- The Director of the European Medicines Agency (EMA), Guido Rasi, is arguing that one way to address the drug pricing controversy is to provide expedited approval processes in return for companies settling on lower prices.
- The EMA’s 'adaptive pathways' initiative would be the primary vehicle for this proposal. Under this initiative, drugs would be approved early for restricted patient populations following small clinical trials. As further clinical data is collected, the approval could be expanded incrementally. Likewise, if new data showed drawbacks to a drug, the approval could be revoked.
- Rasi suggested this leaner, more efficient system could take years off of the standard approval times while making the development process less costly.
Concerns about skyrocketing drug prices, especially specialty meds, have dominated a lot of the conversations among regulators in both the U.S. and the E.U. Although prices are somewhat lower in the E.U., there are still many restrictions on reimbursement of certain drugs due to pricing levels.
In theory, Rasi's proposal could also possibly translate into a comparable process for FDA approval, with a similar impact on pricing.
But this method could also prove controversial and raise questions surrounding safety concerns. However, a drug could still be pulled from market if a problem occurred downstream after the original expedited approval.
Given that IMS Health has predicted 225 new drug approvals between 2016 and 2020, the pricing issue will likely become even more contentious.