“Patients, payers and the government all lose when some brand manufacturers misuse FDA safety protocols to withhold samples from generic and biosimilar drugmakers, which delays market competition and keeps drug prices artificially high. Sample medicines are needed by the generic and biosimilar companies to conduct product development and bioequivalence studies necessary for FDA approval. The CREATES Act, a bipartisan bill before Congress to end these abuses by some brand companies is supported by AAM, PCMA and others in the supply chain.
It is also worth noting however, even after generics are approved by FDA, these more affordable medicines often face additional hurdles on their way to patients in the form of exclusive commercial contracts between brand manufacturers and certain payers that can limit patient access and savings.”
CONTACT:
Rachel Schwartz
202.249.7147 (o)
202.251.8881 (c)