WASHINGTON —U.S. regulators would inspect more drug-manufacturing facilities in China, India and other foreign countries as part of legislation approved Thursday that aims to step up oversight of the nation’s imported pharmaceutical supply.
The Senate bill, approved by an overwhelming 96-1 vote, addresses a number of concerns about the safety and quality of imported medicines. It also gives regulators new tools to combat drug counterfeiting and shortages.
The legislation represents a major shift in how the government oversees the pharmaceutical industry. For more than 70 years, the Food and Drug Administration has focused its inspections on U.S. factories. But over time, most companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008, the number of U.S. drugs made outside of the country doubled, according to FDA figures. Today, roughly 80 percent of the ingredients used in U.S. medicines are made overseas.
The Senate bill would do away with a requirement that the FDA inspect all U.S. factories every two years, and give the agency more discretion to focus on foreign facilities. Currently, the FDA inspects the average foreign manufacturing facility just once every nine years.
Under the bill, FDA inspectors would be instructed to target the most problematic manufacturing sites, regardless of location.
“This puts domestic and international facilities on an even playing field for the first time,” said Allen Coukell of the Pew Charitable Trusts, which has advocated for increased drug safety. “It says to FDA, ‘You should inspect the highest-risk facilities first, no matter where they are in the world.’ “
A look at the bill
Here are some of the key changes proposed by the bill:
Breakthrough drugs: Allows the FDA to speed up the approval of drugs that appear to have breakthrough potential by relaxing certain requirements.
Outside inspectors: Allows drugmakers to hire nongovernment inspectors to visit factories and assess whether they are meeting U.S. quality standards.
Device approvals: The FDA would be required to provide a rationale for denying clearance of low-risk medical implants within 30 days of issuing a rejection.
