PILLS Act
The PILLS Act establishes two new federal tax incentives to encourage domestic production of generic drugs, biosimilars, and their essential components. First, it creates a generic drugs and biosimilars production credit (Sec. 45BB) that rewards value added in the United States when eligible components used to make approved generic drugs or licensed biosimilars are produced domestically and sold to unrelated parties. The credit rate starts at a base of 30% (with a higher 35% for final production) and can be boosted by a domestic content bonus tied to the share of US-made materials. The credit phases down after 2030. It also includes eligibility rules, documentation requirements, and protections against credits claimed for components produced at certain FDA-warning-letter facilities. Second, it creates a generic drugs and biosimilars investment credit (Sec. 48F) offering a 25% credit of the qualified investment for constructing or upgrading qualified facilities in the US to produce eligible components, with rules on what counts as qualified property, facility ownership, and a termination for projects begun after 2028 (and with the credit applicable to property placed in service after 2026). The act also provides for elective payment and transferability of these credits and makes conforming changes to other tax provisions to accommodate the new credits.
Key Points
- 1Generic drugs and biosimilars production credit (Sec. 45BB)
- 2- Tax credit for each eligible component produced in the U.S. and sold to an unrelated party in the taxable year.
- 3- Base credit percentage of 30%, increased to 35% for the final production of a drug substance, drug product, or biological product.
- 4- Domestic content bonus: credit increases by 0.20 times the domestic content percentage (up to a potential material increase). Documentation and certification rules apply.
- 5- Phase-out: credit for components sold after 2030 scales down (75% in 2031, 50% in 2032, 25% in 2033, 0% after 2033).
- 6- Eligible components include generic drugs, licensed biosimilars, and related materials used in production; excludes certain components from facilities with FDA warning letters lacking a close-out letter.
- 7- Prohibits double-crediting with certain other credits and includes regulatory guidance and definitions (e.g., what counts as “produced in the United States” and “value added”).
- 8Generic drugs and biosimilars investment credit (Sec. 48F)
- 9- 25% credit of the qualified investment for qualified facilities that produce eligible components.
- 10- Qualified property must be tangible, depreciation-allowable, constructed or acquired for use in the facility, and used as part of the facility to produce eligible components.
- 11- Qualified facility must be located in the United States and primarily produce eligible components.
- 12- Credit is limited to property placed in service after 12/31/2026; construction for property begun after 12/31/2028 does not qualify.
- 13- Includes coordination with rehabilitation credits and other tax rules; regulatory guidance required.
- 14Elective payment and credit transfer
- 15- Taxpayers may elect to treat the generic drugs and biosimilars credits as eligible for elective payment, subject to the rules for other credits.
- 16- Credits can be transferred/allocated to other entities under specified terms, with cross-references to existing transfer rules.
- 17Eligibility and definitional scope
- 18- Eligible taxpayer must not be a foreign entity of concern.
- 19- Clear definitions for “approved generic drug,” “licensed biosimilar,” “drug substance,” and “drug product.”
- 20- “Produced in the United States” defined to require all production of the component to occur in the U.S.
- 21Effective date and regulatory authority
- 22- Sec. 45BB applies to generic drugs and biologics produced after enactment.
- 23- Sec. 48F applies to property placed in service after 12/31/2026, with a construction-start cutoff of 12/31/2028.
- 24- Secretary authorized to issue regulations and guidance to implement the credits.