What changed between these versions
A substantive expansion and several technical adjustments. v2 introduces a new section focused on the regulation of certain nonprescription drugs, expanding who can receive FDA development advice. It also includes minor clarifications to definitions and reallocates direct cost adjustments for future fiscal years.
Overview
v2 includes a new substantive section and several targeted modifications to existing provisions related to user fee calculations and definitions. The changes are not extensive throughout the entire bill but are concentrated in specific areas. · v2 expands the scope of engagement with the FDA for nonprescription drug development and clarifies certain administrative and financial parameters of the user fee program, while maintaining its core structure.
The most significant change in v2 is the addition of a new Section 6, which addresses the regulation of certain nonprescription drugs marketed without an approved drug application. This new section expands the scope of entities that can receive development advice from the FDA and includes a technical correction to a definition. Additionally, v2 clarifies the specific agency website for guidance on voluntary consensus standards, updates the geographic area for inflation adjustment, and reallocates a $30,000 direct cost adjustment between fiscal years 2029 and 2030. The core framework for user fee assessment and collection remains consistent with v1.
Major additions
This entirely new section, titled 'Regulation of Certain Nonprescription Drugs That Are Marketed Without An Approved Drug Application,' introduces amendments to Section 505G of the Federal Food, Drug, and Cosmetic Act. It specifically modifies who can receive development advice from the Food and Drug Administration and makes a technical correction to a related definition concerning sponsors and requestors.
The addition of this section broadens the scope of engagement with the FDA for nonprescription drug development, allowing organizations representing sponsors or requestors to participate in advice proceedings. This could streamline communication and potentially accelerate development processes for relevant stakeholders.
Modifications
This modification provides greater clarity and specificity for stakeholders seeking information on recognized voluntary consensus standards, ensuring they know precisely where to find the relevant guidance on the Food and Drug Administration's official website, reducing potential confusion.
Before
v1 stated that recognized voluntary consensus standards for pharmaceutical quality should be 'publicly available on the agency website'.
After
v2 specifies that these standards should be 'publicly available on the website of the Food and Drug Administration'.
This modification streamlines the calculation method for the inflation adjustment percentage by removing redundant phrasing and re-indexing the components. While not changing the underlying calculation, it improves the clarity and conciseness of the statutory language, affecting all future fee calculations.
Before
v1's inflation adjustment percentage calculation included a stricken clause (i) and then redesignated subclauses (I) and (II) of clause (ii) as clauses (i) and (ii) respectively, after striking redundant introductory text.
After
v2 maintains the same structural changes, striking clause (i) and redesignating subclauses (I) and (II) of clause (ii) as clauses (i) and (ii) respectively, and striking the introductory text 'for each of fiscal years 2024 and 2025, the sum of--'.
This change updates the geographic area used for calculating the inflation adjustment percentage for user fees. While potentially a minor adjustment, it ensures that the fee calculations are based on the most current and precise regional economic data, which could lead to slight variations in the annual fee amounts for all regulated entities.
Before
v1 used 'Washington-Baltimore, DC-MD-VA-WV' as the Consumer Price Index (CPI) area for inflation adjustment calculations.
After
v2 updates this to 'Washington-Arlington-Alexandria-DC-VA-MD-WV'.
This modification shifts a $30,000 direct cost adjustment from fiscal year 2030 to fiscal year 2029. This will result in a higher total facility fee revenue for FY2029 and a lower one for FY2030, directly impacting the financial obligations of OTC monograph drug facilities in those specific years.
Before
v1 allocated $0 for additional direct cost adjustments for fiscal year 2029 and $30,000 for fiscal year 2030.
After
v2 reallocates these amounts, assigning $30,000 for fiscal year 2029 and $0 for fiscal year 2030.
This change expands the pool of entities that can directly engage with the FDA for development advice, potentially enabling industry associations or other representative bodies to act on behalf of multiple sponsors or requestors, thereby streamlining the advisory process and reducing individual administrative burdens.
Before
In v1, Section 505G(h) implicitly limited those who could receive development advice from the Secretary to 'sponsors or requestors' of OTC monograph drugs.
After
In v2, Section 505G(h) is amended to explicitly allow 'sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding' to receive development advice.
This technical correction ensures that both sponsors and requestors are explicitly covered by the specified provision, removing any ambiguity and aligning the language with the broader intent of the user fee program, ensuring consistent application of the law.
Before
In v1, Section 505G(b)(2)(A)(iv)(III) referred only to 'requestors' in a specific context related to nonprescription drugs.
After
In v2, Section 505G(b)(2)(A)(iv)(III) is amended to refer to 'sponsors or requestors,' clarifying the scope of the provision.
Scope
Meaningful expansion or narrowing — Changes are concentrated in a newly added section and specific subsections related to fee adjustments and definitions, rather than being scattered throughout every part of the bill. — v2 introduces a new policy area regarding development advice for nonprescription drugs, representing a slight expansion of regulatory engagement, while maintaining the core policy direction of the user fee program. — The new section introduces provisions that interact with existing regulatory frameworks for nonprescription drugs, specifically by expanding who can engage with the FDA for development advice. Other changes are confined to specific fee calculation parameters and definitions.
Impact analysis
Sponsors and requestors of OTC monograph drugs, and organizations representing them.
Gain (increased flexibility and representation).
These groups can now nominate organizations to represent their interests in development advice proceedings with the FDA, whereas previously only individual sponsors or requestors were explicitly mentioned.
OTC monograph drug facilities subject to user fees.
Procedural change (timing of financial obligation shifted).
The allocation of a $30,000 additional direct cost adjustment has been shifted from fiscal year 2030 to fiscal year 2029.
Stakeholders seeking guidance on voluntary consensus standards for pharmaceutical quality.
Procedural change (improved clarity for information access).
The specific location for publicly available guidance on recognized voluntary consensus standards has been clarified from 'agency website' to 'website of the Food and Drug Administration'.
All entities whose user fees are subject to inflation adjustments based on the specified CPI area.
Procedural change (updated methodology for fee calculation).
The specific geographic definition for the Consumer Price Index (CPI) used in inflation adjustments has been updated.