The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”
The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, Senate Bill 17 (SB 17), which the group states is “unprecedented and unconstitutional.” PhRMA argues that the California law, set to take effect January 1, 2019, “intentionally exports California’s policy choices regarding prescription drug pricing on the entire nation.”
The law, which was signed by Democratic Governor Jerry Brown on October 9, 2017, requires drug makers to provide 60 days’ notice of price increases above 16% when combined with increases from the previous 2 years, and they must also justify those increases. In addition, insurers will have to provide information about how drug costs affect premiums.
The bill would also require the California Office of Statewide Health Planning and Development (OSHPD) to enforce the provisions requiring manufacturer reporting, and would subject a manufacturer to liability for a civil penalty if the information described above is not reported. Some of the pricing information will be available to the public on OSHPD’s website. “Californians have the right to know why their medication costs are out of control, especially when pharmaceutical profits are soaring,” Governor Brown said in a statement.
In its complaint, PhRMA argues that SB 17 “forces drug manufacturers to publicly convey and implicitly endorse the state’s position that the manufacturers are to blame for the allegedly inflated prices of prescription drugs.” Further, the group says the law incorrectly and unfairly singles out drug makers for public condemnation, and will cause market disruptions such as drug stockpiling and reduced competition. The group seeks a court declaration that the law violates the First Amendment, the Fourteenth Amendment, and the Commerce Clause.
The bill’s sponsor, State Senator Ed Hernandez, said he was confident the law would be upheld, and said the lawsuit was another example of pharma refusing to accept any responsibility for the skyrocketing costs of prescription drugs.
Analysts have noted that PhRMA is concerned that the California law has been signed because California is such a large state, and could potentially serve as a model for other states seeking to act on drug prices. Maryland and Nevada are also implementing their own drug pricing legislation. PhRMA spent nearly $17 million in the last several years to oppose SB 17 before it was signed into law.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.