FDAnews Drug Daily Bulletin

CONSULTANT: HARMONIZATION COULD LEAD TO PRODUCT WITHDRAWALS

June 23, 2006
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The FDA's move to harmonize its approach to risk management with its European counterparts could prove too expensive for many pharmaceutical companies to handle, potentially leading some products to be withdrawn from the market, an industry consultant said.

The FDA's push to require further postmarket studies is an expensive trend that is making its way over to Europe, in part through the agency's efforts to harmonize risk management policies, John Poland, senior director for regulatory policy at Covance, said. Currently Europe does not require the same level of postmarket review that is required in the U.S.

Postmarket studies are "very large, very expensive programs," whose costs could change companies' minds about whether to keep a product on the market, he said during an FDANews audioconference June 13 on "Best Practices for Risk Management in the European Union."

The FDA is increasing its efforts to standardize its drug regulations with the European Union's, including risk management requirements. Recently, the agency recommended that the drug industry use International Conference on Harmonisation documents as a guide to manufacturing practices. This recommendation came after the agency withdrew seven guidances because they were inconsistent with its Pharmaceutical Current Good Manufacturing Practices for the 21st Century initiative.

But the cost of this trend could be the discontinued sale of products that, while effective, do not carry the "blockbuster" sales status that would outweigh additional postmarketing costs, Poland said. While companies are trying to reduce these costs, their efforts are not enough, he added.