Industry trade groups signal willingness to support a new user-fee system

WASHINGTON Three major pharmaceutical trade groups—Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Biotechnology Industry Organization—told federal lawmakers they may be willing to support new fees in order to give the Food and Drug Administration the resources it needs to significantly expand inspections overseas, according to published reports.

The three trade groups yesterday said Congress should appropriate more money for the inspection program, but also said the industry is willing to discuss a new user fee system, within limits. Issues raised by the associations included the size of the fees; commitments that the funds will be focused on higher-risk overseas manufacturers; and assurances the system will not result in hindering the timely availability of pharmaceuticals in the U.S. market.

Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce health subcommittee, said he was “pleased that the industry, pharmaceutical companies, biologics companies and generic companies have been willing to cooperate and assist us in our endeavors.”

A legislative proposal sponsored by Rep. John Dingell, D-Mich., would impose an annual fee for all domestic and foreign drug producers to pay the costs of plant inspections. Foreign drug producers would have to be inspected every two years like domestic manufacturers, a requirement that now does not exist.

Pallone said the bill, still in draft form, would also establish stronger enforcement, testing and registration systems for foreign suppliers.

Many generic and brand name drugmakers manufacture medicines overseas or import drugs and ingredients that are made in countries where the regulatory environments are weak. The problem has been highlighted by the disclosure of raw ingredients from China used in the blood-thinner heparin that have been linked to the deaths of 81 Americans.

An estimated four out of 10 prescription drugs sold in the U.S. are manufactured abroad, and about 80 percent of the active pharmaceutical ingredients used by U.S. manufacturers to make prescription drugs are imported.