HR1843-119

What This Bill Does

H.R.1843 amends the generic drug application review provisions in section 505(j) of the Federal Food, Drug, and Cosmetic Act. For drugs that must contain the same inactive ingredients in the same concentrations as the listed drug, or where FDA allows an in vitro bioequivalence approach tied to same inactive ingredients, FDA must tell a current or prospective abbreviated application sponsor whether the proposed drug is qualitatively and quantitatively the same as the listed drug when asked through controlled correspondence or a similar process. FDA may also provide the information during review on its own initiative. If the drug is not the same, FDA must identify the ingredient or ingredients causing the difference and disclose the amount of any quantitative deviation, notwithstanding trade secret limits because the disclosure is authorized by law. If FDA says the drug is the same, it generally may not change or rescind that determination after ANDA submission unless the listed-drug formulation changes and the old version was withdrawn for safety or effectiveness, or FDA identifies an error and provides written notice. HHS must publish draft guidance within one year, provide at least 60 days for comment, and publish final guidance within one year after the comment period closes, including guidance on pH adjusters.

Who Benefits and How

Generic drug applicants benefit from earlier FDA clarity on inactive-ingredient sameness before or during abbreviated application review. Prospective ANDA sponsors benefit because FDA must disclose which inactive ingredients differ and by how much when sameness is lacking. Patients and payers benefit if clearer FDA feedback reduces avoidable delays in lower-cost generic drug competition. Pharmaceutical formulation scientists benefit from guidance on qualitative and quantitative sameness, including pH adjusters.

Who Bears the Burden and How

The Food and Drug Administration must answer controlled-correspondence requests, disclose specified differences, and manage reliance on sameness determinations. The Department of Health and Human Services must issue draft and final guidance on the determination process. Brand drug manufacturers may face faster generic development when inactive-ingredient barriers become clearer. FDA review staff must document any later error-based change to a prior sameness determination.

Key Provisions

• Requires FDA to tell ANDA sponsors whether covered drugs are qualitatively and quantitatively the same as listed drugs.
• Requires FDA to identify differing inactive ingredients and quantitative deviations when sameness is lacking.
• Limits FDA's ability to rescind sameness determinations after abbreviated application submission.
• Requires HHS draft and final guidance on the sameness process, including pH adjusters.