Chairman Arrington, Health Care Task Force Chair Burgess Lead Letter to CBO on IRA Drug Development Analysis | The United States House Budget Committee – House Budget Committee

November 20, 2023

WASHINGTON, DC – House Budget Committee Chairman Jodey Arrington (R-TX) and House Budget Committee Health Care Task Force Chairman Michael C. Burgess, MD (R-TX) led a letter to director Phillip Swagel of the nonpartisan Congressional Budget Office (CBO) asked the CBO for answers. analysis of policies impacting drug development in the United States.

Joined by members of the Budget Committee Health Care Task Force (HCTF) Rep. Lloyd Smucker (R-PA), Rep. Buddy Carter (R-GA), Rep. Blake Moore (R-UT), Rep. Rudy Yakym (R-IN) ), Rep. Drew Ferguson (R-GA), and Rep. Chip Roy (R-TX), the letter seeks more information on how the CBO analyzed the impact of the Inflation Reduction Act ( IRA) drug price controls on patient access. new drugs in the United States.

The letter reads in part, “CBO’s analysis suggested that the IRA would result in one fewer drug coming to the US market in 2023-2032, about five in the next decade, and about seven in the decade after that, for a total of 13 fewer drugs coming to market in the next 30 years. Independent evaluations and related studies have suggested that a significantly higher number of new drugs are not brought to the US market because of l ‘implementation of the law…’

“With the growing impact of health care costs on the federal budget, we appreciate that CBO is recognizing the power of innovation to reduce health care costs. We fear that the loss of innovation and new treatments reaching patients through IRA price controls will lead to one less tool that could reduce federal health care spending in the future.”

“Consequently, it is increasingly important that CBO’s analysis of policies that impact drug development in the United States incorporate the most recent and accurate information to ensure that decision makers are fully aware of the impact that the legislation will have on patient access to new drugs.”

The letter asks CBO to answer several questions with the goal of better understanding CBO’s current approach to analyzing policies that impact patient access to new drugs in the United States, including:

1. CBO shared that the drug development model has been continuously updated based on additional information and feedback from stakeholders and independent experts. Since the passage of the IRA, numerous biopharmaceutical companies, investment funds and financial institutions have made public statements about the impact of the IRA on clinical development decisions and investment strategies. Is CBO following trends in investments in early-stage drug development by venture capital firms after the passage of the IRA? Are there additional updates or changes that CBO is currently considering to the drug development model?
2. Is CBO working, or willing to work, to expand the drug development model to forecast the impact of related policies on the total number of post-approval indications collected by drugs that come to the market or the different impact in specific therapeutic areas? CBO intends to incorporate the impact of not only overall drug discovery, but the likelihood of companies moving away from small molecule indications, as well as the likelihood of companies moving to the indications who target a population outside the average Medicare age?
3. CBO has changed, or considered reevaluating, its assessment of the impact of the IRA as a result of actions the Centers for Medicare and Medicaid Services (CMS) has taken to implement the law since enactment ? In particular, the selection of drugs with future biosimilar and generic competition as part of the top ten drugs in the drug price negotiation program alters CBO’s expectations regarding reductions in budget expenditures attributable to the IRA?
4. CBO recently published a blog post asking for feedback on new research on the use of anti-obesity medications to help inform the agency’s analysis of relevant policies. Will CBO commit to issuing a similar blog post asking for independent feedback on new research and data to help inform potential refinements and improvements to the drug development model?

Backgrounds:

The letter follows the inaugural HCTF roundtable discussion with CBO Director Swagel last month, which brought together independent experts and stakeholders to examine CBO’s underlying model and analysis of IRA’s impact on the development of new drugs in the United States.

Pictured from left to right at table: Chairman Jodey Arrington (R-TX), Representative Rudy Yakym (R-IN), CBO Director Phillip Swagel, HCTF Chairman Michael C. Burgess (R-TX), Chairman of the American Action Forum and former CBO. Director Doug Holtz-Eakin

The HCTF looks forward to continuing to work in a collaborative and constructive manner with CBO to ensure that policymakers have access to the best available analysis when making policy decisions.

Click HERE for the full letter.