Generic / Large Molecule

FDA says PBMs are "complacent participants" in biosim delays

Apr 20, 2018

FDA Commissioner Scott Gottlieb accused pharmacy benefit managers of being "complacent participants" in drugmaker schemes that restrict biosimilar and generic competition.

While speaking at the Pharmaceutical Care Management Association's PBM Policy Forum this week, Gottlieb noted the agency’s concern that, given changing payor and insurer dynamics, the full benefits of competition are still not reaching patients and consumers.

“To date, we’ve approved nine biosimilar products, but only three are available in the U.S. In some cases, patent thickets on biologics deter market entry for years after FDA approval. In other cases, restrictive contracting, rebating, and distribution agreements deter coverage and reimbursement,” said Gottlieb in a prepared statement.

Although they may not be aware of it, more than 80 percent of the U.S. population have their drug benefits managed by PBMs. Gottlieb said he is not looking “to point fingers” and encouraged PMBs to recognize their role in the solving America's prescription drug pricing problems.

To that end, Gottlieb encouraged PBMs who own specialty pharmacies or distributors to crackdown on the restrictive contracting and distribution strategies manufacturers use to prevent generic and biosimilar sponsors from securing product samples.

According to Gottlieb, the agency will soon be releasing a final guidance on communication of pharmaco-economic information between manufacturers and sophisticated intermediaries like PBMs and hospital-based pharmacy and therapeutics committees.

Read our recent cover story on the generic industry battle