28 Oct 2020
Posted in Medical Devices
Election outcome could impact medical device approvals if FDA becomes politically focused
The different stances of the Republican and Democrat parties in terms of the apolitical nature of the Food and Drug Administration (FDA) has come to light during the COVID-19 pandemic. Politicization of the FDA would likely have a negative effect on both medical device markets and regulatory approval processes, says GlobalData, a leading data and analytics company.
Ashley Young, Senior Medical Devices Analyst at GlobalData, comments: “Historically, the FDA has based its regulatory decisions solely upon sound scientific evidence and expertise. Any future change to this paradigm will have unpredictable impacts on medical device markets. Some manufacturers may benefit from politicization of the FDA. For example, devices used to treat COVID-19 are likely to be promoted by governments while the economic implications of the virus are at play. However, manufacturers of other devices may suffer, such as any device that does not align with the governing body’s political views. For instance, if a ruling government does not support abortion rights, a politicized FDA may be influenced to slow or block approval of such devices.”
Since the pandemic started, it is noted that the Republican party has been applying political pressure to the FDA – for example, Trump tweeted in August his belief that the agency was intentionally slowing down medical device approvals to hamper his re-election chances; and he appointed a conservative political activist as assistant commissioner for media affairs – a choice some have deemed to be based more on political values than scientific experience. Meanwhile, the Democrats have critiqued the claimed Republican involvement in the FDA, and three Democratic senators recently called on an independent watchdog agency to investigate whether or not the CDC and FDA’s scientific integrity had been compromised due to political interference.
Young adds: “The unpredictability of any politicization of the FDA would have a negative effect on medical device markets overall, since it would make the already tricky regulatory approval process for medical devices even more difficult for manufacturers to navigate.”