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PROVIDENCE—Sen. Catherine Cool Rumsey (Dist. 34—Charlestown, Exeter, Hopkinton, Richmond, West Greenwich) is among a number of state legislators who want to see greater accountability on the part of pharmaceutical companies regarding consumer knowledge. On May 6, the Rhode Island Senate passed a bill appealing to the U.S. Congress to require ‘country-of-origin’ labeling on consumer drugs.
“This bill informs the consumer where their drugs are being manufactured,” said Rumsey on the legislation. “This law is especially helpful to the consumer when drug companies may use foreign manufacturers because of lower prices or weaker drug safety standards.”
“People should have the information to help them make the best choices for the health and safety of their families,” she added.
The bill, sponsored by Senate Majority Leader Sen. Dominick Ruggiero (Dist. 4—Providence, North Providence), cites a 2011 report issued by the U.S. Food and Drug Administration (FDA) detailing the risks of using foreign ingredients from foreign manufacturers. In 2008, according to the report, 81 people were killed when a foreign manufacturer ‘substituted a fake ingredient’ into a supply of blood thinner, and many others developed illness as a result.
The ‘Pathway to Global Product Safety and Quality’ report further admits that the FDA will not ‘have the resources to keep pace with the pressures of globalization,’ although it has increased inspections of foreign drug manufacturers from 333 in 2007 to 424 in 2009. In 2001, states the report, six million shipments of FDA-regulated goods entered through U.S. ports of entry, while 10 years later that number quadrupled to 24 million shipments.
“Goods entering the U.S. will come from new and different markets, flowing through long, multi-step processes to convert globally-sources materials into finished goods,” read the report’s executive summary. “The shift in global product flows will make it difficult to identify the ‘source’ of a product and to ensure that all players along the supply chain meet their safety and quality.”
“According to the report, more than 80 percent of the active ingredients for drugs sold in the US are made abroad, often in plants that are rarely inspected,” said Rumsey.
The report further notes that the country’s reliance on imports will continue to grow, and rapidly. In 2000, for example, $1.7 billion worth in pharmaceutical products was imported into the United States. By 2008, that number increased to $18 billion.
“As supply chains become more global and complex,” read the report, “they will also carry an increasing number of complicated, high-risk products to the U.S. from abroad.”
“While a large portion of U.S. medical product imports have historically come from Western Europe, there are indications of a shift,” it continued. “Import lines from emerging markets, including Mexico, India, China, and Thailand, increased faster between 2002 and 2009 than lines from developed markets. China and India are each expected to see a more than 400 percent increase in their product exports between now and 2020.”
This shift in markets, as well as the increased risk of fraud and counterfeiting throughout the globe, will challenge the FDA in keeping foods and drugs safe for consumers. The FDA is currently implementing strategies by which food and drug manufacturing and transport networks can be more effectively monitored and scrutinized, particularly through partnerships with administrations from other countries throughout the globe.
The current legislation, passed by the Senate, will now be sent to the Rhode Island Congressional Delegation.
“Unless these companies of their own volition stop this potentially dangerous way of doing business, the best we can hope for is full transparency about the drugs that are being put on the market in the U.S.,” said Ruggiero in a statement.