Referred to the House Committee on Energy and Commerce.
Amends the Federal Food, Drug, and Cosmetic Act to let the FDA approve an abbreviated new drug application (ANDA) from a subsequent applicant when a first applicant eligible for 180-day exclusivity fails to begin commercial marketing. It creates a pathway where a subsequent applicant certifies it can market within 75 days of approval, requires at least 33 months since a first applicant’s ANDA submission, and sets rules reverting effective approval if marketing does not begin.
Progressives emphasize faster generic access and price reductions
Technically focused and potentially bipartisan but contested by brand‑name pharma; committee negotiation likely required.
Amends the Federal Food, Drug, and Cosmetic Act to let the FDA approve an abbreviated new drug application (ANDA) from a subsequent applicant when a first applicant eligible for 180-day exclusivity fails to begin commercial marketing.
It creates a pathway where a subsequent applicant certifies it can market within 75 days of approval, requires at least 33 months since a first applicant’s ANDA submission, and sets rules reverting effective approval if marketing does not begin.
The bill also adds an exception for unforeseeable events, notification timing requirements, and limits applicability to ANDAs filed after enactment without prior specified certifications.
Narrow, administrable fix improves generic access but faces organized opposition and Senate procedural barriers; modest chance absent broader vehicle.
How solid the drafting looks.
Progressives emphasize faster generic access and price reductions
These are examples from the analysis, not a ranked list of the most-affected groups.
Progressives emphasize faster generic access and price reductions
Likely favorable: the bill reduces strategic delays that keep lower-cost generics off the market, potentially expanding access and lowering drug prices.
Supporters would still expect safeguards to preserve safety and prevent gaming of the new pathway.
Cautiously supportive: the bill targets a known policy problem—delay of generic competition—while introducing procedural complexity.
A centrist will weigh patient access gains against administrative burdens and litigation risks.
Likely skeptical: while supportive of lower prices, this persona worries the bill weakens 180-day exclusivity, alters predictable IP-based incentives, and expands administrative discretion, potentially harming innovation incentives.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Narrow, administrable fix improves generic access but faces organized opposition and Senate procedural barriers; modest chance absent broader vehicle.
The bill has not accumulated any surfaced votes yet.
Progressives emphasize faster generic access and price reductions
Narrow, administrable fix improves generic access but faces organized opposition and Senate procedural barriers; modest chance absent broad…
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