US FDA Reform Bills Slammed By Commissioner

Pending legislation to reform the US Food and Drug Administration would jeopardize safety, FDA Commissioner David Kessler has told the House Subcommittee on Health, adding that he hoped a compromise could be reached. The panel was hearing statements on the three FDA reform bills pending in the House.

The various bills would do little to speed new products to patients, Dr Kessler told the four-hour hearing, but would "undermine our ability to protect American citizens from unsafe and ineffective products." However, he felt "there is a middle ground." In the past few years, the FDA has accelerated approval processes so that it now approves new drugs and devices as fast as any other country, he noted, but expressed his concern "about going any further."

Outside Reviews "Troublesome" A major feature of the three bills is the streamlining of the approval process for drugs, veterinary drugs and medical devices through the use of outside parties to review applications. The agency, said Dr Kessler, finds this practice "extremely troublesome." The provision would allow manufacturers to pay third parties certified by the agency to review their new products, with the third parties sending their recommendations to the agency for a final decision. Dr Kessler questioned how the third parties could remain independent when future contracts might depend on favorable findings. Broad privatizations will not get safe and effective products onto the market, he said.