GPhA supports state legislation that eliminates barriers to auto substitution of biologics at the pharmacy

WASHINGTON — The Generic Pharmaceutical Association on Tuesday agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. 

 

The new compromise language includes: "Within a reasonable time following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer." According to the association, the compromise legislation GPhA supports represents an improvement over 2012 language that originally erected numerous barriers to the automatic substitution of interchangeable biologics, including pre-dispensation physician notification and written patient consent.

 

"This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines," stated Ralph Neas, GPhA president and CEO. "The compromise legislation was put forward by several GPhA members and reflects our core principles: Upholding the current pharmacy practice of automatic substitution; insisting on the science-based FDA determination of interchangeability; and treating all interchangeables and their corresponding brand biologics the same once an interchangeable is approved." 

 

GPhA expects legislation to advance automatic substitution to be introduced in many states in the upcoming 2015 legislative session. "[The legislation] must be in place to allow automatic substitution when the FDA approves the first interchangeable biologics in this country," Neas said.