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CVS Caremark gives FDA input on biogeneric approvals
November 2nd, 2010
WOONSOCKET, R.I. – In testimony for the Food and Drug Administration, a CVS Caremark Corp. executive reiterated the company's support that the agency implement regulations needed to approve biogeneric drugs under the Patient Protection and Affordable Care Act.
The company said that Scott Reid, senior vice president of specialty pharmacy operations, on Tuesday testified at an FDA public hearing to address the development of an approval pathway for biosimilar and interchangeable biological products.
"Every day, CVS Caremark supports patients who depend on specialty and other biotech drugs to provide critical treatment for their serious, chronic conditions, and we have long advocated for the creation of an FDA pathway for approval of biogeneric options," Reid stated at the hearing, held at the FDA's headquarters in Silver Spring, Md. "The availability of biogenerics will not only help health plans, employers and federal programs manage their drug spend but, more importantly, it will help make these extremely expensive medicines more affordable for patients."
CVS Caremark noted Reid's comments also touched on ensuring that pharmacovigilance programs for biosimilar and interchangeable products are consistent with programs for the innovator products and that added burdens not be imposed on pharmacies at the front lines of managing these programs, a situation that could impact patient access.
At the hearing, he also urged the FDA to work with the Centers of Medicare & Medicaid Services to establish a regulatory process that enables the interchangeability of biologics as well as aligns reimbursement incentives for payers, patients and providers to choose a biogeneric, CVS Caremark said.