To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

Bill Number

H.R. 1051

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-02-06: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-06-09T17:58:46Z

AI-Generated Summary

Purpose of the Legislation

This bill, H.R. 1051, aims to update the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enable faster approval of generic drugs by allowing subsequent applicants (companies filing later) to gain approval if the first applicant delays starting commercial sales for an extended period. The goal is to prevent delays in bringing affordable generic drugs to market while protecting incentives for initial generic developers.

Key Provisions

• Approval for Subsequent Applicants: The U.S. Food and Drug Administration (FDA, referred to as the "Secretary") can approve an abbreviated new drug application (ANDA, a streamlined application for generic drugs) from a subsequent filer if:
• The application challenges patents on the brand-name drug (via a specific certification).
• At least 33 months have passed since the first applicant's submission.
• The first applicant's approval is not blocked by other legal issues (e.g., ongoing patent disputes).
• No first applicant has yet received effective approval.
• The subsequent applicant certifies it can and intends to start selling the drug within 75 days of approval.
• 180-Day Exclusivity Adjustment: If a subsequent applicant qualifies for approval on the same day as a first applicant, the subsequent one must wait 180 days after the first starts selling before it can begin.
• Forfeiture Rule for Subsequent Applicants:
• Approval is revoked (treated as tentative) if the applicant fails to start selling within 75 days.
• The applicant can notify the FDA early if it can't meet the deadline due to unforeseen events; in such cases, it loses eligibility for future approvals under this rule unless it certifies the issue is resolved and provides proof of starting sales within one business day.
• Applicability: Changes apply only to ANDAs filed after the bill's enactment for drugs where no prior patent challenge certification was made before enactment.

Significant Changes to Existing Law

• Under current law (Hatch-Waxman Act provisions in the FD&C Act), the first ANDA filer challenging a brand-name drug's patents gets 180 days of market exclusivity to recover costs, during which no other generics can be approved. This bill introduces an exception: if the first filer doesn't act promptly (after 33 months), subsequent filers can bypass this exclusivity, provided they commit to quick market entry.
• Adds a new "special forfeiture" mechanism, which didn't exist before, to penalize subsequent filers who gain approval but delay sales, ensuring the system promotes actual market competition rather than just paperwork filings.
• Limits the changes to future filings, avoiding retroactive disruption to ongoing applications.

Potential Impacts

• On Government Agencies: The FDA may face increased administrative workload in verifying certifications, timelines, and forfeiture notifications, but it could streamline generic approvals overall, reducing backlog and enforcement of exclusivity delays.
• On Citizens: Patients and consumers could benefit from quicker availability of generic drugs, potentially lowering prescription costs and improving access to affordable medications sooner.
• On International Relations: No direct impacts; the bill focuses on domestic drug approval processes and does not address imports, exports, or foreign entities.

Main Stakeholders Affected

• Generic Drug Manufacturers: First filers may lose some exclusivity protections if they delay marketing, while subsequent filers gain opportunities to enter the market faster.
• Brand-Name Pharmaceutical Companies: Indirectly affected, as faster generic entry could erode their market share and revenue from patented drugs more quickly.
• FDA: Responsible for implementing approvals, certifications, and forfeiture rules.
• Patients and Healthcare Providers: Benefit from potential reductions in drug prices and improved supply of generics.
• Payers (e.g., Insurance Companies, Government Programs like Medicare): Could see cost savings from earlier generic competition.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Modifies the balance in the Hatch-Waxman framework (a 1984 law promoting generics via patent challenges) by addressing "evergreening" or delay tactics, where first filers secure exclusivity without timely market entry. This could lead to more litigation over what constitutes an "unforeseen event" or valid certification, but it aligns with antitrust concerns about anti-competitive delays.
• Constitutional Implications: None apparent; the bill operates within Congress's authority to regulate interstate commerce and public health under the Commerce Clause.
• Political Implications: Supports broader efforts to lower drug prices by curbing perceived abuses in generic exclusivity, potentially appealing to consumer advocates but facing opposition from generic firms relying on 180-day incentives. It reflects ongoing debates in pharmaceutical policy without introducing controversial elements like price controls.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Budzinski, Nikki [D-IL-13]

Recent Actions

• 2025-02-06: Referred to the House Committee on Energy and Commerce.
• 2025-02-06: Introduced in House
• 2025-02-06: Introduced in House

Bill Versions

• To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. — issued 2025-02-06 — PDF (7 pages)