Pharmacy groups warn of medicine import risks

Two major US pharmacy groups have waded into the debate over legislation that would allow cheaper drug imports into America, claiming the new rules would “compromise the integrity and security of the supply chain”.

In a letter to US president Donald Trump, the National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) “urge” the president to “refrain from endorsing” the importation proposals.

The two groups, which represent pharmacies and pharmacists, also oppose the HHS’ ability to temporarily allow for private importation of drugs.

The legislation, supported by previous democratic presidential hopeful Bernie Sanders, aims to address the ballooning cost of prescription drugs in the US by allowing the importation of cheaper drugs from Canada, and also possibly from Europe.

However, the proposals have met with strong opposition from the pharmaceutical industry and former US Food and Drug Administration Commissioners.

Now, NACDS and APhA are adding their voices to the fray.

“We support efforts to provide Americans access to safe, effective, and affordable prescription drugs, but allowing for broad importation or exercising HHS waiver authority on importation undermines the integrity and security of the US drug supply by posing an unreasonable risk to patient health and endangering public safety. We strongly oppose any expansion of importation of non-FDA approved drugs,” the associations write.

The two groups claim drug importation will undermine the Drug Supply Chain Security Act, which was passed in 2013 with the requirement to track and trace prescription drugs from manufacturer to receipt by the dispenser to prevent counterfeits entering the supply chain. NACDS and APhA say this protection from exposure to fake drugs will no longer occur if importation goes ahead because “proposals for importation fail to align with track and trace requirements of the DSCSA, as well as other DSCSA requirements involving licensure of supply chain participants, verification and validation of drug products, and the handling of suspect and illegitimate products”.

They claim that attempts to create alignment are “misguided” because enforcement of the Act over foreign facilities, manufacturers, wholesalers and dispensers “is practically impossible to achieve”, and suggest the legislation will create loopholes within the regulatory framework, increasing the risk of “easily allowing counterfeit drugs to slip into the United States supply chain”.

They back this up by noting the proliferation of unregulated foreign internet pharmacies, which purport to be located in countries such as Canada but are in fact located in other foreign countries with lax regulations and high volumes of drug counterfeiters. “The growing population of illegitimate foreign internet pharmacies directly leads to more and more counterfeit drugs being mailed into the United States, particularly in a United States regulatory environment that more openly allows drug importation,” they write.

NACDS and APhA also stress the “dire consequences” of counterfeit drugs, especially if they were to enter the broader supply chain. “People get sick and die from counterfeit medications… 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,” the associations write.

Furthermore, NACDS and APhA say, authorities including the FDA and the Canadian government have historically voiced their concerns over the risk to patient safety posed by importation of non-FDA approved drugs.

They cite current opposition to the legislation where four former FDA commissioners recently wrote to Congress saying: “We believe that such importation represents a complex and risky approach – one that the evidence shows will not achieve the aim, and that is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.”

They also point to comments made by Diane Gorman, assistant deputy minister of Health Canada, who said: “Health Canada does not assure that products being sold to US citizens are safe, effective, and of high quality, and does not intend to do so in the future.”

The two groups also claim that “broader importation laws will hinder the progress made to move US health care delivery and payment towards value, as opposed to volume, and further fragment care”.

“We support continued strong FDA oversight over the drug supply chain,” the groups write. “Only through such oversight can the public be assured that the drugs they receive are high quality, safe, and effective. To support broad importation or exercise HHS’ waiver authority is to compromise the integrity and security of the supply chain for prescription drugs… The risk of foreign counterfeit drugs is too high, and the consequences for United States consumers are too deadly,” the associations conclude.

NACDS and APhA’s letter follows US pharma lobby group PhRMA’s concerns over the legislation. In a statement in March, the trade body said importation would risk “potentially counterfeit and substandard drugs into the United States [that] are unsafe and put American patients at risk”, adding: “This is because the US government cannot guarantee that medicines entering the country via importation schemes will meet our strict safety standards.”