Township drug maker under FDA scrutiny

By: Dick Brinster
   EAST WINDSOR — A local pharmaceuticals manufacturer will have to prove to the U.S. Food and Drug Administration that it has corrected alleged violations, including the sale of unapproved prescription drugs, or face action as severe as seizure of its products.
   The company, Neil Laboratories, is a manufacturer of generic prescription drugs and over-the-counter medications such as painkillers and cold remedies.
   Neil has been told that it did not meet CGMP (current good manufacturing practice) standards in the production of 13 drugs and could be denied the right to produce them if corrections are not made, Ray Abrahams, director of the FDA’s compliance branch for the New Jersey district, told the Herald this week.
   In a letter May 31 to Neil Labs CEO Bharat Patel, the FDA detailed findings from an inspection of the lab facilities on Lake Drive from Dec. 13 to Dec. 28 of last year. The letter cited "significant CGMP deviations."
   The letter said Neil failed to establish scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.
   "Failure to correct these deviations and violations may result in additional regulatory action without further notice," the FDA said in the letter. "These actions include, but are not limited to, seizure of your products or injunction."
   The letter also said the company manufactured eight prescription drugs not approved for sale.
   "By introducing them into interstate commerce you are in violation," the warning said.
   Mr. Patel did not respond to messages seeking comment.
   Mr. Abrahams said he cannot comment on developments of an ongoing case but explained the agency’s follow-up procedure.
   "What usually happens is after a warning letter, we give the firm a period of time to take corrective action and then we reinspect," he said. "We haven’t done it yet, but we don’t announce inspections."
   The FDA also found fault with a lack of warnings for over-the-counter drugs.
   "Specifically, several aspirin products that you manufacture fail to bear the complete Reye’s syndrome warning and the specific pregnancy warning required for products that contain aspirin," the letter said.
   Reye’s syndrome is a disease which affects all organs of the body, but most lethally the liver and the brain, according to the National Reye’s Syndrome Foundation. It’s a two-phase illness because it is almost always is associated with a previous viral infection, such as influenza, cold or chicken pox.
   The warning letter is the most recent problem the company has encountered. Mr. Patel’s brother, Mantubhai Patel, the company’s former production manager was arrested when federal Drug Enforcement Administration agents raided the facility in 2002. Mantubhai Patel was charged with distribution for the purpose of manufacturing controlled substances.
   The raid was part a widespread probe of the diversion of chemicals for the manufacture of methamphetamine, according to the DEA Web site.
   DEA agents and diversions investigators searching the company seized multiple tons of ephedrine and pseudoephedrine along with 100 boxes of evidence and computer records. The Web site said ephedrine and pseudoephedrine are the essential ingredients in the illegal manufacture of methamphetamine, commonly known as speed.
   Neil filed suit later in 2002, charging that the DEA wrongfully suspended the firm’s registration to manufacture those chemicals, but the U.S. District Court for the District of Columbia upheld the government. The court said the DEA rationally concluded that Neil Laboratories posed an imminent danger to public health and safety.
   In February 2003, Neil reached agreement with the DEA to stop the manufacture of those drugs.
   Mantubhai Patel no longer works for Neil, according to a woman who answered the phone last week at the lab.