**The entire subcommittee markup is available HERE**

**Kuster’s full remarks are available HERE**

Washington, D.C. — Today, Congresswoman Annie Kuster (NH-02), a senior member of the Energy and Commerce Health Subcommittee, successfully advanced her legislation, the Increasing Transparency In Generic Drug Applications Act of 2022. This bill was included in Section 601 of H.R. 7667, the Food and Drug Amendments of 2022 Act, and clarifies the Food and Drug Administration’s ability to provide more robust feedback to generic companies applying for Abbreviated New Drug Applications (ANDAs) and end the guessing game that delays access to cost-effective medications. This would allow lower-cost drugs to come to market faster and lower costs for Americans at the pharmacy counter.

“In New Hampshire, I hear from far too many families who are feeling the pressure of high prescription drug costs,” said Rep. Kuster. “Especially as Americans are facing higher prices at the grocery store and the pump, it is essential they have less-expensive generic options at the pharmacy. That’s why I am proud to be advancing legislation to allow lower-cost drugs to come to market faster so families in New Hampshire and across this country can afford their life-saving medications. I look forward to the full Committee reviewing this important legislation.”

Specifically, the Increasing Transparency In Generic Drug Applications Act of 2022 would:

• Require the Secretary to determine whether proposed new generic drugs are qualitatively or quantitatively the same as the listed drug.
• If it is determined that a proposed drug is not the same as the listed drug, the Secretary must inform the generic drug applicant how the proposed drug differs from the listed drug. 
• Require the Secretary to publish guidance determining whether a new drug is qualitatively or quantitatively the same as a listed drug no later than one year after enactment.

The full text of this legislation is available here.

###