FDA Takes Yet More Enforcement Action on Marketed Unapproved Drugs; Reverses Course in a Drug-Based Action and Obtains Permanent Injunction in a Firm-Based Action

April 10, 2009

By Kurt R. Karst –      

We previously reported on FDA’s recent drug-based marketed unapproved drug enforcement action concerning certain narcotics.  In that case, FDA issued 9 Warning Letters to companies concerning 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone.  Late on April 9, 2009, FDA announced that the Agency will reverse course to allow the continued marketing and distribution of one of the drug products subject to its enforcement action – morphine sulfate oral solution, 20 mg/ml – on an interim basis due to concerns over a drug shortage.  According to FDA:

The FDA took this action in response to concerns from patients and health care professionals in the palliative care community that the action taken on March 30 would cause a shortage of 20 mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients. The agency has determined that this dosage form is medically necessary, and should remain on the market until an approved alternative becomes available to the patients that need it.

In another announcement made earlier today, FDA stated that the Agency obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. (which reportedly does business as Unigen Pharmaceuticals Inc.) of Westminster, Maryland, its parent company, Advent Pharmaceuticals, Inc., of East Windsor, New Jersey, and two of their officers, from manufacturing and distributing any unapproved, adulterated, or misbranded drugs.  The products subject to FDA’s enforcement action primarily include prescription cough/cold products.  According to FDA’s marketed unapproved drugs website, the Agency’s action against these companies and individuals is FDA’s 17th firm-based action since FDA issued its Compliance Policy Guide in June 2006.  FDA states in its announcement that:

The FDA 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 the Unigen and Advent facilities found that the companies continued to manufacture unapproved new drugs. FDA inspections also 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.