Contact Congress about S. 1114: Expanding Access to Low-Cost Generics Act of 2023

The FDA could let a later generic drug enter the market if the first generic has not launched after a long wait. The later company would have 75 days to start selling. The bill also gives generic makers clearer answers about inactive ingredients.

Modern Action explains what the legislation does, helps you choose whether to support, oppose, or ask for changes, and drafts a message tied to the bill, your stance, and the elected officials who can act on it.

Expanding Access to Low-Cost Generics Act of 2023 is a Senate bill in Congress.

Who this affects: This bill mainly affects generic drug companies, brand-name drug companies, the FDA, patients, pharmacies, insurers, and government health programs. Generic companies could get a clearer path to approval when an earlier filer has not launched. Patients and payers could see more generic choices sooner, but the price effect would depend on each drug market.

Why this matters: This bill matters because a first generic company can sometimes delay other generics without getting its own product to patients. The bill tries to open the door for another ready generic after a long wait. More generic competition can lower drug costs, but the effect would vary by drug. The bill also tries to reduce guesswork for generic makers by giving clearer FDA answers about inactive ingredients.

Key provisions in S. 1114

• The FDA could approve some later generic drugs even while the first generic still has its 180-day head start. The bill allows this only when specific timing and eligibility rules are met.
• The FDA must wait at least 33 months after the first generic company files its application. Only then can it use this new path for a later generic.
• A later generic company must promise it is ready to sell the drug fast. It must certify that it can and plans to start selling within 75 days after approval.
• A later company loses effective approval if it misses the launch deadline. On day 76, the approval automatically drops back to tentative approval.
• A later company cannot get another effective approval through this special path unless it explains the delay. It must certify that an unexpected event stopped timely sales and that the problem is fully fixed.

How Modern Action helps you take action on S. 1114

You do not have to start with a blank letter. Modern Action turns the bill, your position, and the relevant congressional context into a message you can edit and send. The goal is to make contacting Congress clear, specific, and useful without forcing you to parse bill text or figure out the right office on your own.

Questions people ask about S. 1114

What is S. 1114?

The FDA could let a later generic drug enter the market if the first generic has not launched after a long wait. The later company would have 75 days to start selling. The bill also gives generic makers clearer answers about inactive ingredients.

How do I support or oppose S. 1114?

Choose support, oppose, or ask for changes on Modern Action. The action flow drafts the message for you and keeps the wording tied to this bill.

Who should I contact about S. 1114?

Modern Action uses your location to route the action to the congressional offices relevant to the bill and your representation.

How does Modern Action help me act on S. 1114?

Modern Action gives you bill-specific context, lets you choose support, opposition, or changes, and drafts a message from your position and reasons.