Think tank calls for FDA to forgo approval of drugs cleared by European regulator

The free-market Pacific Research Institute argues in a new report that American patients would benefit if the Food and Drug Administration didn’t have a monopoly on regulations.

Instead, the think tank argues that “allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable more 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 new medicines approved by the FDA and the European Medicines Agency (EMA) in 2008 and 2009, 11 were approved only by the EMA. In addition, the approval time was 97 days faster on average in the European Union for the 13 medicines approved by both regulators.

“Clearly,” the think tank argues, “Congress’s grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines.”

The report goes on to recommend: 

• Amending the Food, Drug, and Cosmetic Act to require the FDA to approve a New Drug Application when the drugmaker notifies the FDA that a comparable foreign jurisdiction, such as one in the EU, has lifted its ban on the new medicine.

• Enacting Rep. Diane Watson’s (D-Calif.) Compassionate Access Act, which would authorize the Secretary of Health and Human Services to permit an unapproved drug be made available under certain conditions if a patient is seriously ill, has exhausted other treatments, and is ineligible for a clinical trial for various reasons.