FDA Law Blog
JANUARY 18, 2023
The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities.
FDA Law Blog
NOVEMBER 16, 2021
1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)
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FDA Law Blog
MARCH 5, 2024
AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. The court found numerous flaws with this argument.
FDA Law Blog
JUNE 26, 2023
Chamber of Commerce (complaint here ), in New Jersey by Bristol Myers Squibb (complaint here ), and in Texas by Pharmaceutical Research and Manufacturers of America (PhRMA) and others (complaint here ). Since then, complaints have been filed in federal court in Ohio by the U.S.
FDA Law Blog
FEBRUARY 13, 2025
Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.
FDA Law Blog
OCTOBER 4, 2023
According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.
FDA Law Blog
NOVEMBER 16, 2021
The Act now extends that delay until January 1, 2026. In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs. The new refund requirement applies to drugs that are (1) separately paid under Medicare Part B; (2) single source drugs (i.e.,
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