Former commissioners of the Food and Drug Administration have leveled strict warnings over the danger of importing drugs from countries outside the United States. Legislation proposes that many regulations currently in place need removed, making it legal to import certain drugs. Although the idea has limited political support, the last four FDA commissioners have collectively felt it is a terrible idea.
Legislators, including Bernie Sanders and President Donald Trump, believe importation of drugs would help create competition and reduce the costs for American citizens. Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan all feel this a dangerous policy that puts people at risk.
They all believe that imported drugs from outside the US borders will suffer from potentially lower quality standards, so the tradeoff for cheaper prices will not necessarily mean better drugs. Additionally, there is the glaring problem of contamination and even fake drugs. They assert that ineffective products will infiltrate the US drug market, putting patients who rely on the credibility of the drugs at risk.
Robert Califf insisted that many of the drug providers claiming to be from Canada, actually operate out of different countries around the world. Without any way to enforce regulations, he believes that the drug trade, if allowed to be an open free import market in the US, will become a playground for organized crime.
During the campaign, President Trump took issue with many of the former commissioner’s concerns, but there has been no policy change yet. Furthermore, Trump’s nominee to be the new head of the FDA, Dr. Scott Gottlieb, now agrees with his four most recent predecessors. Gottlieb insists that the proposed policy may not actually produce lower costs, but would definitely increase the significant risk to consumers.
The FDA laws still prohibit the importation of drugs to the United States. While they are aware that some citizens bring back small prescriptions from Canadian pharmacies for personal use, they believe this is very different from allowing unregulated importation. It’s the Internet pharmacies across the world that the FDA believes would be prone to unregulated corruption and fraud.
It seems likely that the current administration may strongly consider the advice of those associated with the FDA office for the last 2 decades and stick with current policy. Current FDA practices, oversee the manufacture quality and the security of making sure US citizens receive safe and reliable drugs.