The Real Cost of State Drug Importation Programs? Patient Safety

Michael D. Hogue
PharmD, FAPhA, FNAP
Executive vice president and CEO
American Pharmacists Association

With many Americans rightly frustrated about the skyrocketing prices of drugs, they are looking for creative solutions to provide some form of relief. The Food and Drug Administration (FDA) recently authorized Florida’s Agency for Health Care Administration to import certain prescription drugs under specific conditions from Canada. Although this proposal has raised hope for many Floridians of lower drug prices, this arrangement poses several risks, particularly to patient health, and is unlikely to deliver significant cost savings.

We know how important it is to balance access, affordability, and safety for patients. As professionals at the Academy of Managed Care Pharmacy (AMCP), American Pharmacists Association (APhA), and the American Society of Health-System Pharmacists (ASHP), we collectively represent pharmacists and pharmacy technicians across the country. We have long advocated for laws that help patients get access to affordable treatments. But we know firsthand how solutions must be designed in such a way that patient safety is not compromised. We have serious concerns that state importation programs open the door for unsafe drugs to enter the country, potentially endangering millions of Americans.

The U.S. has strict laws and procedures in place to ensure that all FDA-approved drugs are safe for patient use. Every single approved drug in the United States undergoes a rigorous FDA-led evaluation to guarantee its safety and efficacy before it is available for public consumption. Under the Drug Supply Chain and Security Act¹ (DSCSA), supply chain trading partners work closely to ensure that drugs in the U.S. are traced throughout the supply chain. This exhaustive process and closed drug distribution system protects patients from the risks posed by counterfeit and substandard drugs.

Susan A. Cantrell
MHL, RPh, CAE
CEO
Academy of Managed Care Pharmacy

Drug importation programs such as Florida’s may lack the requisite safeguards that protect Americans. As a result, we are worried that substandard drugs might enter the supply chain through vulnerabilities exposed during the importation process. Given supply chains are only as strong as the weakest link, drug importation programs would undercut the larger integrity of our nation’s approval process and drug supply.

Additionally, while states propose to import these medications from Canada, the Canadian market does not have access to enough medication to meet U.S. demand for discounted medications, and the Canadian government is working to prevent exports that would disrupt its own drug supply. The result is that state drug importation plans are unlikely to result in meaningful price reductions for American consumers.

Paul W. Abramowitz
PharmD, ScD (Hon), FASHP
CEO
American Society of Health-System Pharmacists

We understand that the ultimate goal of drug importation programs is to lower drug costs for patients. Given the costs associated with the handling and labeling of drugs during the importation process, true cost savings are unlikely. Drug affordability for patients is a priority for us at AMCP, APhA, and ASHP. That’s why we have supported many policy solutions, including some provisions in the Inflation Reduction Act.²

The bottom line

Florida isn’t the only place where we have concerns. Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin all have laws in place that allow for drug importation programs should they be authorized by FDA; in fact, the FDA is currently reviewing Colorado’s application for approval.

We understand the need to facilitate affordable access to life-enhancing and saving treatments and prescription medications. We recognize that innovation—both in laboratories and legislatures—is key to improving the quality of life for millions of Americans. But in this instance, the answer is not a quick fix that looks beyond our borders. We fear that state importation efforts pose too many risks to patient safety and will fail to deliver cost savings for patients. And in a field where “do no harm” is a credo that underpins our health care system, state drug importation programs raise too many legitimate questions.

Susan A. Cantrell, MHL, RPh, CAE, is the CEO of Academy of Managed Care Pharmacy. Paul W. Abramowitz, PharmD, ScD (Hon), FASHP, is the CEO of the American Society of Health-System Pharmacists, and Michael D. Hogue, PharmD, FAPhA, FNAP, is executive vice president and CEO of the American Pharmacists Association.

Sources

1. Pharmacists: Utilize DSCSA Requirements to Protect Your Patients. FDA. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients
2. IRA Resource Center. AMCP. https://www.amcp.org/policy-advocacy/legislative-regulatory-issues/ira-resource-center