In a speech at the Food and Drug Law Institute Annual conference, FDA commissioner, Gottlieb said the U.S. doesn't have a "truly free market" when it comes to drug prices.
He suggested that the federal government should re-examine whether drug rebates, which manufacturers pay to pharmacy benefit managers and insurers in exchange for more favorable coverage of their products, should be exempt from an anti-kickback law.
He suggested that the federal government should re-examine whether drug rebates, which manufacturers pay to pharmacy benefit managers and insurers in exchange for more favorable coverage of their products, should be exempt from an anti-kickback law.
"Such a step could restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition," Gottlieb said.
The anti-kickback statute makes it illegal to offer remuneration in exchange for health-care services or products reimbursable by a federal health-care program. A change along the lines of what Gottlieb suggested could mean the government could impose fines or threaten other legal action "to force changes in the rebate system."
That is one step.
