U.S. Senator Rand Paul | U.S. Senator Rand Paul official website
U.S. Senator Rand Paul | U.S. Senator Rand Paul official website
U.S. Senator Rand Paul (R-KY) has joined forces with U.S. Senator Bill Cassidy, M.D. (R-LA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, along with 15 other Republican Senators, to express their opposition to President Biden's proposal that could potentially allow the seizure of drug patents under the Bayh-Dole Act. The Senators raised their concerns in a letter addressed to NIH Director Monica Bertagnolli, M.D.
According to the original authors of the Bayh-Dole Act, former U.S. Senators Birch Bayh (D-IN) and Bob Dole (R-KS), the legislation was not intended to empower the government to set prices on resulting products. They emphasized that the law does not mention any government-dictated reasonable price.
During her nomination hearing, Dr. Bertagnolli affirmed that she would "follow all the laws of our land" when asked about supporting the use of march-in rights to influence drug costs. Both Republican and Democratic presidential administrations in the past have reiterated that agencies do not possess the authority to seize patents under Bayh-Dole in response to commercial drug costs.
The proposed use of march-in rights based on drug prices has raised concerns about its potential negative impacts on the development of new cures and treatments. The Bayh-Dole Coalition noted that such actions could deter critical public-private partnerships and hinder the delivery of groundbreaking discoveries to consumers. Universities and research institutions, where the majority of NIH-funded research occurs, have criticized march-in rights as an ineffective mechanism to lower drug prices that could undermine innovation.
The Senators emphasized that the misuse of march-in rights could impede healthcare innovation and deprive millions of Americans of future lifesaving treatments. In their letter to NIH Director Bertagnolli, they warned that exercising march-in rights would not only harm patients but also diminish the return on Congress's investments in NIH.
In a united front, the Senators stated, "We share the bipartisan goal of wanting to lower drug prices for American patients and families. But using march-in rights to address drug prices would do more harm than good." They urged agencies, including the NIH, to refrain from abusing their authorities to seize intellectual property illegally and jeopardize valuable public-private partnerships crucial for biomedical research.
Dr. Paul and Dr. Cassidy were joined by a group of Republican Senators in their opposition to the Biden proposal. The full letter addressed to NIH Director Monica Bertagnolli can be accessed on Senator Rand Paul's website.