// May 03, 2016

Congress to Remove Key Safety Component of Imported Medicines

Imported Biologic Medicines

Did you know that most drugs sold in the United States are imported from countries like India and China? That might surprise most people. 

The key protection for U.S. consumers—that should be maintained for all drugs sold in the U.S.—is that manufacturers of those drugs must adhere to a full range of FDA requirements – including requirements for product quality set by the United States Pharmacopeia (USP)—a nonprofit public health organization that helps protect American consumers and patients through public standards for the quality of medicines.

A pending proposal in Congress would remove key protections for all biologic drugs—crucial and lifesaving medicines we take like insulin, human growth hormone, and heparin—a blood thinner. We believe this move would pose a significant risk to the health of the American public. The Congressional proposal is simply “bad medicine.”

The Current Regulatory Situation

Existing consumer and drug-quality protections under the Federal Food, Drug, and Cosmetic Act require that any imported drug meet the same requirements that apply to domestic drugs.

Under proposals being considered by the Senate as part of the Innovation or “Cures” Act, that safety net would be removed for biologics for both foreign and US-manufactured drugs with regard to USP requirements for quality, labeling, and packaging.

While there are some other regulatory requirements that would still apply to these medicines, an important question is why strip away protections that have worked so well to help ensure that American medicines are of good quality and not adulterated?

The American drug supply is among the safest in the world, with many protections for consumers and patients. We should ask ourselves - do we really want to tamper with a system that has served the public well for over 100 years?

How do we ensure the safety of medicines that are coming from overseas and make sure they are manufactured safely and correctly? Keep current protections in place.

If you have questions about this proposed legislation, contact action@usp.org

Ben Firschein, J.D., LL.M., is the director of U.S. government affairs at USP.