The Pharmaceutical Research and Manufacturers of America (PhRMA) has initiated litigation in the United States District Court for the Eastern District of California challenging SB 17.
In its complaint, PhRMA argues that SB 17 attempts to dictate national health care policy related to drug prices in violation of the United States Constitution, singles out drug manufacturers as the sole determinant of drug costs despite the significant role many other entities play in the costs patients pay, and will cause market distortions such as drug stockpiling and reduced competition.
PhRMA seeks a declaration from the Court that certain provisions of SB 17 violate the United States Constitution and requests that the Court permanently enjoin the State from implementing or enforcing those provisions of the law. Specifically, the complaint alleges that SB 17 violates:
- the Commerce Clause, which prohibits California from regulating drug pricing beyond the State’s borders;
- the First Amendment, by compelling speech by manufacturers justifying their price changes; and
- the Fourteenth Amendment’s due process clause because the law is unconstitutionally vague.
“In this time of great innovation and advancement in therapies, we understand how important it is for patients to have affordable access to the medicines they need, but SB 17 is not only poorly conceived, it also misses the mark with its myopic focus on manufacturers and provisions that are in clear violation of the Constitution,” said James C. Stansel, PhRMA Executive Vice President and General Counsel. “The law creates bureaucracy, thwarts private market competition, and ignores the role of insurers, pharmacy benefit managers and hospitals in what patients pay for their medicines.”
SB 17 provides that if a manufacturer has increased certain products’ federally defined nationwide list price (wholesale acquisition cost, or WAC) by 16 percent or more cumulatively over the prior two to three calendar years, then that company may not increase the WAC in the current calendar year unless the company first provides registered purchasers and State purchasers with 60 days’ advance notice of the price increase. The WAC is a publicly available national price, not a price specific to California. This law, therefore, expressly saddles the entire country with California’s drug pricing policy by imposing restrictions on the national list price of manufacturers’ medicines.
PhRMA also claims the law does not address the large rebates and discounts insurance companies and pharmacy benefit managers (PBMs) are receiving and that are not always passed on to patients. Further, the advance notice requirement could incentivize prescription-drug arbitrage by effectively creating a “buying window” for selected entities to stockpile products before price increases go into effect, which in turn could create substantial market distortions.