The FDA-sponsored study noted that regulators might not be able to reach counterfeiters because they operate without a paper trail and are thereby difficult to prosecute or investigate. And being able to spot fake medications isn’t easy, as legitimate and illegitimate products can be identical and mix freely in unregulated markets.
The United States has thousands of secondary drug wholesalers “causing drug shortages and exploiting them for profit,” researchers say. Although the National Association of Boards of Pharmacy requires criminal background checks and documentation of proper record-keeping, drug storage and handling before issuing licenses, “unscrupulous businesses can seek out states with lower standards for their headquarters.”
In a statement, Rep. Henry Waxman (R-Calif.), the ranking member of the House Energy and Commerce Committee, said that “this report reiterates what we have long known: the infiltration of our global supply chain with dangerous, illegitimate drugs is a serious public health problem. California has already passed a law to require individual units of drugs to be accounted for at each step along the supply chain. I hope we can pass a law at the federal level that provides the same level of protection as California’s model legislation.”
FDA Commissioner Margaret A. Hamburg issued a statement Wednesday, saying, “In order to meet the challenges of today’s global marketplace, the FDA is transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world."