WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today released the following statement on the sequestration budget cuts that begin to take effect on March 1. ASBM Chairman Dr. Richard Dolinar said the following:
“The Affordable Care Act, enacted in March 2010, authorized the U.S. Food and Drug Administration (FDA) to develop a pathway for the approval of biosimilars. For the past year FDA employees have been working tirelessly to establish the pathway that will make these breakthrough medicines available to patients in the U.S.
“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.’
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.