On February 3, 2026, President Trump signed H.R.7148, the Consolidated Appropriations Act, 2026, into law. Section 6703 of the Act, “Increasing Transparency in Generic Drug Applications,” amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide more specific feedback on whether a proposed generic drug product is qualitatively and quantitatively (Q1/Q2) the same as the listed drug.
Effective immediately, upon request submitted through controlled correspondence, the FDA must inform the applicant whether the proposed generic drug is Q1/Q2 the same as the listed drug. If the FDA determines the proposed generic drug is not Q1/Q2 the same as the listed drug, the FDA must identify the inactive ingredients that create the difference and, for any ingredient with a quantitative deviation, disclose the amount of the deviation.
For abbreviated new drug application (ANDA) applicants, particularly those developing complex generic products, this change addresses a long-standing source of development uncertainty. Q1/Q2 sameness is often the first and most consequential question in formulation development for parenteral, ophthalmic, and otic products, and the FDA’s feedback at this stage can determine whether a development program proceeds or stalls.
Historically, the FDA’s responses to applicant inquiries into Q1/Q2 sameness were constrained by statutory and regulatory protections for trade secrets and confidential commercial information. As a result, feedback was typically limited to a binary determination: whether a proposed formulation was or was not Q1/Q2 the same as the listed drug. Sponsors were left to infer the underlying reason through reverse engineering and iterative exchanges with the FDA. This approach increased the development burden for applicants and administrative workload for the agency.
The new law shifts this dynamic by expressly authorizing the FDA to provide formulation-specific information that previously could not be disclosed. By requiring the FDA to identify the specific ingredient differences and the extent of any quantitative deviation, Congress has moved Q1/Q2 assessment from a binary outcome toward a more transparent, actionable regulatory dialogue. ANDA applicants can now expect greater clarity earlier in development, which may support informed formulation decisions, targeted regulatory engagement, and efficient allocation of development resources.
The law expressly limits the FDA’s disclosure authority to identifying the ingredient for Q1/Q2 difference and the amount of any quantitative deviation. It further makes clear that it does not otherwise permit disclosure of nonpublic formulation information for listed drugs or alter the treatment of that information as trade secrets or confidential commercial information.
Congress also directed the FDA to issue draft guidance within one year describing how the FDA will determine Q1/Q2 sameness under the new statutory provision. Notably, the statute is effective immediately regardless of the timing of that guidance. Therefore, ANDA applicants may immediately begin requesting Q1/Q2 assessments through controlled correspondence and expect the FDA to provide more detailed feedback.
We are closely monitoring the FDA’s implementation of these provisions and advising clients on how to incorporate this increased transparency into ANDA’s formulation development and regulatory strategy.
If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Drug & Device team.
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