Is expressing a concern for counterfeit drugs an excuse to crack down on cheap drugs that Americans import from Canada?
A. No, the FDA is concerned about unsafe counterfeit drugs from any country. Counterfeits are not equivalent in quality, safety, and efficacy to the authentic drug. Counterfeits may enter the U.S. distribution system from within the U.S. or from other countries, including Canada. FDA is not attempting to single out any individual country in its efforts to protect Americans from counterfeit drugs. FDA can only ensure that FDA-approved products that have undergone the extensive review process are safe and effective; many products from other countries have not undergone this process and therefore present potential safety risks.