FDA officials and industry leaders are calling for more concerted efforts to address these decades-old problems, aggravated by increased globalization in drug production and sourcing, added pressure on industry to cut costs, and more intense public scrutiny of drug quality and safety. The deteriorating situation threatens to erode manufacturer revenues, as well as public confidence in the pharmaceutical industry and in FDA's ability to protect patients.
Manufacturers are stepping up efforts to secure supply chains, tighten security protocols, and prosecute criminals. Pfizer (New York) has been working with federal enforcement agencies to stem widespread counterfeiting of Viagra (sildenafil), while GlaxoSmithKline (London) seeks to halt e-Bay auctions of counterfeit versions of the weight-loss drug Alli (orlistat).A recent Pfizer research report, "Cracking Counterfeit Europe," describes a $14-billion black market for counterfeit medicines in Europe and estimates that 50-90% of drugs purchased online by Europeans are fake and often contain too little active ingredient. The problem is much more serious in developing nations; the United Nations calculates that more than $500 billion in counterfeit drugs is traded each year throughout the world, leading to approximately 700,000 deaths annually from malaria and tuberculosis.
One response is to expand FDA's oversight of imports and to strengthen drug pedigree requirements. The US received approximately 20 million shipments of food, devices, drugs, and cosmetics in 2009, up from about 6 million a decade ago. Some 40% of the drugs taken by Americans are imported, and about 80% of active pharmaceutical ingredients come from overseas. "Globalization has fundamentally altered our market landscape," stated FDA Commissioner Margaret Hamburg at the Center for Strategic and International Studies in February. Addressing global supply-chain safety "is one of my highest priorities for FDA," she asserted.
However, Hamburg and others acknowledge that FDA has the capacity to inspect only a tiny fraction of imports and less than 8% of foreign drug-manufacturing establishments each year. The agency has established offices in China, India, and other regions to increase its presence around the world. These outposts are building regulatory capacity in other countries and supporting collaboration on regulatory issues, but are not equipped to do much on-the-ground oversight.
Thus, FDA has launched the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information system to target its oversight of imports on the riskiest food and drug products. PREDICT ranks import shipments based on the nature of the product and past compliance experience of a producer or shipper, among other factors. Products with high risk scores will be targeted for inspection, while low-risk items will move though customs more rapidly. FDA is implementing PREDICT first for foods and examining what changes may be needed for it to work for drugs.
The agency also proposed a Secure Supply Chain Pilot project to provide "green lane" processing for drug imports from shippers and manufacturers with secure supply chains. Although announced a year and a half ago, the pilot has not yet begun because of details that need to be worked out with the US Customs and Border Protection (CBP) agency. One issue is whether drugs and medical products can use CBP's Customs-Trade Partnership Against Terrorism (C-TPAT) program, which offers reduced border inspections and priority processing for products from companies with validated security practices and fully controlled global supply chains.
In addition, FDA officials would like Congress to enhance its authority to detain and destroy illegally imported food and drug products. The House of Representatives approved food-import safety legislation last November, but the bill has been stuck in the Senate for several months, largely because of legislators' focus on healthcare reform. The food-safety measure was pulled out of the broader FDA Globalization Act sponsored by Rep. John Dingell (D-MI), which also increases FDA authority to deal with an increasingly global drug supply. Once the food safety measure is enacted, Congressional leaders say they will take up the drug-import provisions. But recent efforts to add to the legislation a ban on bisphenol-A in food containers has drawn strong opposition from the food industry and raised uncertainty about the bill's future.
At a PDA/FDA Pharmaceutical Supply Chain Workshop in Bethesda, Maryland, in April, Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), emphasized the need to update FDA authority over imports. Under current law, FDA has to demonstrate that a product is adulterated or counterfeit to block its entry. "That's backwards," Autor said, explaining that importers should have to demonstrate that a drug is safe to bring it into the country.
Ironically, efforts to reduce the import of counterfeit and adulterated medical products could be undermined by federal and state policies that permit reimportation of low-cost drugs from other countries. Sen. Byron Dorgan (D-SD) and Montana Governor Brian Schweitzer have requested federal permission to import drugs from Canada for these two northwestern states, but FDA maintains that such a program could facilitate drug diversion and counterfeiting. At a Senate budget hearing in March, Commissioner Hamburg told Sen. Dorgan that drugs imported outside the regulated supply chain raise "genuine safety concerns," particularly for products ordered over the Internet. FDA officials note that drugs supposedly imported from Canada frequently come from other parts of the world, and that many medicines ordered through pharmacy websites are counterfeit or substandard. But many politicians and consumers regard theses claims as mere ploys by the pharmaceutical industry to keep out cheaper competition.