If the Senate approves the FDA reauthorization bill this week, the agency would be in line to get more money and more authority to inspect manufacturing plants around the world where 80% of the ingredients used in drugs now originate.
The new bill does many things, including getting drugmakers, both branded and generic, to contribute more in user fees, but for many, the big deal in the bill is the leverage it gives the agency to inspect the manufacturing plants of foreign companies, or to block their products if they refuse, The Wall Street Journal reports. It also puts the responsibility on drug manufacturers to audit their suppliers to insure that their APIs meet U.S. standards. The consequences of not doing that became apparent several years ago when tainted heparin sourced in China was linked with 81 deaths here. China has stepped up oversight but it is generally acknowledged that the Chinese regulator has difficulty keeping on top of the safety issues there.
Right now, U.S. plants are inspected at least every two years, while foreign plants are inspected only every 9 years, on average, WSJ points out. Under the reauthorization bill, the FDA could address that disparity by having the authority to put its attention to whatever products appear to present the most risk.
Still, with the explosion in global API and pharmaceutical manufacturing, the FDA will be hard pressed to keep up. To help, the agency has been creating a new program with some of the biggest regulatory agencies around the world, to share resources and information, even providing a funding mechanism to pay one agency to inspect plants for another.
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