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How HHS efforts to increase competition could hurt patients.
Everyone on the “buy side” wants lower cost medicines. But at what cost? As Congress and other Administration officials attempt to make medications more affordable, patient safety must not be sacrificed.
In January, two federal importation bills were introduced, along with a slew of state-based bills, signaling policymaker’s prioritization of this policy. The federal bills would allow for the personal importation of prescription drugs from Canada as well as wholesale drug importation, in certain instances. Already this year the U.S. House and Senate have held several drug pricing hearings during the first few weeks of the 116th Congress that have included importation. State legislatures are also considering importation proposals, mostly on the wholesale side. Importation bills were introduced in 10 states in 2018; more are expected in 2019.
Efforts to allow for importation belie real issues in drug pricing, and instead, offer a politically popular but unworkable option. Foreign sellers can already increase competition by working with authorities to export FDA-approved products to the U.S. via the legitimate supply chain. Further, the proposed importation policies do not directly address the core issue of domestic prices and overlook the significant risks to patient safety associated with sourcing drugs from outside the closed U.S. supply chain.
Relaxed Important Requirements
Pharmacists are willing to consider novel approaches to lower the cost of medications but are concerned the recent legislative proposals will result in patients sourcing and relying upon non-FDA approved medicines, including potential counterfeit products outside of the secure supply chain we work so hard to maintain. Consequently, patients purchasing these medications will unknowingly bear the greatest risks.
Current laws protect patients. When FDA-approved medications are purchased, patients do not question their quality. Make no mistake, the burden of ensuring safety and effectiveness of medicines would become “caveat emptor” or let the buyer beware and thus unwittingly place patients in peril from counterfeits or, diverted products should current importation legislation advance.
Demand for convenient, lower-cost medications has created a new economic incentive for criminals to manufacture and sell dangerous-sometimes deadly-counterfeit drugs. Counterfeits are often manufactured in unsafe conditions; contain too much, too little, or no active ingredients; and/or may be made using dangerous or deadly substances, including fentanyl, floor wax, and other harmful substances. Congress aimed to secure the U.S. supply chain from these risks in passing the Drug Quality and Security Act; a robust 2013 law which the U.S. pharmaceutical supply chain is currently implementing. We should be cautious to not undermine the safety processes this law put in place.
As rational economic actors, drug counterfeiters regularly trade in the highest-cost, hardest-to-get, and most sought-after products based on American demand. Whenever there is a drug shortage, public health crisis, or price spike, counterfeiters and criminals swoop in, and target patients by offering access, “deals,” and even “cures.” The following are just a few of the headlines highlighting FDA’s recent efforts to address this problem: FDA crackdown on fake “Ebola cures” sold online; FDA warns of fraudulent/unapproved flu products; FDA warns against fake cancer treatments.
Should lawmakers and other health authorities authorize importation of prescription drugs, we should expect criminals to similarly flock to that new market, placing patient safety and public health at substantial risk.
Officials struggle to stop dangerous fakes from entering the country. Counterfeit pills laced with fentanyl and other synthetic opioids are shipped into the U.S. in mass quantities from foreign sources, killing Americans. In July, the U.S. Attorney for the Southern District of New York announced the arrest of two individuals for advertising and selling controlled substances through an illegal online pharmacy. In August 2018, two Chinese nationals were charged in a global opioid and drug manufacturing conspiracy that involved the manufacture and distribution of synthetic opioids that spanned more than 25 countries, hundreds of drug analogues and resulted in at least two confirmed deaths. Expanding mechanisms available to import foreign-sourced medicines to the U.S. would exacerbate an already overwhelming and unmanageable safety situation. FDA Commissioner Gottlieb has noted it is estimated that FDA is able to physically inspect less than 0.06% of all packages entering international mail facilities thought to contain drug products.
Legislators’ actions could also have the unintended consequence of suggesting to Americans that it’s safe to buy any medicine from foreign sources. Messaging matters. We must guard against the risk that Americans might misinterpret the efforts of Congressional leaders and Administration officials to suggest it’s safe to purchase medicine from foreign sources anytime.
U.S. consumers buying medications from Canadian online pharmacies rarely, if ever, receive the same regulator-approved products provided to Canadian consumers. Indeed, the FDA has found that 85% of drugs promoted as “Canadian” came from 27 other countries, including India, Costa Rica, and Vanuatu. Just as online criminals currently pass themselves off as “Canadian,” allowing even a limited legal means of importation would cause criminals to likewise pass themselves off as meeting the requirements of a new restricted importation policy.
While the government and healthcare community look for comprehensive policy solutions for drug pricing, resources from websites like www.BuySafeRx.pharmacy and www.safe.pharmacy are available now to help consumers stay safe and verify the legitimacy of websites before they buy medicine online. Pharmacists in all practice settings can play an important role in educating patients about their buying options, including ways to identify and coordinate cost-effective treatments that consider individualized needs as well as payer policies. Pharmacists can help optimize the impact of patients’ medications but cannot do this effectively when patients’ medications are not safe or effective.
While we share the goal of increasing patient access to safe, affordable medicine, the potential cost-saving benefits of importation policies must be sufficiently weighed to account for the considerable risks to patients. We urge Congress and the Administration to carefully consider pharmacists and pharmacists’ perspective in policy decisions that impact patient access to safe and effective medications.
Thomas Menighan, BSPharm, MBA, is CEO of American Pharmacists Association.
Libby Baney is a partner with Faegre Baker Daniels and a senior advisor to the Alliance for Safe Online Pharmacies (ASOP Global) and the ASOP Global Foundation.