PCMA Response to FDA Commissioner Scott Gottlieb’s Remarks on Biosimilars

(Washington, D.C.) — The Pharmaceutical Care Management Association (PCMA) released the following response to this morning’s remarks by Food and Drug Administration (FDA) Commissioner Scott Gottlieb:

“In an era of rising drug prices, employers, insurers and other payers have an obligation to negotiate the lowest rates available, whether for a biologic or biosimilar product.

It’s unfair to blame payers – who pay 2/3 the cost of drug benefits – for seeking the lowest costs in a marketplace where they have no control over the prices drugmakers set, how quickly FDA approves biosimilars, or when FDA will finalize workable interchangeability guidelines to increase uptake of biosimilars.

Likewise payers – not the pharmacy benefit managers (PBMs) they hire to negotiate discounts – determine how rebates and other savings are allocated to reduce premiums, out-of-pocket costs and other expenses. Increasingly, large commercial payers are requiring 100% of such rebates to be passed through to them directly.”