Despite Narrow Confirmation, Associations Praise New FDA Commissioner Califf

Pharmacy benefit manager and biosimilar/generic manufacturer associations praised the confirmation of Dr. Robert Califf to lead the Food and Drug Administration (FDA).

Manuel Balce Ceneta/Associated Press

Califf was narrowly confirmed as the new FDA commissioner by the Senate in a 50-to-46 vote on February 15.

Some senators voted against confirming Califf due to his prior work with the pharmaceutical industry, the FDA’s easing of restrictions on the abortion pill when he previously served as commissioner, and what they called the FDA’s lax record on opioids, per The Washington Post.

Califf has refused “to distance himself from the FDA decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” Senator Steve Daines (R-MT) said before the vote.

However, several industry groups said they are looking forward to working with Califf on lowering prescription drug costs and on policies that favor biosimilar and generic medications.

“The members of the Biosimilars Forum and I congratulate Dr. Califf on his confirmation as the next FDA commissioner,” said Juliana Reed, executive director of the Biosimilar Forum, in a statement.

“Biosimilars are critical to lowering drug prices for all Americans, and our nation can achieve billions in healthcare savings by increasing biosimilar adoption and access. The Forum calls on President Biden, Congress, and the new FDA commissioner to work together to advance biosimilars and lower prescription drug costs,” Reed added.

Eight in 10 Americans say prescription drug costs are unreasonably high, and biosimilars “must be seen as mission-critical to decreasing these costs,” Reed told FormularyWatch®. “The need for biosimilars cannot be ignored, and the FDA plays a critical role in this.”

The FDA and Dr. Califf must deem biosimilars as indispensable to lowering drug costs, and timely virtual inspections must be conducted because patients need lower cost medicines and biosimilars will provide this, Reed added.

Meanwhile, the Pharmaceutical Care Management Association said in a statement emailed to FormularyWatch® that it looks forward to working with Califf and the FDA on ways to reduce prescription drug costs for patients.

“Increased competition in the prescription drug marketplace is important to achieving the shared goal of increasing affordability and access to prescription drugs,” PCMA said.