S. 1302: Increasing Transparency in Generic Drug Applications Act

This bill, known as the Increasing Transparency in Generic Drug Applications Act, aims to enhance the transparency of the process for approving generic drugs in the United States. Here are the key points of the bill:

1. Amendment to the Federal Food, Drug, and Cosmetic Act

The bill proposes amendments to Section 505(j)(3) of this act, which regulates the application process for generic drugs. Specifically, it introduces new requirements for how the Secretary of Health and Human Services will handle inquiries about the similarity of generic drugs to their branded counterparts. The main components include:

• Consultation Requests: If a person submits or intends to submit an application for a generic drug that must contain certain inactive ingredients similar to those of an existing drug, they can request information to confirm whether their drug is qualitatively and quantitatively the same as the listed (reference) drug.
• Information Disclosure: If the Secretary determines that the proposed generic drug is not qualitatively or quantitatively the same as the listed drug, they are required to disclose which specific ingredients cause this discrepancy and the extent of any quantitative differences.
• Consistency in Determinations: Once a determination is made that a generic drug is the same as the listed drug, this conclusion cannot be changed unless there has been a change in the formulation of the listed drug for safety or effectiveness reasons, or if an error in the initial determination is identified.

2. Guidance Issuance

The bill mandates that within one year of its enactment, the Secretary of Health and Human Services must publish draft guidance outlining how the determination of qualitative and quantitative sameness will be made. This guidance will:

• Specify the criteria for assessing if a drug is the same as the listed drug.
• Invite public comment for at least 60 days on the draft guidance before finalizing it.
• Require the Secretary to consider all received comments before issuing the final guidance, which should also be completed within one year of the close of the comment period.

3. Immediate Applicability

The new requirements for transparency and disclosure concerning generic drug applications will take effect as soon as the bill is enacted, regardless of when the guidance is finalized. This means that the changes will apply immediately, ensuring that the process becomes more transparent without waiting for additional regulatory frameworks.

Relevant Companies

• PFE (Pfizer Inc.) - As a major manufacturer of both branded and generic medications, changes in the approval process for generic drugs could affect their market strategy and profit margins.
• MYK (Myokardia, Inc.) - Companies developing drugs that may face generic competition could find themselves impacted by the increased clarity in the approval process.
• WBA (Walgreens Boots Alliance) - As a significant pharmacy retailer, changes in generic drug approvals could influence pricing and inventory of generic medications.