Two major pharmacy groups have written to President Trump in an effort to prevent legislation that will allow non-FDA approved drugs to be imported into the United States. The National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) believe that the legislation would lead to an influx of unsafe drugs.
, supported by Senator Bernie Sanders (I-VT), aims to allow the importation of drugs from Canada, and possibly later drugs from Europe. The goal is drive down the cost of drugs by importing cheaper drugs. The senators and representatives sponsoring the bill are appealing to President Trump’s comments about pharmaceutical companies “getting away with murder
NACDS and APhA also oppose
the HHS’ ability to temporarily allow for private importation of drugs. “To support broad importation or exercise HHS’ waiver authority,” they said in the letter, “is to compromise the integrity and security of the supply chain for prescription drugs.”
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They provide four pieces of evidence showing that drug importation could be harmful:
The Drug Supply Chain Security Act (DSCSA) is undermined by drug importation.
Both the FDA and the Canadian government have previously had concerns.
Importation increases the risk of counterfeit drugs in the supply chain.
Importation detracts from value-based care.
The two groups support “efforts to improve patient access to affordable and safe medications,” such as DSCSA, which tracks prescription drugs from the manufacturer to the dispenser. With importation, they argue, “[t]he risk of foreign counterfeit drugs is too high, and the consequences for United States consumers are too deadly.”
The two groups are not the first to oppose importation. In March, four former FDA heads—Robert Califf and Margaret Hamburg from the Obama Administration and Andrew von Eschenbach and Mark McClellan from the George W. Bush administration— crafted a letter
to Congress urging them not to pass the bills through.
Drug importation, they wrote, would likely “harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation's medical products.” While some might believe Canada is a safe bet, the authors warn against it. Califf, as reported by the Washington Post
, said in an interview that “the vast majority of Internet sites that advertise as being Canadian are actually based in South America, Eastern Europe, and Russia.”
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“What if you think you are taking a statin, but you aren't?” he asked. “You wouldn't feel any different. ... And what if you were 70, with six medical problems being treated with 10 drugs, and you got sick and died. Who would know?”
The current FDA head, Scott Gottlieb, has also voiced similar concerns. In an article published last year in Forbes
, Gottlieb wrote
that, “drug importation doesn’t address any of these core challenges [of making drugs more affordable]. In fact, the imported drugs may end up being quite expensive.”
He added that, “I worked on sketching an importation scheme for the FDA regulation of imported drugs when it looked like similar legislation would pass in 2004. That scheme would have added so much cost to the imported drugs; they wouldn’t be much cheaper than drugs sold inside our closed American system.”