HR 1672
Maintaining Investments in New Innovation Act
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Bill overview
This bill, the Maintaining Investments in New Innovation Act, changes the requirements for certain prescription drugs to be included in Medicare’s drug price negotiation program. Specifically, it extends the market approval time needed for drugs to qualify from 7 years to 11 years. This change applies to drugs that utilize genetically targeted technologies, a category defined by the Food and Drug Administration. The goal is to protect access to innovative medicines that rely on these advanced technologies.
Key provisions
- Extends the market approval time for drug price negotiation from 7 to 11 years.
- Applies this extension to drugs utilizing genetically targeted technologies.
- Defines ‘advanced drug product’ as a drug incorporating genetically targeted technology.
- Modifies Section 1192(e) of the Social Security Act to reflect the extended approval period.
Who is affected
- Medicare beneficiaries
- Pharmaceutical companies
- Drug manufacturers
- The Centers for Medicare & Medicaid Services
Notable changes
- Increases the market approval time requirement for drugs in the Medicare drug price negotiation program.
- Creates a specific category of ‘advanced drug products’ subject to the longer approval period.
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119th CONGRESS — 1st Session
H. R. 1672
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend title XI of the Social Security Act to protect access to genetically targeted technologies.
This Act may be cited as the Maintaining Investments in New Innovation Act
.
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—
in paragraph (1)(A)(ii), by inserting (or, in the case of an advanced drug product (as defined in paragraph (4)), 11 years)
after 7 years
; and
by adding at the end the following new paragraph:
For purposes of paragraph (1)(A)(ii), the term advanced drug product means a drug that incorporates or utilizes a genetically targeted technology (as defined in section 529A(c)(2) of the Federal Food, Drug, and Cosmetic Act) that may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product.