Foreign drugs get little scrutiny by FDA

November 1, 2007
Foreign drugs get little scrutiny by FDA

Prescription drugs and drug ingredients pour into the United States from an estimated 3,000 foreign companies, though the real number is unknown and could be as high as 6,700, congressional inspectors said in a memo to members of the subcommittee ahead of Thursday's hearing. Among those invited to testify: FDA commissioner Dr. Andrew von Eschenbach. The agency declined an interview request ahead of the hearing.

The FDA plans to inspect just 300 foreign drug firms this year, announcing in advance its intent to do so each time. Of those inspections, most are of plants that make drugs awaiting FDA approval. Just 15 are of the type of periodic assessment meant to ensure a company's products remain safe in the years following FDA approval, though some pre-approval inspections also include some post-approval surveillance.