Report: Fake drugs pose threat to US

The United States is not immune from the risks associated from substandard and knock-off medications, according to a new report by the Institute of Medicine.

While the risks are exponentially greater in developing countries, the report warns federal regulators that counterfeit drugs are a deadly reality in America as well. In the four months from September 2012 to January 2013, “negligent production” by a Massachusetts pharmacy sickened 600 people and killed 44, according to the Institute of Medicine of the National Academies. 

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.

“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,” said Rep. Henry Waxman (D-Calif.), the ranking member of the House Energy and Commerce Committee. “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.”

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.”

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