Some criticism drawn over FDA authority bill

WASHINGTON Following a hearing late last week on a draft bill intended to enhance the Food and Drug Administration’s authority, which saw industry and bipartisan political support, a number of the draft’s provisions drew criticism.

The draft bill—sponsored by House Energy and Commerce Committee chairman John Dingell, D-Mich., Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations Subcommittee, and Rep. Frank Pallone, D-N.J., chairman of the Health Subcommittee—is aimed at preventing imports of unsafe products such as the tainted heparin linked to 81 deaths in the U.S. due to contamination of its active pharmaceutical ingredient at a Chinese plant.

The draft would give the FDA additional authority to order mandatory recalls, refuse entry of drugs made in foreign plants that do not cooperate with FDA inspections and destroy adulterated or misbranded drugs at ports of entry, all of which produced general agreement.

But the draft’s requirement that the FDA inspect all overseas drug-manufacturing plants once every two years instead of continuing its current risk-based approach drew fire. While agreeing that more overseas inspections are needed, ranking member Joe Barton, R-Texas, said, “We do not need to waste more resources by scheduling mandatory inspections at specific times.” He also charged that the Republican minority had no input into the draft bill.

The prospect of a track-and-trace requirement, which is not in the draft, drew resistance from the National Association of Chain Drug Stores, whose vice president for pharmacy regulatory affairs, Kevin Nicholson, argued that the technologies necessary to make track-and-trace work, such as radio-frequency identification tags on individual pill bottles, “need to be properly road-tested and the bugs worked out before any statutory mandates for their use.”