The United States is the leader in biopharmaceutical innovation and in guaranteeing that our prescription drugs are safe and effective. For decades, the Food and Drug Administration (FDA) has enforced a strict set of rules and protocols that allow Americans to have confidence in the drugs that they buy. Other countries do not have the same rigorous standards, which can result in the introduction of counterfeit medicines that lead to serious harm and even death.
Unfortunately, there is a proposal pending in Congress that would allow for the importation of foreign drugs, exposing our country’s homes and pharmacies to potentially counterfeit, unapproved or adulterated medicines. That is why a broad range of stakeholders have come out against this dangerous and risky proposal.
“The proposed law requires foreign drug distributors to certify compliance with certain safety protocols. But foreign pharmacies, for example, do not need to verify the accuracy of their submitted reports. Even if FDA regulators suspect a foreign pharmacy is lying, the U.S. government legally cannot enforce compliance. In short, the government must blindly trust foreign drug distributors.
“That’s why four former FDA commissioners from the Obama and Bush administrations oppose the current bill. They recently wrote an open letter warning that “obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.
“If the bill passes, counterfeiters could exploit these weaknesses to “transship” drugs from unreliable developing markets, through supposedly safe countries, and then on to the United States.”
Not only would drug importation expose individuals to greater risk of counterfeit or adulterated drugs, it would also exacerbate the nation’s opioid crisis. George M. Karavetsos, the former director of the U.S. Food and Drug Administration’s Office of Criminal Investigations discussed the bill in The Philadelphia Inquirer.
“America’s fentanyl problem would be even worse if not for our strict drug-importation laws and our dedicated cadre of law enforcement officials. As director of the FDA’s Office of Criminal Investigations, I saw firsthand how our agents prevented dangerous counterfeit and illegal drugs from reaching consumers in the United States.
“Canadian law enforcement authorities also are struggling to cope with widespread fentanyl trafficking. Police in British Columbia recently discovered that a ‘custom car business’ was shipping 100,000 fentanyl pills a month to Calgary. Police believe the pills originated in China.
“If Congress were to pass the Affordable and Safe Prescription Drug Importation Act, it would become relatively easy for dealers to order fentanyl through the mail from Chinese and other foreign drug labs posing as online pharmacies. There are thousands of rogue Internet pharmacies operating abroad. It would be nearly impossible to determine which ones are shipping actual prescriptions and which ones are shipping illicit opioids.”
Drug importation is a prescription for disaster that the American people cannot afford. Fortunately, there are more responsible solutions for lowering drug costs, ones that would provide greater access to affordable medications and protect patients.
The Coalition for Affordable Health Care — representing drug makers, insurers, consumer advocates, pharmacy benefit managers, and others — has put forward a set of consensus reforms for reducing drug prices, such as speeding the approval of generic drugs and rewarding value instead of volume. You can learn more about these and other commonsense solutions here.