American patients should be allowed access to drugs approved by the European Medicines Agency (EMA), a new US report argues.
A report by the Pacific Research Institute has suggested that American patients would benefit if the FDA did not have a monopoly on regulations, as the EU agency approves more medicines and has faster approval times.
The US think tank argues that “allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable patient choice and potentially save the lives of those suffering life-threatening illnesses and who currently have no treatment options.”
The report shows that, of 39 medicines approved by the EMA and FDA in 2008 and 2009, 11 were only approved by the EMA. The EMA’s average approval time was 97 days faster than the FDA’s for medicines approved by both regulators.
“Clearly, Congress’ grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines,” the Institute argues.
The report recommends that the Food, Drug and Cosmetic Act is amended to require the FDA to approve a new drug if it has been accepted by a ‘comparable foreign jurisdiction’, such as the EMA.
Tags: EMA, FDA, regulatory authorities