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.

House Votes

This bill changes how the FDA handles the “first generic” spot. Today, when the first generic drug qualifies, it gets 180 days alone on the market once it starts selling. The bill lets the FDA approve another ready generic if the first one still isn’t selling, but only if strict conditions are met, like promising to start selling within 75 days and meeting timing and patent-related checks.

If the alternate company doesn’t start selling within 75 days after approval, its approval turns temporary. It loses that effective approval unless it shows an unexpected problem caused the delay and that the problem is now fixed. It must also tell the FDA as soon as it begins selling the drug.

• Who is affected: The FDA and companies that make generic drugs.
• What changes:
  • The FDA may approve a different generic if the first one hasn’t launched, as long as the new company is fully ready and promises to start selling within 75 days.
  • At least 33 months must have passed since a first company filed for that drug, and patent lawsuits cannot be the reason the first company can’t be approved; no first company can already have an effective approval that day.
  • Missing the 75-day launch window makes the approval temporary, with a narrow path to regain it only if an unforeseen issue caused the delay and is resolved; the company must notify when it begins selling.
• When: Applies to new generic applications filed after this becomes law, not to older applications already in the pipeline.