In the wake of the scandal over Heparin and the failure of the FDA to inspect the Chinese plant that supplied the active ingredient for the blood thinner, the House Energy and Commerce Committee has sent a letter to Mike Leavitt, the Health and Human Services Secretary, suggesting emergency legislation may be in the cards to “protect Americans from prescription medications that have been insufficiently investigated prior to approval.”

“These Heparin tragedies are likely the result of FDA abandoning its preapproval inspection requirement, a critical policy was put in place two decades ago after a generic drug investigation by this Committee,” Dingell says in a statement. “This requirement was designed to protect consumers by ensuring that drug manufacturers operated appropriately and safely. Since it appears that FDA feels free to ignore this long-standing policy, we are now considering whether such safeguard should be codified into law.”

Last Friday, committee staffers interviewed FDA officials about the agency’s policy toward inspections prior to a drug’s approval. Earlier this week, FDA officials insisted that agency policy is to inspect all facilities that are named in applications for drugs for which marketing approval is sought in the US. However, Dingell - along with Bart Stupak - apparently aren’t sure whether to believe them, as a letter to FDA commish Andy von Eschenbach clearly indicates…

“We were…informed that FDA is under no obligation to withhold approval or otherwise bar shipment until such an inspection is completed. Most importantly, your staff advised that selling a drug product from a plant that has never undergone a pre-approval inspection does not constitute the distribution of an unapproved drug… For a drug to be eligible for approval by FDA, it has been the understanding of Congress that the agency must approve each step of drug manufacturing, including all ingredient sources…

“Preapproval inspections were designed to assure that drug manufacturers would never again be able to gain FDA approval by asserting that drugs would be produced pursuant to a valid manufacturing process and with qualified suppliers of ingredients when the facility was incapable of manufacturing the drugs as specified. Apparently, FDA has deliberately failed to apply this inspection policy to drug manufacturers in China.”