June 9, 2006

The FDA's efforts to eliminate unapproved drugs from the market is more show than substance and seems to be part of an agency trend to tread lightly where industry is involved, an activist group says. But a former FDA official disagrees, arguing that the agency's announcement shows a new dedication to ending the practice.

The agency issued its guidance, Marketed Unapproved Drugs -- Compliance Policy Guide, with the intent of putting industry on notice that the FDA is serious about enforcing the regulations against companies that market drugs without getting agency approval. Unapproved drugs are a "significant and serious drug safety issue that must be addressed," Steven Galson, director of the agency's Center for Drug Evaluation and Research, said during a teleconference announcing the guide.

But this announcement is just "a show" that does not represent a real change in agency policy, Peter Lurie, the deputy director of Public Citizen's Health Research Group, told FDAnews. The group has been asking the FDA to change its policies on unapproved drugs since 1996 to no avail, he said.

The guidance only requests that companies voluntarily provide information on these drugs and submit new drug applications; it does not force them to act, Lurie said. The agency is being "naive" in thinking a mostly voluntary approach will be enough, he said. FDA is working under the "hope that a general fear [of possible enforcement] will cause the industry to do something."

But Marc Scheineson, a partner at the Washington, D.C., law firm Alston & Bird and former FDA associate commissioner for legislative affairs, responds that the agency is in fact "throwing down the gauntlet" to industry by finalizing this guidance. When the FDA first introduced the guidance in 2003, it faced tremendous political pressure from lobbyists representing unapproved manufacturers and some in Congress.

These opponents argued that the guidance was unnecessary. Finalizing the guidance and announcing its intent to enforce against some manufacturers is the FDA saying it "won't be intimidated politically," Scheineson added. But he acknowledged that the question remains whether the agency will aggressively enforce this policy. "Will they put their resources where their mouth is?" he asked.

The FDA also does not plan to recall any drugs that were on the shelves before the agency determines that they were being marketed illegally. This decision continues an agency trend of not going far enough to remove drugs from the market, even when there is a risk to public health, Lurie said. For example, the agency recently announced it would not recall supplies of Abbott Laboratories' attention deficit disorder drug Cylert, even though serious injuries have been associated with the drug. (http://www.fdanews.com/did/5_113/)