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On Friday, four House members introduced important drug safety legislation aimed to better protect the drug supply through tightened import rules, inspection, tracking, and FDA resources.
The Drug Safety Enhancement Act builds off the FDA Globalization Act introduced last year, and sponsoring Reps. John Dingell, Henry Waxman, and Frank Pallone have pledged to work quickly in the next Congress to pass the bill.
Here’s what the bill does, according to Friday’s statement:
Why drug safety now? For those regular readers of PostScript, you know our take: a rising and record number of drug recalls last year, a borderless and increasingly splintered supply chain in which manufacturers may not know where their raw materials originated, much less how safe they are, and a semi-regulated global marketplace in which many players cut corners on quality control has injected a little too much guesswork into knowing how safe and effective our drugs are. The FDA has made big strides in the last several years to tighten up gaps in the supply chain, and the bill proposed last week would help the agency and industry go further.
For updates on drug safety legislation and news, follow SafeRxWatch on Twitter.
For summaries of previous drug safety legislation, a consumer survey on drug safety, and other resources, visit the Pew Prescription Project’s Securing a Safe Drug Supply.
–Kate Petersen, PostScript blogger