With US prescription drug prices among the highest in the world, legislation has been proposed that would allow cheaper foreign imports. However, opponents say this would undermine the undermine supply chain security and compromise drug quality. Abi Millar explores both sides of the debate.
Might drug importation from foreign markets be a way to improve patient access? It’s a question that many in the US are weighing up. Given the problems surrounding drug affordability, with pricing scandals barely out the news, it is easy to see how the idea has emerged of sourcing these drugs from elsewhere.
Since the start of the year, a number of proposals have been introduced, covering both personal and commercial importation. Most recently, the Senate convened to discuss the Prescription Drug User Fee Act, (PDUFA) which is due to expire in September. While they were fairly unequivocal about reauthorizing PDUFA, voting 21-2 in favour, Senator Bernie Sanders added a note of controversy into the mix.
He proposed an amendment allowing drug imports from Canada, while lamenting the stranglehold the pharma industry had over Congress. This proposal, which was tabled, is expected to be taken up at a later stage on the Senate floor.
Other proposals have taken a similar tack, with some limited to Canada and others broader in scope. For instance, at the House Energy and Commerce Committee hearing on the PDUFA, Congressman Peter Welch proposed his own amendment surrounding the import of ‘affordable and safe drugs from Canada’. Although this proposal failed on a voice vote, more amendments of this nature could be considered further down the line.
Unfortunately, many industry lobbyists see the proposals as deeply misguided. According to an op-ed on the political website The Hill: “The risks far outweigh the benefits. Importation would threaten and destabilize the significant industry-government collaboration already underway to ensure the safety and security of the domestic pharmaceutical supply chain.”
This op-ed was written by John M. Gray, president and CEO of the Healthcare Distribution Alliance (HDA) and Steven C Anderson, president and CEO of the National Association of Chain Drug Stores (NACDS). Both industry bodies, they said, were strongly opposed to any amendment that would enable drug importation.
At first blush, it may seem peculiar that drug importation is attracting so much opposition. The US has some of the highest prescription drug costs in the world, with few checks in place to stop costs from spiralling further. Witness Mylan’s EpiPen allergy medicine, which surged in cost by about 600% between 2007 and 2016, or the antibiotic Doxycycline, which jumped from $20 a bottle in October 2013 to $1,849 a bottle six months later. Any strategy that might redress the issue surely has laudable aims.
It is no wonder that 72% of Americans support the idea of importing medicines from Canada, according to a recent Kaiser Family Foundation poll.
The problem with imports, say critics, is that they would undermine supply chain traceability, undoing all the good work that has been accomplished in recent years and allowing for an influx of unsafe drugs.
Stronger supply chain
As John M Gray of the HDA explains, the Drug Supply Chain Security Act (DSCSA) was a pivotal moment for the US pharmaceutical supply chain when it was enacted in 2013.
“Simply put, we cannot go back to a pre-DSCSA environment,” he says. “Nearly four years after enactment, the supply chain is already stronger and more efficient given the requirements that already have been met. Any proposal, such as importation, undermines Congress’ and the industry’s hard work, jeopardises the significant progress already made, and puts the patients we serve at risk.”
This view makes sense when you consider what the DSCSA was designed to achieve. While the bill itself is complex, the problem it aims to solve is clear – namely the issue of counterfeit drugs infiltrating the US supply chain. By the time the law is fully implemented in 2023, every prescription medicine will be electronically traceable to its source.
“This will provide stakeholders greater visibility into how pharmaceuticals move throughout the system,” says Gray. “This stronger, more efficient supply chain is especially important for healthcare providers, pharmacies, and the patients they serve, because it reinforces the system against counterfeit and substandard medicines.”
The problems surrounding drug counterfeiting are very real. While it has never been hugely prevalent in the US, there have nonetheless been several unfortunate incidents. In 2005, 18 million Lipitor tablets were recalled due to criminal activity, and fake versions of the weight loss drug Alli were sold online in 2010. In one particularly tragic case, an Arizona woman died after taking a counterfeit cancer drug that turned out to be water and mould.
The DCSCA will hopefully prevent such occurrences happening in future. However, if the supply chain were opened up to foreign imports, it would potentially expose US patients to poorly regulated markets, illegitimate medicines (potentially worsening the opioid crisis), and online scams.
“Many websites that display a maple leaf or union jack are actually located in or sourcing drugs from countries like Nigeria or China where facilities aren’t inspected or regulated by the FDA,” wrote former Democratic congressman Ron Klink in a blog for The Hill. He added that, in one study, almost 96% of internet pharmacies were found to be scams.
Weighing up the risk
For advocates of foreign imports, such pronouncements are little more than scaremongering, grounded more in maximising pharmaceutical profits than ensuring patient safety. They argue that the Canadian market is held to extremely strict regulatory standards, and that purchasing drugs through licensed online pharmacies is very safe.
Other lobbyists have argued that, while it may be hard to justify Canadian importation across the board, it should be allowed in special circumstances. Senator John McCain has suggested these might include cases where the drug is no longer marketed in the US, or where there have been ‘significant and unexplained increases in price’.
The difficulty, of course, is that importation of any kind would throw the DSCSA into disarray, causing a headache for the many supply chain stakeholders who are now four years into implementation.
“Recent importation proposals do not allow for certain mandatory transactional requirements established by the DSCSA, which were created to strengthen the supply chain,” says Gray. “Further, it will be difficult to ensure that imported products designated for foreign markets meet the standards of safety and security that are necessary to ensure the integrity of the supply chain.”
He adds that traceability systems do not match up from one country to the next. While some compatibility does exist (i.e., through the use of global standards for product identification and so forth), many of the particulars are incompatible.
“Just as supply chains are unique, the traceability framework sought by DSCSA is designed differently from the systems in other markets, such as the EU,” he says.
The debate continues
What will happen next remains to be seen, with passionate arguments being raised on either side. For supporters of importation, some risk is permissible if it improves patients’ access to life-saving drugs. For detractors, securing the supply chain is paramount, and the accessibility issue should be tackled through other means.
“With Congress grappling with issues surrounding the value and affordability of prescription drugs, supporters of importation have presented it as an easy policy solution to the problem,” says Gray. “As noted already, importation is not such a simple solution – it actually would undermine pharmaceutical stakeholders’ efforts to keep the supply chain efficient and secure.”
He adds that the HDA, along with its supply chain partners, will continue to advocate against importation.
“While we do not know where the debate will end up, the political pressure has been significantly charged during this Congress and we will continue to actively express our opposition,” he says.
This article appears in the August 2017 edition of Pharma Technology Focus