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 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 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."
The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions to heparin, a blood thinner imported from China. An FDA investigation eventually concluded that the drug had been contaminated with an ingredient that mimics heparin to reduce costs. FDA inspectors were denied access to several facilities while investigating the issue.
The new legislation aims to prevent that from happening. Under the Senate bill, U.S. border agents would be able to turn away drug imports from companies that deny or delay FDA inspectors.
"These are all the steps American families already think we have in place to protect them," said Senator Michael Bennet, D-Colo., one of the authors of the bill. "I cannot tell you how many townhalls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected."
The House is working on companion bill similar to the Senate legislation. Lawmakers from both chambers will meet this summer to work out differences between the two versions. Congress must approve the bill before Oct. 1, when the previous FDA user fee program expires. After approval by Congress the bill must be signed by President Obama to become law.
Other key features of Thursday's legislation:
_ A provision aimed at reducing drug shortages requires all drugmakers to notify the government at least six months before discontinuing production of a drug. More than 280 drugs are currently in short supply, creating life-threatening delays for patients with cancer and other serious diseases. The shortages are driven by a number of economic factors, including consolidation in the pharmaceutical industry.
_ The bill would also increase the penalty for drug counterfeiting to up to $4 million, or 20 years in prison. Currently the penalty is a maximum $10,000 or three years in prison. This comes as incidents of counterfeiting reported by drugmakers have increased steadily over the decade to more than 1,700 worldwide last year. The FDA is currently investigating two batches of a fake cancer drug, Avastin that reached the U.S. earlier this year through European supply chains from the Middle East.
_ The legislation's underlying purpose is to renew, through 2017, a program under which drugmakers pay the FDA set fees for the agency to review new medications. Under the latest version of the program, generic drugmakers would pay review fees for the first time, adding $299 million per year in new revenue on top of the $693 million the agency stands to collect from branded drugmakers. The bill also renews a similar program for medical device reviews.
Lawmakers have granted three 5-year extensions to the program since its initial passage in 1992. Over the last 20 years, the Prescription Drug User Fee Act has allowed the FDA to hire hundreds of additional scientists to review drug applications in return for meeting certain performance goals.
Meanwhile, the Senate voted down several contentious amendments to the bill, including one which would have allowed Americans to import low-cost prescriptions from Canada. Importation has long been favored by seniors groups, including AARP, but opposed by the pharmaceutical industry, which would stand to lose sales. FDA regulators also oppose the idea, saying they cannot guarantee the safety of drugs overseen by Canada.
The vote on the amendment by Sen. John McCain, R-Ariz., was defeated by 54-43. Sixty votes were needed to prevail under a special rule.