Once again, several House Democrats have introduced a bill designed to increase funding and authority for the FDA to monitor drug production. The latest legislation, however, is aimed specifically at foreign-made pharmaceuticals, given ongoing concerns about the supply chain amid several episodes that questioned foreign production of meds sold in the US.
The new bill, which is called the Drug Safety Enhancement Act and was sponsored by John Dingell, a Michigan Democrat, and three of his colleagues, would provide added funding to the FDA to inspect drugs imported into the US, increase civil and criminal penalties, and increase agency inspection of overseas manufacturing to the same level of scrutiny applied to domestic facilities (to read the bill, please go here and type in HR 1483).
"For too long, Americans have suffered from unsafe pharmaceuticals coming into this country from foreign manufacturers and counterfeit drug operations," Dingell says in a statement released prior to a hearing yesterday that was held by House Energy and Commerce Subcommittee on Oversight and Investigation. "The Heparin crisis was a wakeup call that the FDA needs greater authority to stop unsafe pharmaceuticals and pharmaceutical ingredients from crossing our borders."
The hearing, by the way, underscored problems the FDA is having trying to launch an automated import examination software system known as PREDICT—the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting. There have been repeated delays for the past few years. So far, the system has been deployed in New York, Los Angeles, Seattle and San Francisco.
“FDA cannot claim to be doing all it can to protect the American people from these threats so long as such a major entry-point for goods into the country remains largely unmonitored," subcommittee chair Cliff Stearns told FDA commish Margaret Hamburg during the hearing (here are his remarks and you can watch the archived webcast here).
However, in her own testimony, Hamburg, noted the system will go online in Florida and San Juan, which would mean about half of all imports would be covered, and a national rollout will follow (background). "I am pleased to report that our nationwide rollout is back on track," she said, suggesting further deployment is imminent.