Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for c…
This bill amends section 1192(e) of the Social Security Act to create an "advanced drug product" category and extend single-source exclusivity for those products. It defines an advanced drug product as a drug using a genetically targeted technology (per FD&C Act sec. 529A(c)(2)) that can modulate gene function.
Liberty/access tradeoff: liberals emphasize patient cost impacts
Narrow, industry‑friendly tweak could attract sponsors but faces opposition from drug‑pricing critics and budget committees without offsets.
This bill amends section 1192(e) of the Social Security Act to create an "advanced drug product" category and extend single-source exclusivity for those products.
It defines an advanced drug product as a drug using a genetically targeted technology (per FD&C Act sec. 529A(c)(2)) that can modulate gene function.
For such advanced drug products, the bill increases the referenced exclusivity period to 11 years instead of the existing 7 years.
Narrow technical change favors industry but raises fiscal concerns and political opposition on drug pricing; lacks offsets or broad compromise features.
How solid the drafting looks.
Liberty/access tradeoff: liberals emphasize patient cost impacts
These are examples from the analysis, not a ranked list of the most-affected groups.
Liberty/access tradeoff: liberals emphasize patient cost impacts
Likely skeptical.
Supports incentives for novel gene therapies but worries this extends monopoly pricing and reduces access.
Concern centers on higher costs for patients and public programs without accompanying affordability safeguards.
Mixed view.
Recognizes need to incentivize risky biotech investment but worries about downstream cost and budget impacts.
Would weigh benefits against fiscal effects and seek countermeasures to protect access.
Generally favorable.
Views the bill as a narrow, pro-innovation reform reinforcing intellectual property and market incentives for cutting-edge therapies.
Sees limited federal expansion and more commercial predictability for biotech.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Narrow technical change favors industry but raises fiscal concerns and political opposition on drug pricing; lacks offsets or broad compromise features.
The bill has not accumulated any surfaced votes yet.
Liberty/access tradeoff: liberals emphasize patient cost impacts
Narrow technical change favors industry but raises fiscal concerns and political opposition on drug pricing; lacks offsets or broad comprom…
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