APhA, NACDS letter urges Trump to reject proposals allowing importation of non-FDA approved drugs

Safety of nation’s drug supply and patient health could be at risk, letter says

Citing patient safety and threats to the security of the nation’s drug supply, APhA and the National Association of Chain Drug Stores (NACDS) on June 1 sent a letter to President Donald Trump asking him not to support legislative proposals that would allow broad personal and commercial importation of non-FDA approved prescription drugs. The letter also asks that the Secretary of U.S. Department of Health and Human Services (HHS) decline to waive the general prohibition against personal importation of prescription drugs.

The letter notes that the Drug Supply Chain Security Act (DSCSA) of 2013 put in place requirements to “track and trace” prescription drug distribution throughout the drug supply chain—from manufacturers to dispensers—to prevent counterfeit drugs from reaching patients. “Any expansion of importation, personal and commercial, or exercise of HHS’ waiver authority, will undermine the DSCSA’s goal to protect consumers from exposure to dangerous counterfeit drugs,” APhA and NACDS write.

The organizations also note that FDA and Canada have historically agreed about the risk posed by drug importation of non-FDA approved drugs, both for individuals and the public. As such, the letter states, FDA should continue to have oversight of the drug supply chain.

Additionally, should importation restrictions be lifted, illegitimate online pharmacies selling counterfeit drugs—which have become more sophisticated and deceptive in their practices—could proliferate under the legislative proposals. Broader importation “removes safety mechanisms that protect patients from harm. Open importation and HHS importation waivers would greatly increase the probability of patients getting sick and dying from counterfeit foreign drugs,” APhA and NACDS write.

APhA and NACDS also express concerns about how open importation and HHS importation waivers could affect value-based care models. The organizations write that outcomes or value “will be more difficult to measure and optimize if patients are allowed to receive care outside the model’s mechanisms to drive results” and “U.S. health care providers and facilities may be unjustly penalized due to the actions of foreign providers or patients’ reactions to non-FDA approved medications.”

While APhA and NACDS affirm their support for efforts to improve patient access to affordable and safe medications, the organizations caution that open importation and HHS importation waivers could be counterproductive. “The risk of foreign counterfeit drugs is too high, and the consequences for United States consumers are too deadly. We look forward to continuing to work with FDA to implement the DSCSA and help consumers access drugs products through the existing supply chain,” the letter states.