WASHINGTON--(BUSINESS WIRE)--The following was issued by Freeh Group International Solutions:
Permitting prescription drug importation would lead to an increased flow of counterfeit and other potentially dangerous products across U.S. borders, worsen the opioid crisis, and cause unnecessary strain on law enforcement and already-overburdened government regulators, according to the findings of an investigation led by Former Federal Bureau of Investigation (FBI) Director Louis J. Freeh and released in a report today.
Commissioned by the Partnership for Safe Medicines, the “Report on the Potential Impact of Drug Importation Proposals on U.S. Law Enforcement” includes a series of recommendations to enhance existing law enforcement capabilities to address current threats to the nation’s drug supply that would be made worse by measures permitting drug importation.
“Every day, criminal enterprises that manufacture and distribute counterfeit medicines work diligently to prey upon innocent consumers,” said Judge Freeh. “The United States doesn’t have the luxury of opening up its drug supply. It isn’t a cost or partisan issue, but one that directly involves the safety and security of the American people. Law enforcement capabilities simply can’t keep pace with the expanded threat.”
As the report details, “The challenges facing law enforcement of taking down criminal enterprises involved in illicit drugs, insurance fraud, money laundering, and other criminal activities, would all be exacerbated by the opportunities created under an importation program.”
In conducting the investigation, Freeh Sporkin and Sullivan interviewed former law enforcement officials from the FBI, Food and Drug Administration (FDA), Drug Enforcement Administration, state and local law enforcement and industry security teams.
As noted in the report, interviewees cited drug importation as, “removing the last and potentially most critical line of defense of a closed prescription drug supply.” Other key findings include:
- Allowing drug importation would increase the financial incentives for individuals and criminal organizations to transship counterfeit and substandard medicines through Canada into the United States.
- Compounding an already-untenable opioid crisis, the U.S. market would be increasingly at risk for the smuggling of counterfeit opioids, including fentanyl, an extremely powerful opioid.
- Regulators and prosecutors would be overwhelmed with the burdens associated with adequately investigating and prosecuting a growing number of new cases of counterfeiting, diversion, and rogue websites creating by increasingly sophisticated criminal organizations.
The Freeh report includes a number of recommendations intended to strengthen existing law regulatory and enforcement capabilities to protect the security of the U.S. drug supply. They include:
- Assessing whether additional resources are needed by FDA, Customs and Border Protection (CBP), and the U.S. Postal Service to detect and deter drug counterfeiters and to strengthen current penalties and sentencing guidelines related to counterfeiting given the magnitude of the threat to public health.
- Given the increasing sophistication of criminal organizations involved in counterfeiting, expanding resources for “intelligence fusion centers” to facilitate the sharing of information on criminal organizations collected by federal law enforcement agencies.
- Enhancing CBP authority by passing legislation to address current gaps in inspection protocols to deter counterfeiters from using the U.S. postal service and reducing administrative burdens on CBP and FDA.
“Although the United States has one of the safest drug supplies in the world, it is not immune to the threat posed by international criminal organizations determined to market fake or counterfeit drugs in the U.S.,” said former Secretary-General of the International Police Organization (Interpol) Ronald Noble. “Drug importation proposals that permit wholesalers, patients, and pharmacies to import drugs directly into the U.S. would place many U.S. citizens at risk of purchasing or consuming counterfeit or adulterated drugs.”
“This investigation is among the most comprehensive assessments of law enforcement’s challenge with counterfeit medicines that I’ve seen in the last 15 years,” said Thomas Kubic, former Deputy Assistant Director of the FBI and President of the Pharmaceutical Security Institute. “It shows both the extent of the challenges and the opportunity for policymakers to address the gaps in our existing system. We need to be strengthening, not loosening, our defenses to ensure that patients in our country receive safe, effective medicines.”
A full copy of the report can be found here.
About Freeh Sporkin and Sullivan, LLP
Established by three former federal judges with decades of experience on the federal bench and at the highest levels of the U.S. government, Freeh Sporkin and Sullivan, LLP is a leading law firm that specializes in the areas of complex litigation-related issues and creative and practical crisis management solutions. The firm is unique in that it possesses team members with decades of experience on the federal bench and at the highest levels of the U.S. government, such as Judge Freeh’s service as the Director of the FBI. FSS has an extraordinary collection of talented and internationally recognized attorneys, with a broad range of bona-fides from the public and private sectors, who bring unparalleled expertise, reputation, judgment and immediate credibility to the selective legal representations the firm undertakes.
Freeh Group International Solutions, LLC (“FGIS”) is a global risk management firm serving in the areas of business integrity and compliance, safety and security, and investigations and due diligence. FGIS serves a diverse range of organizations in a cross section of industries, working to reduce risk in today’s increasingly dangerous and complicated global marketplace.
Note: The investigation was a joint effort between FGIS and Freeh Sporkin & Sullivan, LLP.