Washington, D.C.—U.S. Senator Susan Collins, the Ranking Member of the Subcommittee on Primary Health and Retirement Security, participated in a hearing today on strategies to improve prescription drug affordability.
“When a doctor prescribes a needed medication, an insurmountable barrier to taking that should not be its cost,” Senator Collins said in her opening remarks. “More than half of Americans, and an overwhelming majority of our seniors, take at least one prescription drug each month. For many, access to these medicines not only is critical to their well-being, but it also can literally be a matter of life or death.”
Increasing generic and biosimilar competition has been a longtime priority for Senator Collins. During today’s hearing, Senator Collins highlighted how some pharmaceutical companies abuse the patent system to prevent low-cost alternatives from entering the market.
As an example of this strategy, Senator Collins noted that the pharmaceutical company AbbVie filed 247 patent applications for Humira. There are several lower-cost biosimilars available for sale in the European Union, but because of an aggressive patent litigation strategy, American patients must wait an additional two years for them to be available here.
Senator Collins asked Alex Brill, a resident fellow at the American Enterprise Institute, how Congress could take aim at the abuse of the patent system while ensuring that innovative scientific breakthroughs are still encouraged and rewarded.
“We have these pathways through the FDA to create and foster generic competition, biosimilar competition, and the patent system is getting in the way,” Mr. Brill responded. He went on to stress the need to enact legislation, “to protect core patents and appropriate patents, but to block or prevent the ability of innovators to stack patents on top of each other and create undue, unnecessary, excessive monopoly powers for their products.”
Senator Collins also questioned Dr. Aaron Kesselheim, a Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School, about how the broader use of drug price negotiation by the federal government would work in practice. She explained that the Veterans Administration has some authority to negotiate favorable pricing, but veterans often experience difficulty and frustration if they need a drug that is not available on that formulary.
Senator Collins asked, “Under a national formulary, how do we ensure physicians can still prescribe the medications that are best suited for them?”
Dr. Kesselheim replied that a guiding principle of a national formulary would be “evaluating the effectiveness of drugs and negotiating on that basis, and not necessarily about restricting access to the products, but providing coverage to products that are extremely effective, and not providing the same level of coverage to products that don't offer the same thing, that don't offer additional benefits.”
In 2015, Senator Collins and then-Senator Claire McCaskill (D-MO) launched the Senate’s first bipartisan investigation into the causes, impacts, and potential solutions to egregious price spikes for certain off-patent drugs. Over the course of 10 hearings, the Committee examined patient hardships in affording prescription drugs, investigated the complex system that leads to high drug prices, and identified ways to bring costs down for older Americans. The Committee released a report on its investigation in 2016. Following their investigation, Senators Collins and McCaskill authored a bill to improve generic competition and lower the cost of prescription drugs that was signed into law as part of the FDA Reauthorization Act. In October 2018, Senator Collins’ legislation to prohibit the use of pharmacy “gag clauses” was signed into law.
In 2019, Senator Collins introduced the Biologic Patent Transparency Act to help block the harmful patent strategies that prevent lower-cost biosimilars from coming to market. In July 2019, Senators Collins and Jeanne Shaheen (D-NH), the co-chairs of the Senate Diabetes Caucus, introduced new legislation to combat the skyrocketing cost of insulin.
Additionally, last Congress, Senator Collins joined a group of Senators in introducing the Prescription Drug Pricing Reduction Act of 2020, landmark legislation that would save taxpayers more than $95 billion, reduce out-of-pocket spending by $72 billion, and reduce premiums by $1 billion. This bill would take a pragmatic approach to prescription drug reform, focusing on creating penalties for drug price increases that outpace inflation and eliminating opportunities for “middlemen” like pharmacy benefit managers to drive up prices for patients and taxpayers.