CLSA Expresses Concerns to Congressional Delegation on “March-In Rights”

Feb. 6, 2016

Last month, Rep. Lloyd Doggett (D-Texas) led a letter asking the U.S. Department of Health & Human Services (HHS) and the National Institutes of Health (NIH) to assert “march-in rights” to address the issue of prescription drug costs and access.  Unfortunately, 13 members of the California Congressional Delegation offered their support of this letter, including Reps. Karen Bass (D-Los Angeles), Xavier Becerra (D-Los Angeles), Judy Chu (D-Pasadena), Mark DeSaulnier (D-Walnut Creek), Sam Farr (D-Monterey), John Garamendi (D-Davis), Janice Hahn (D-Carson), Jared Huffman (D-San Rafael), Barbara Lee (D-Oakland), Grace Napolitano (D-El Monte), Lucille Roybal-Allard (D-Commerce), Raul Ruiz, MD (D-Palm Desert), and Maxine Waters (D-Los Angeles).

In response, CLSA has been meeting with offices who cosigned the Doggett letter, advising them of our concerns about the letter’s position on march-in and explaining the dangerous impact that such a policy would have on future biomedical investment and innovation.

More specifically, as outlined in a CLSA letter shared with each office, asserting march-in rights based on price would go against the very aim of the Bayh-Dole Act, which is to enable the development and commercialization of new treatments and cures emanating from discoveries made in institutions of higher learning by stimulating the transfer of technology in order to get innovative medicines and therapies to patients’ bedsides.

As stated in our letter, the march-in provisions of the Bayh-Dole Act were intended to be used in very limited circumstances by federal funding agencies, such as if the grantee or licensee to a patent “has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention.” March-in provisions were certainly not intended to be exercised by agencies to address issues concerning drug pricing, and were not intended to act as a price control mechanism for biopharmaceuticals or any other technologies derived from federally-funded research.

Using the march-in provisions to justify implementing drug price control mechanisms is just the latest in a series of strategies legislators are using to respond to the current drug pricing debate.  CLSA’s federal government relations team is focusing its spring advocacy activities on engaging with members and staff of our congressional delegation to highlight our Value of Innovation campaign, and to provide data on the value and long-term cost-savings California’s innovative life sciences ecosystem provides to patients, the healthcare system and the overall economy.

For questions, please contact Jenny Carey, CLSA’s Director of Federal Government Relations and Alliance Development (