FDA Takes Enforcement Action Against Companies Marketing Unapproved Narcotic Drugs

March 31, 2009

By Kurt R. Karst –      

Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics.  The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone.  The Warning Letters direct the companies to stop manufacturing and distributing the specific narcotic drug products in certain dosage forms that lack FDA approval.  According to FDA, “[m]anufacturers have 60 days after the dates of the Warning Letters to cease manufacturing of new product, and distributors have 90 days after the dates of the Warning Letters to cease further shipment of existing products.”  (Of course, if the marketing of these products is illegal, that raises the question of why FDA would permit their continued manufacturing for 60 days.)

FDA’s action today is the first drug-based enforcement action the Agency has taken since September 2008, when FDA issued a Federal Register notice concerning unapproved ophthalmic drug products containing Balanced Salt Solution.  It is also the tenth drug-based enforcement action FDA has taken since June 2006 when the Agency announced its new unapproved drug initiative to remove unapproved drugs from the market and issued its final Compliance Policy Guide (“CPG”) on the topic.  FDA’s CPG articulates a risk-based enforcement approach under which the Agency gives higher priority to enforcement action against unapproved drugs in certain categories, including drugs with potential safety risks, drugs that lack evidence of effectiveness, drugs that present a health fraud, and drugs that present direct challenges to the “new drug” approval and over-the-counter drug monograph systems.  FDA’s decision to take enforcement action with respect to certain unapproved prescription narcotics aprears to be due, at least in part, to preserve the integrity of the drug approval process.

We recently reported on oxycodone shortages.  FDA also announced oxycodone shortages just a few days ago.  A couple of the firms noted on FDA’s oxycodone drug shortage list received Warning Letters.  It is unclear the extent to which FDA’s enforcement action might further concerns about drug product shortages.