Congress Passes Bill Increasing Drug Inspections
WASHINGTON (AP) - A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. 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: It bolsters the agency’s budget with billions of dollars in drug industry fees for scientists who review new medicines. For the first time, generic drugmakers will pay review fees to speed the approval of their products. Branded drugmakers have paid those fees for 20 years.
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 fight 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 say 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 drop a requirement that FDA inspect all U.S. drug factories every two years and let it focus on foreign facilities, which it now typically inspects 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, or $4 million, from just three years or $10,000, under current law.
Despite months of negotiation, the bill does not include a national tracking system, which public health advocates say is critical to weeding out counterfeit pharmaceuticals from the U.S. supply chain. Lawmakers said they couldn’t bridge longtime disagreements between the FDA and drugmakers over the scope and cost of the system, which would track shipments using electronic codes.