White House Recommends New Legislation to Fight Counterfeit Drugs

On March 15, The White House issued legislative recommendations to Congress and advocated for increased vigilance in the fight against fake medicine.

Victoria Espinel, U.S. Intellectual Property Enforcement Coordinator, said on the White House blog that “we are seeking six legislative changes to fight counterfeits drugs, including increased criminal penalties for counterfeit drug offenses, particularly those that risk death or serious bodily injury.”

Referring to the recent 60 Minutes piece on fake drugs, she added, “We are aggressively going after this problem on multiple fronts, including by significantly increasing law enforcement efforts. In fact, health and safety seizures are up 97% from last year. And we are engaging with private sector companies on this issue as well– like Google, GoDaddy, Mastercard and other leading Internet companies that are setting up a nonprofit to fight illegal online pharmacies.”

The White House advocates increasing the sentencing guidelines for intellectual property offenses that risk death or serious bodily injury and for those offenses involving counterfeit drugs, even if the counterfeit drugs themselves are not deadly.

In addition, the White House is advocating five other legislative changes to improve U.S. efforts to fight counterfeit drugs:

1.“Require importers and manufacturers to notify the FDA and other relevant agencies when they discover counterfeit drugs, including the known potential health risks;

2.“Extend the Ryan Haight Act’s definition of “valid prescription” (and its telemedicine exemption) to the FFDCA to drugs that do not contain controlled substances;

3.“Adopt a track-and-trace system for pharmaceuticals and related products;

4.“Provide civil and criminal forfeiture under the FFDCA, particularly for counterfeit drug offenses;

5.“Increase the statutory maximum for drug offenses under the FFDCA, particularly for counterfeit drug offenses.”

Said Partnership for Safe Medicines Board of Directors’ member Dr. Marv Shepherd,“Yesterday’s announcement by Victoria Espinel, the U.S. Intellectual Property Enforcement Coordinator, is yet another example of the growing momentum in the United States to take action to curb the epidemic of fake drugs. This is a global public health problem that only continues to grow. While the United States is fortunate to have one of the safest drug supplies in the world, we cannot ignore the fact that this is a global market with suppliers, vendors, regulators and law enforcement located around the world.

“PSM commends the focus that the Administration and some in Congress have placed on combating counterfeit drugs as it is essential to this effort to ensure our country’s regulations, laws and policies are strong. At the same time, we must continue to work closely with our global colleagues so that the United States’ efforts are not just a finger in the dam,” continued Dr. Shepherd, who is also Director of the Center for Pharmacoeconomic Studies at the University of Texas-Austin.

“PSM and its partners applaud Ms. Espinel and her team, and look forward to working with them and other policymakers to lead a coordinated global fight to keep consumers safe from counterfeit medicines,” he concluded.

The full report prepared by the Counterfeit Pharmaceutical Inter-agency Working Group is available here.

By S. Imber