised by the FDA's inspection findings.