Congress Hammers FDA on Preapproval Inspections Policy
House Democrats are questioning the FDA’s view that conducting preapproval inspections is a matter of policy rather than a statutory requirement.
The issue stems from the FDA’s admission that it did not conduct a preapproval inspection of a Chinese facility producing the active pharmaceutical ingredient (API) for Baxter’s injectable blood-thinner heparin. Baxter recalled the drug after a spike in reported adverse events were observed — primarily serious allergic reactions, incidents of hypotension and patient deaths.
The agency subsequently inspected the facility, Changzhou SPL, and cited the operation for 11 FDA Form 483 observations, including the use of raw material from an unacceptable vendor.
According to a letter sent to FDA Commissioner Andrew von Eschenbach in February from Energy and Commerce Committee Chairman John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.), chairman of the Oversight and Investigations Subcommittee, the agency told committee staff that it was not required to conduct an inspection before approving a drug.
In a separate letter to HHS Secretary Mike Leavitt, the lawmakers request information to help determine if emergency legislation is needed “to protect Americans from prescription medications that have been insufficiently investigated prior to approval.” They also want to know if the FDA has altered its policy on inspecting manufacturing facilities before approving products.