A recent position paper from the American College of Physicians (ACP) states that the United States’ dysfunctional regulatory and market system underpins the high drug prices and slow progress biosimilars have made in the US marketplace thus far (Ann Intern Med. Published online September 15, 2020. doi:10.7326/M19-3773).
Many policies have been created to promote competition with the aim of decreasing costs for patients, said authors Hilary Daniel, and colleagues on behalf of the Health and Public Policy Committee of the ACP. Yet, many of these policies are now outdated and should be redesigned to better succeed in the current prescription drug market.
Their recommendations for change include:
- legislative reforms to the Orphan Drug Act that realign incentives;
- reduction of the period of data and market exclusivity for biologic drugs from 12 to 7 years and removal of additional barriers to biosimilar market entry;
- empowerment of federal agencies to address anticompetitive behaviors and gaming through guidance, congressional action, or additional resource support; and
- elimination of tax deductions for direct-to-consumer product claim advertisements.
“Increasing competition in the marketplace, and particularly introducing multiple competitor products for lower-cost generic or biosimilar drugs, is a cornerstone to controlling the increasing price of pharmaceuticals and achieving sustainability in the U.S. prescription drug marketplace,” wrote authors.
Wider availability of lower-cost drugs is vital if we want to reduce patients’ out-of-pocket costs, they said. “We must realign incentives that reward true innovation, prevent manufacturers from exploiting loopholes, and address business practices that lead to increased costs to the health system.”—Amanda Del Signore