Bush Administration Doesn't Turn Over FDA Documents

February 12, 2008
Bush Administration Doesn't Turn Over FDA Documents

Feb. 12 (Bloomberg) -- The Bush administration failed to comply with a congressional subpoena seeking documents related to Sanofi-Aventis SA's antibiotic Ketek.

An investigative subcommittee of the House Energy and Commerce Committee sought briefing papers used to prepare Food and Drug Administration Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug in March. The administration's response was released today by the panel.

The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing. The commissioner and the FDA are under scrutiny from lawmakers who say the agency hasn't done enough to ensure the safety of Ketek and other medications. The subcommittee held a hearing today on Ketek, which has been linked to fatal side effects.

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.

Food and Drug Administration a "sorry mess"

July 17, 2007
Food and Drug Administration a "sorry mess"

In the wake of reports of contaminated food not only from China but also from domestic processors, the FDA's approach of relying on voluntary compliance "appears inadequate in responding to the changing food industry," said David Nelson, a senior investigator for the committee.

"FDA's ill-conceived decision to close seven of its 13 laboratories likely would expose American consumers to even more danger from unsafe foods, particularly imports," said Rep. Bart Stupak, D-Mich., chairman of the oversight subcommittee.

Criticism of the FDA was bipartisan. "The FDA must enter the 21st century," said Rep. Marsha Blackburn, R-Tenn.