The Food and Drug Administration (FDA) says it has taken on the issue, already practicing the recommendations offered by the Institute of Medicine report, called “Countering the Problem of Falsified and Substandard Drugs,” including strengthening global regulatory capacity and drug manufacturing surveillance. The FDA sponsored the study.
“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,” wrote FDA Commissioner Margaret A. Hamburg in a statement on Wednesday.
But members of Congress want to create legislation to increase the crackdown and oversight effort.
Regulators, the Institution of Medicine wrote, might not be able to reach manufacturers of drugs that are falsely represented because the counterfeiters operate without a paper trail and are thereby difficult to prosecute or investigate. Further, being able to spot fake medications isn’t easy -- legitimate and illegitimate products often are indistinguishable and mix freely in unregulated markets, the report continues.
While the FDA said that it has a regulatory presence in 12 countries, the study found there could be vulnerabilities within its own borders.
For instance, the United States has thousands of secondary drug wholesalers “causing drug shortages and exploiting them for profit,” researchers say. While the report acknowledges that the National Association of Boards of Pharmacy requires criminal background checks and documentation of proper recordkeeping, drug storage and handling before issuing licenses, “unscrupulous businesses can seek out states with lower standards for their headquarters.”
In the report, the organization defines the term “counterfeit” as a medication that “infringes on a registered trademark.”