WASHINGTON (AP) — A Food and Drug Administration bill designed to increase inspections of foreign drug manufacturing sites, while also speeding up approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the Senate.
The Senate approved the must-pass piece of the legislation by a vote of 92-4, and President Barack Obama is expected to sign it into law within days.
The core of the bill is critical to the FDA because it bolsters the agency’s budget with billions of dollars in drug industry fees, which the government uses to hire additional scientists to review new medicines.
But lawmakers seized on the legislation to address recent concerns about the safety and quality of prescription medicines, especially those that are imported. The bill also gives the FDA new tools to combat drug counterfeiting and drug shortages, which have made headlines in the past year.
“This legislation will help bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs,” said Sens. Tom Harkin, D-Iowa, and Mike Enzi, R-Wyoming, who guided the bill through the Senate.
Public health experts said the most significant changes for consumers involve how FDA inspectors oversee foreign drug manufacturing facilities.
For more than 70 years, the agency has focused its inspections on U.S. factories. But 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 FDA figures.
The bill passed by Congress would do away with a requirement that 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 every nine years. The new bill requires that FDA inspectors target the most problematic manufacturing sites, regardless of whether they’re in the U.S. or overseas.
“This legislation will, for the first time, enable the FDA to regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications,” said Allan Coukell, director of the Pew Charitable Trusts’ medical programs
The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions — some fatal — to a blood thinner imported from China. An FDA investigation concluded the drug had been contaminated, to reduce costs, with an ingredient that mimics the blood thinner heparin.
The bill would raise the maximum prison sentence for drug counterfeiting to 20 years. The maximum now is three years.
Despite months of negotiation, the bill does not include a national tracking system, which public health advocates say is critical to weeding counterfeit pharmaceuticals from the U.S. supply chain. Lawmakers said they were unable to bridge longtime disagreements between the FDA and drugmakers over the scope and cost of the system, which would track drug shipments from factory to pharmacy using electronic barcodes or tags.