San Francisco Chronicle: AB 824 is supposed to make medications more affordable to Californians. It won’t.
By Wendye Robbins, M.D. | Guest Commentary in the San Francisco Chronicle
August 29, 2019
As a scientist, a biopharmaceutical entrepreneur, and an academic physician, I am particularly sensitive to the economic and accessibility burdens of prescription medications. It has been painful to watch my patients fight for drug access and affordability. This is a cause I believe in.
California legislators are considering a bill that would delay patient access to lower-cost and often lifesaving generic medicines.
AB824 is legislation that would bar companies from settling patent disputes for generic medicines by using economic “pay-for-delay” agreements with the proprietary drug’s manufacturer. These agreements are between drug makers and generic companies, and they extend the amount of time the drug maker has to provide the sole offering of a drug on the marketplace.
AB824 would reverse the burden of proof to the presumption of guilt for proprietary manufacturers. The odds of demonstrating pro-competitive value would be almost impossible.
If enacted, I believe this bill would force companies into costly lawsuits to settle patent disputes and delay less expensive generics from entering the market.
Supporters contend that the measure would cut drug prices. I think it would have the opposite effect.
Though well-meaning, AB824 would delay access to affordable generic medicines to those who need them most. By removing the ability for generic drug makers to enter into any mutually agreed upon settlement, all patent suits are subjected to a presumption standard that they are invalid. That means more litigation and longer waits for access to less-costly generic alternatives. Indeed, no settlement agreement should ever result in the delay of a generic medication to market.
The U.S. Supreme Court has said that settlements are not presumptively anti-competitive and courts can determine the value of settlements to consumers. Meanwhile, the Federal Trade Commission has the authority to review settlements on a case-by-case basis.
This route, rather than a one-size-fits-all ban on all patent settlements, is the best way to protect consumer interests. Patent settlements are an effective tool to prevent brand pharmaceutical companies from using delay tactics. They can avoid the costly and protracted litigation necessary to fight these abuses of the patent system.
Based on data from U.S. Health and Human Services, the Government Accountability Office and drug industry trend reports, generic drug prices in California decreased by an average of about 15% per year from the years 2010-2017. IQVIA, a pharmaceutical sales data and analytics provider, has found generic medicines saved consumers across the U.S. almost $2 trillion over the past decade. California patients and state programs saved $26 billion in 2018 by using generic prescription drugs.
But this bill would threaten these savings by isolating California from global markets. It is imperative that we Californians commit to lowering health-care costs and drug prices. We must also improve accessibility for patients in need.
AB824 would increase rather than decrease that burden. It would disincentivize biotech and pharma companies from investing in proprietary research and development. It would quickly impact the marketing of important medications.
For all of these reasons, I passionately encourage lawmakers to oppose AB824.
Californians deserve the opportunity for access to these affordable generic medicines in a timely manner. AB824 would make California the first state to “try out” a law that differs from federal law. Our patients can’t afford to be a test case when it comes to medication savings.
Wendye Robbins is a physician, scientist and president & CEO of Blade Therapeutics, a private biopharmaceutical company. She is an associate professor (on leave) at Stanford University School of Medicine.