From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.
On October 12, California Gov. Jerry Brown vetoed California Senate Bill 598, which had passed the State Assembly and State Senate with strong bipartisan support. If enacted, Senate Bill 598 would have allowed biosimilars approved by the FDA as interchangeable substitutes for their biological reference products, and would have required a pharmacy to notify a prescriber of the substitution.
Diane E. Bieri
In his letter vetoing the bill, Brown described the notification provision as “highly controversial.” He acknowledged that physicians would welcome this notification. However, the governor noted that CalPERS and other large purchasers of medications warned that “the [notification] requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.” Brown skirted the merits of this debate, but called the notification requirement “premature,” given that the FDA has not yet issued standards for determining when a biosimilar may be designated as “interchangeable” with its biological reference product.
To date, five other states — Florida, North Dakota, Oregon, Utah — have enacted laws defining when biosimilars may be substituted for biological reference products. Each of these laws contains a requirement that the pharmacist notify the patient, prescriber, or both regarding the substitution.
Diane E. Bieri, JD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6310; email: Diane.Bieri@aporter.com