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Giving Compass' Take:
• George Ball reports that the market pressure demanding cheaper devices and drugs encourage companies to cut corners - leading to increased recalls of medical devices and drugs.
• How can funders work to increase the quality of devices and drugs at scale to prevent recalls?
• Learn about the risks of price controls for prescription drugs.
From the valsartan blood pressure drug contamination that exposed thousands of patients to cancer-causing impurities, to a massive pacemaker recall undertaken to fix a hazardous software bug in half-a-million cardiac devices, health care product quality problems are ever-present and highly dangerous.
In fact, medical product recalls – in particular severe, life-threatening pharmaceutical drug and medical device recalls – have increased steadily over the last decade.
It is no surprise that medical product recalls are universally negative events. Firms seek to avoid them, customers despise them, and federal regulators are forced to oversee them. They are associated with millions of dollars of unwanted corporate costs and stock price declines, along with substantial and costly regulatory oversight each year.
I spent over a decade as a manufacturing manager in Fortune 500 medical device firms, making scores of recall decisions and recommendations – some good decisions, some less so – and the last several years as an academic researcher committed solely to recall research. My colleagues and I have closely studied what causes defects that lead to recalls, as well as biases that exist in managers’ decisions to recall.
In capitalistic markets, competition is viewed as a force for good. Competition can lower costs, increase access, and hopefully improve quality. These benefits attributed to competition explain the steady call for greater access to generic drugs.
While it is seldom discussed in the crowded debate on health care costs, there may be a downside to the never-ending call for cheaper generic drugs and more affordable care.
Research conducted with my colleagues Rachna Shah from the University of Minnesota and Kaitlin Wowak from the University of Notre Dame shows that intense generic drug competition leads to an increase in severely hazardous manufacturing-related drug recalls.
Read the full article about recalls of medical devices and drugs by George Ball at The Conversation.