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# Bill Would Prevent ANDA Blocking on 1st Generics
- URL: https://www.fdaweb.com/bill-would-prevent-anda-blocking-on-1st-generics/
- Published: 2023-03-31T12:00:00.000Z
- Updated: 2026-09-14T18:23:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154113

Senators **Tina Smith** (D-MN) and **Mike Braun** (R-IN) have reintroduced bipartisan legislation that would prevent pharmaceutical company actions to block generic drug competition through a practice called “parking.” The senators say that parking occurs when a brand company agrees not to sue the first company that submits an application to market a related generic (first filer) and enters into an agreement where this first filer agrees to delay bringing its generic drug to market. “No other company can bring a generic version of a brand name drug to market until 180 days after the first filer has done so,” [they say](https://go.politicoemail.com/?qs=b0678fb02e43d4336dccc5815403c70387984b368f58565d49d4c91aa693004d1ba7e1bba5773b6663041c25e1b714c1&ref=fdaweb.com), adding that such anti-competitive agreements allow fewer lower-cost generic products to come to market.

The lawmakers’ *Expanding Access to Low-Cost Generics Act* would attempt to solve the parking problem by:

- Allowing generic companies that are not first filers the ability to receive 180-day market exclusivity if the first filer does not come to market after a specified time-frame.
- Changing the incentive structure for generic companies so that first filers rush to come to market rather than “park” their products.
- Stopping the bottleneck of generic products waiting to come to market.

A summary of the bill can be read [here](https://smithsenate.box.com/s/lyz0za5vkjgxbvw1u8j9mfabrpw9ie4v?ref=fdaweb.com).