Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved Drugs

April 20, 2010

By Kurt R. Karst –   

In recent weeks, two advocacy groups have sent letters to FDA requesting that the Agency enhance and accelerate its enforcement activities with respect to marketed unapproved drugs.  FDA began its current Unapproved Drugs Initiative in June 2006 when the Agency published a compliance policy guide explaining the Agency’s risk-based enforcement policy.  Under this approach, FDA gives higher priority to enforcement action against unapproved drugs in the following categories:

  • drugs with potential safety risks;
  • drugs that lack evidence of effectiveness;
  • drugs that present a “health fraud”;
  • drugs that present direct challenges to the new drug approval and OTC drug monograph systems;
  • unapproved new drugs that are also violative of the FDC Act in other ways (e.g., Current Good Manufacturing Practice regulation violations); and
  • drugs that are reformulated to evade an FDA enforcement action (e.g., when a firm, in anticipation of FDA enforcement action, changes its unapproved drug product by, for example, adding an active ingredient, in an attempt to evade such enforcement action).

Since June 2006, FDA has taken scores of enforcement actions affecting hundreds of drug products.  And, as we previously reported, along the way, FDA has begun using new mechanisms, such as drug listing information, to guide enforcement activity.

The National Minority Quality Forum (“NMQF”), a “research and educational organization dedicated to ensuring that high-risk racial and ethnic populations and communities receive optimal health care,” recently announced that the organization sent a letter to FDA expressing concern that marketed unapproved drugs “may compromise the health of patients, and create increased liability for the physicians who prescribe them” and requesting that FDA enhance its enforcement of the Agency’s Unapproved Drugs Initiative.  To support FDA’s enhanced enforcement, NMQF also announced that it is launching a public information campaign called “Did You Know?”  The campaign is intended to “serve as an educational resource to consumers, physicians and policymakers who want to learn more about risks associated with unapproved drugs in the marketplace.”

Another advocacy group, MANA, a self-described national Latina organization, has also joined the fray and has asked FDA to accelerate its efforts to remove unapproved drugs from the marketplace.  According to MANA’s letter, “removal of all unapproved drugs from the marketplace is an important and commendable goal that must be achieved as soon as possible.  Doing so will not only encourage other companies to pursue the proper measures necessary to win FDA approval for their own products, but more importantly, will assure that no more unnecessary harm is brought to the unknowing purchasers of unapproved drugs in this country.”  MANA is also concerned that “even well-meaning physicians continue to write scripts for unapproved drugs falsely characterizing these drugs as ‘generics’ and leaving the patients they care for at risk.”  MANA offers its assistance to FDA to accelerate the removal of marketed unapproved drugs, but the organization’s letter offers no details on what assistance MANA could provide to FDA to achieve this goal.