If drug importation was allowed, nearly 40% of off-patent drugs with limited US competition could have enough competitors to help ensure low prices
The rising cost of prescription drugs in the US continues to be the focus of intense scrutiny. As patients find both new and long standing treatments inaccessible because they cannot afford them, the burden of overall US spending on pharmaceutical products is also troubling. In a recent poll of US adults, 61% of respondents said that lowering the cost of prescription drugs should be a “top priority.” In 2016, the US spent $450bn (£323bn; €364bn) on prescription drugs, a number expected to increase to $610bn by 2021.
A large part of this spending is made up of patented drugs newly approved by the US Food and Drug Administration (FDA). One of these is the first drug seeming to cure hepatitis C, which at $84 000 per course of therapy brought attention to the shockingly high prices of many newly approved drugs. Public attention has also been paid to the rising prices of some older drugs, which, despite no longer being protected by patents, often lack the downward driving pressure of robust competition. In some cases, without competition, pharmaceutical entrepreneurs have been able to acquire the rights to drugs and dramatically raise their price, as was the case with Turing Pharmaceutical’s acquisition of pyrimethamine (Daraprim).
To tackle this problem, the FDA recently published lists of off-patent drugs that have few competitors, with the aim of attracting rivals to enter the market for individual drugs. In addition, as we recommended in 2016, the FDA now plans to expedite the review of additional generic drug applications in the hope of increasing the level of generic competition for drugs with three or fewer manufacturers. One approach that could expand the competitive market for these products would be to import versions of these drugs sold in other countries with comparable regulatory standards.
Over the past few years, policymakers from both ends of the political spectrum—such as senators Ted Cruz (Republican-Texas), Bernie Sanders (Independent-Vermont), and Amy Klobuchar (Democrat-Minnesota)—have filed legislation relating to drug importation. Frustrated by the growing strain on government budgets, individual states—including Maine, Vermont, and Utah—have also tried to pass legislation that would facilitate importation for local patients.
Our recent study published in The BMJ evaluates the potential impact of such a strategy on generic competition in the US. We found that if drug importation was allowed, nearly 40% of off-patent drugs with limited US competition could have enough competitors to help ensure low prices. Unexpected drugs shortages would also be less likely to occur.
Although there has been concern that importing drugs could endanger patients, a substantial proportion of drugs approved by the FDA and currently sold in the US are already manufactured abroad. Safe and reliable importation systems for this purpose can be designed.
As internists, prescription drugs are among the most critical tools in our arsenal, so their affordability constitutes one of the most significant social justice issues of our time. In both the hospital and clinic, we regularly care for patients who feel the pressure of balancing the cost of drugs with that of rent and food. Patients are repeatedly admitted to hospital struggling to breathe because they are unable to afford inhalers to treat their chronic obstructive pulmonary disease. There are other patients who find insulin—originally isolated almost 100 years ago—to be prohibitively expensive for treating their diabetes. Health departments are feeling the effects of expensive drugs: in a recent meeting, one of us heard how the city in which we work is struggling to pay for naloxone, a decades old, life saving antidote for opioid overdoses. Such stories are sadly common in the US.
Importing drugs is clearly not a silver bullet for the entire problem of expensive drugs, and many questions around how best to implement this strategy remain. If we are serious, however, about reining in prices, we can combine drug importation with other systemic solutions, such as allowing Medicare to negotiate drug prices with manufacturers and achieving more transparent pricing from pharmaceutical manufacturers and pharmacy benefit managers. Ultimately, as physicians, our prescriptions can only be effective if our patients can afford them.
Ravi Gupta is an internal medicine intern in the Osler Medical Training Program at Johns Hopkins Hospital in the Urban Health track.
Competing interests: None declared.
Aaron Kesselheim is an associate professor of medicine at Harvard Medical School. He is also the director of the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.
Competing interests: See research study.
1. Kirzinger A, Wu B, Brodie M. Kaiser health tracking poll: health care priorities for 2017. Kaiser Family Foundation 2017. www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-health-care-priorities-for-2017
2. Iqvia Institute for Human Data Science. Medicines Use and Spending in the US. 2017. www.iqvia.com/institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2016
3. US Food and Drug Administration. FDA in brief: FDA works to encourage and optimize drug competition with transparency. 2017. www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm589275.htm
4 Gupta R, Kesselheim AS, Ross JS. Prioritization of generic drug review: reply. JAMA Intern Med 2017;177(1):141-42. https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2594766?redirect=true
5 Bollyky TJ, Kesselheim AS. Can drug importation address high generic drug prices? Brookings. 2017. www.brookings.edu/research/can-drug-importation-address-high-generic-drug-prices