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WOONSOCKET, R.I. In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy operations, Scott Reid, reiterated the company’s support that the FDA implement regulations necessary to approve biogeneric drugs under the Affordable Care Act.
“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 said. “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.”
Reid’s comments, which were made during a public hearing at the FDA’s headquarters in Silver Spring, Md., also touched on ensuring that pharmacovigilance programs for biosimilar and interchangeable products are consistent with programs for the innovator products, and that additive burdens that could inhibit patient access are not imposed on pharmacies at the front lines of managing these programs. He also urged the FDA to work with the Centers for Medicare and Medicaid Services to establish a regulatory process that not only allows for interachangeability of biologics but also aligns reimbursement incentives for payers, patients and providers to choose a biogeneric.