Public Interest Organizations Call on Agencies Working to Lower Drug Prices to Oppose Proposals Threatening to Undermine their Efforts
Alex Moss | August 8, 2023
Today, we joined an alliance of public interest organizations—ACA Consumer Advocacy, Generation Patient, Patients for Affordable Drugs, Public Citizen, Public Innovation Project, Public Interest Patent Law Institute, R Street Institute, T1 International, U.S. Public Interest Research Group, and United Vision for Idaho—in letters to federal agencies, urging them to take action to prevent proposals under consideration from undermining to their efforts, and those of the entire Biden Administration, to combat the drug pricing crisis.
We are calling on the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), National Institutes of Health (NIH), Department of Veterans Affairs (VA), and Centers for Medicare & Medicaid Services (CMS) because they are directly involved in developing, approving, and paying for prescription drugs. We need their help to prevent proposals aiming to protect critical contributors to excessive drug prices: invalid patents and the brand-name pharmaceutical companies that use them to acquire and exploit undeserved monopoly power.
Regrettably, some of those proposals come from the agency that should be working to weed out invalid patents that should never have been granted: the U.S. Patent and Trademark Office (USPTO), which published a slew of concerning proposals in an Advance Notice of Proposed Rulemaking (ANPRM). Others come from Senators Chris Coons (D-DE) and Thom Tillis (R-NC), who have introduced a bill, the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, that does nothing but protect invalid patents and companies profiting from them.
If enacted, these proposals would exacerbate our country’s ongoing health care crisis, ensuring Americans continue paying more than the rest of the world for prescription drugs. To prevent that from happening, we are asking HHS, FDA, NIH, VA, and CMS to intervene in the inter-agency clearance process for the USPTO’s Proposal and in the formulation of any Statement of Administration Policy regarding the PREVAIL Act.
Our letter emphasizes
· Our support for the Biden’s Administration’s goal of lowering drug prices.
· Our concern about proposals from the USPTO and in the PREVAIL Act to restrict the accessibility and efficacy of proceedings for challenging invalid patents.
· The fact that invalid patents fuel the drug pricing crisis. Indeed, the Congressional Budget Office projected in 2015 that access restrictions less severe than those proposed now would cost taxpayers over $1 billion in higher drug prices alone.
· Real world examples showing that the patent review system facilitates the elimination of invalid patents and emergence of price-lowering competition. In one instance, the invalidation of a patent on a drug for Alzheimer’s disease led to generic competition that triggered a 75% decrease in its price.
· Particularly alarming aspects of the proposals, including restrictions that would prevent patients, researchers, and advocacy groups from challenging invalid patents, regardless of the strength of their evidence.
Hopefully, the agencies heed our call and take action to ensure the Administration’s goal of lowering drug prices can be achieved. We will be watching.