PHARMACY

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

BY Drew Buono

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.

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Amgen, Wyeth revise labeling for Enbrel

BY Drew Buono

PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.

The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.

Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.

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FDA approves Advair for wider use with COPD patients

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s asthma drug Advair to be used more widely to treat patients with chronic obstructive pulmonary disease, according to published reports. The drug had been approved to prevent wheezing and control other symptoms in COPD patients.

GSK’s approval comes the same day as rival AstraZeneca said it also was seeking FDA approval to sell its drug Symbicort for COPD.

COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.

The FDA’s approval allows GSK to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.

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