Over 100 advocacy organizations urge WH and Congress not to endanger Americans with importation of non-FDA approved drugs

Dear President Donald J. Trump, members of the United States Senate, and members of the United States House of Representatives:

As organizations that represent thousands of law enforcement, healthcare professionals, patient advocates, taxpayer organizations, business groups, and consumer interest groups, we are writing to express our deep concerns with and opposition to proposals to import non-FDA-approved medications that would endanger the health and safety of our communities.

Importing non-FDA-approved medications outside the licensed and secure supply chain endangers patients

Historically, attempts to import drugs from “safe countries” like Canada result in Americans getting counterfeit, substandard or black market medication. These substandard products are often trans-shipped through Canadian free trade zones or shipped directly from countries like China or India, but they never enter the Canadian regulatory sphere.

There is no oversight, safety enforcement or United States FDA protection for medication obtained from foreign entities unlicensed in the United States. Health Canada does not inspect, regulate, or supervise the medication from other countries that Canadian companies sell to Americans because they aren't bringing those medicines into the Canadian drug supply.

Four previous United States Food and Drug Administration commissioners have studied this problem and concluded that the added costs of attempting to secure medicine from black market sources would eliminate any savings possible through such a program. They are clear that American patient safety would be compromised.

Every day, United States law enforcement is working to prosecute these foreign counterfeiters, but they sometimes have a great deal of difficulty bringing them back to the United States for trial even when these counterfeiters have cost American lives. As has been noted in law enforcement efforts to stem the crisis of Chinese-made fentanyl, China and the United States do not have an extradition treaty. This requires that we get permission from the Chinese government to prosecute cases when their citizens harm Americans: permission we won’t always receive.

For many patients, a counterfeit medicine with substandard or no active ingredient is a death sentence, even if it does not contain dangerous additives. For individuals with HIV, these counterfeit medicines can impact viral suppression and create life-long treatment resistance. For those battling cancer, a counterfeit medication means that tumors grow unchecked and the patient’s fight against cancer is thwarted by a crime they may never detect.

Importing medications will worsen the opioid crisis and endanger law enforcement

According to the Centers for Disease Control, over 29,000 Americans overdosed on synthetic opioids such as fentanyl in 2017, most of which is imported from Chinese labs by global drug smugglers, including global drug cartels such as the Sinaloa cartel. As of the writing of this letter, fentanyl-based counterfeit medications have been found in 45 states and killed Americans in at least 26 states that the Partnership for Safe Medicines has documented.

Increasing the importation of black market medical products will make it harder to catch these dangerous products at the border, causing more American deaths. Additionally, since the explosion of synthetic opioid abuse in 2015, first responders have reported dangerous fentanyl exposure incidents in 17 states.

Importing medications will directly disrupt the gold standard United States supply chain and create new liabilities for healthcare providers

As rare as counterfeits are in the closed, regulated drug supply chain, they have devastating results for patients involved. The Drug Quality and Security Act of 2013 set in motion a multi-year, extremely complex implementation of supply chain safety measures. Importation from unregulated foreign entities will break this “track and trace” system. Again, FDA Commissioners from both Republican and Democratic administrations have vocally opposed allowing importation. As fellow Americans, we do not discount the issue of financial barriers to access all forms of healthcare including medicine. However, there are a broad array of policy proposals that address concerns about medication. Legalized importation of non-FDA-approved medication should not be one of them.

We remain committed to working with you to better understand the concerns of our community. Our organizations may be contacted via the Partnership for Safe Medicines at 2019letter@safemedicines.org or through PSM’s Executive Director Shabbir Imber Safdar at the same email.

Sincerely,

Academy of Managed Care Pharmacy

Action CF

ADAP Advocacy Association

Advocates for Responsible Care (ARxC)

The AIDS Institute

Alabama Pharmacy Association

Alaska Pharmacists Association

Alliance for Safe Online Pharmacies

Alzheimer's & Dementia Resource Center

American Autoimmune Related Diseases Association

American Pharmacists Association

Arizona Pharmacy Association

The BASE Chicago

BeMedWise

BioForward Wisconsin

BioNJ

Brain Injury Association of DE

Buckeye State Sheriffs' Association

California Pharmacists Association

Caregiver Action Network

Caregiver Voices United

Center for Medicine in the Public Interest

Centro de Mi Salud, LLC

Children's Cause for Cancer Advocacy

Colorado BioScience Association

Colorado Gerontological Society

Colorado State Grange

Colorectal Cancer Alliance

Commerce and Industry Association of New Jersey

Community Access National Network (CANN)

Consumer Action for a Strong Economy

Council for Affordable Health Coverage

Council for Citizens Against Government Waste

Delaware BioScience Association

Delaware Ecumenical Council on Children and Families

Delaware HIV Consortium

Delaware Pharmacists Association

Dia de la Mujer Latina

Easterseals Central Texas

Florida Pharmacy Association

Georgia Pharmacy Association

Hawaii Pharmacists Association

Healthcare Distribution Alliance

HealthCare Institute of New Jersey (HINJ)

Healthcare Leadership Council

Hope Over Addiction

Illinois Pharmacists Association

Indiana Pharmacists Alliance

Indiana Sheriffs' Association

Institute for Safe Medication Practices

International AntiCounterfeiting Coalition

Iowa Pharmacy Association

Kansas Pharmacists Association

The Latino Coalition

Maine Pharmacy Association

Maryland Pharmacists Association

Massachusetts Independent Pharmacists Association

Men's Health Network

Michigan Pharmacists Association

Minnesota Pharmacists Association

Mississippi Pharmacists Association

Missouri Pharmacy Association

National Alliance of State Pharmacy Associations

National Alliance on Mental Illness - Washington State

National Association of Boards of Pharmacy

National Association of Drug Diversion Investigators (NADDI)

National Association of Hispanic Nurses Houston

National Association of Manufacturers

National Association of Nutrition and Aging Services Programs (NANASP)

National Black Justice Coalition

National Black Nurses Association

National Consumers League

National Cyber-Forensics and Training Alliance

National Grange of the Order of Patrons of Husbandry

National Hispanic Council on Aging

National Minority Quality Forum

The National Puerto Rican Chamber of Commerce

Nebraska Pharmacists Association

NeedyMeds, Inc.

The Nevada Sheriffs’ and Chiefs’ Association

New Hampshire Pharmacists Association

New Jersey Association of Mental Health and Addiction Agencies, Inc.

New Jersey Pharmacists Association

New Mexico Pharmacists Association

North Dakota Pharmacists Association

Northwest Parkinson's Foundation

Ohio Pharmacists Association

Oklahoma Pharmacists Association

Oncology Managers of Florida

Oregon State Pharmacy Association

The Partnership for Safe Medicines

Pennsylvania Pharmacists Association

Pharmaceutical Industry Labor-Management Association

Pharmaceutical Security Institute, Inc.

Pharmacists Society of the State of New York

Quality Connection

Re: Cancer

RetireSafe

Rx Partnership

Salud USA

South Carolina Pharmacy Association

South Dakota Pharmacists Association

Taxpayers Protection Alliance

Tennessee Pharmacists Association

Texas Association of Manufacturers

Texas Pharmacy Association

Valley AIDS Council

Vermont Pharmacists Association

Virginia Bio

Virginia Pharmacists Association

Washington State Pharmacy Association

Young People in Recovery