IOM proposes state, FDA actions to stop growth of counterfeit drugs

The Institute of Medicine Wednesday urged a series regulatory changes to help protect the public against buying fake or poorly made drugs.

Medpage Today: IOM: Work Needed On Counterfeit Drug Problem
State licensing boards should restrict their licensing activities to drug wholesalers who have been vetted by the National Association of Boards of Pharmacy (NABP) as a way of strengthening the nation's drug distribution system, the Institute of Medicine (IOM) said Wednesday. Also, FDA should establish a public database to share information on suspended or revoked wholesale licenses, the body suggested as part of its long list of recommendations. "Some states require NABP accreditation of wholesalers, but unscrupulous businesses can seek out states with lower standards for their headquarters," the IOM's "Countering the Problem of Falsified and Substandard Drugs" report stated. "And, because the wholesale trade is national, weaknesses in one state's system can become vulnerabilities in another" (Pittman, 2/13).

NPR: Report: Action Needed To Wipe Out Fake And Substandard Drugs
The National Academies of Science, of which the IOM is part, was commissioned by the Food and Drug Administration to look at how to protect people against fake and substandard drugs (Knox, 2/13).

The Wall Street Journal: More Lucrative Than Cocaine: Fake Medicine On The Rise
The risks of fake and flawed medicines have leapt from developing nations to Western supply chains, thanks to gaps in oversight of drug wholesalers, lax law enforcement, and ineffective tactics for tracking drugs as they change hands, according to a report released Wednesday by the Institute of Medicine. "It's distressing to see vividly just how huge a problem it is in the United States," said Larry Gostin, a Georgetown University law professor and World Health Organization adviser who led the study. "It's more lucrative to traffic in illegitimate drugs than cocaine or heroin," he said (Weaver, 2/13).

The Hill: Report: Fake Drugs Pose Threat To US
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. ... But members of Congress want to create legislation to increase the crackdown and oversight effort (Wilson, 2/13).