As President Biden and House Democrats prepare to unveil their drug pricing game plans, 340B stakeholders eagerly await word on key provisions that could either be helpful or result in significant lost revenue. While the proposals are going to be
…
Category: Federal
U.S. House Energy & Commerce Committee Democratic leaders have sent letters to three major drug manufacturers demanding an explanation for the skyrocketing price of insulin. The E&C Committee has jurisdiction over the 340B program and plays an instrumental role on
…
340B covered entities will get none of the $75 million Bristol Myers Squibb is paying California, 27 other states, and the federal government to settle claims it underreported its average manufacturer prices (AMPs) in order to underpay Medicaid drug rebates.
…
A U.S. Supreme Court decision in late June about the appointment of federal administrative patent judges (APJs) could influence the outcome of several ongoing lawsuits over the 340B program’s administrative dispute resolution (ADR) process.
On June 21, the high court
…
Federal officials relied “on sound statutory interpretation and sufficient evidence” when it concluded in May that United Therapeutics (UT) broke the law when it conditioned access to 340B pricing on its products, government lawyers told a federal district judge in
…
Drug manufacturer AstraZeneca and the federal government each told a federal district court last Friday why it, and not the other, should prevail in Astra’s lawsuit over the government’s 340B contract pharmacy requirements.
The Aug. 6 filings were the latest
…
President Biden has nominated current White House Office of Management and Budget (OMB) General Counsel Sam Bagenstos to be the U.S. Health and Human Services Department (HHS) General Counsel—a post that has had a growing role in defending the 340B
…
President Biden this morning called on Congress to let Medicare negotiate drug prices and penalize drug companies that raise their prices faster than inflation.
Biden said lawmakers should establish a firm cap on the amount that Medicare beneficiaries have to
…
The U.S. Senate on Tuesday voted 69-30 to pass a bipartisan infrastructure bill that includes two drug pricing provisions, neither directly 340B-related. The bill now moves to the U.S. House, which is on a seven-week summer break. The $1 trillion
…
Regulations establishing a binding administrative dispute resolution (ADR) process for the 340B program were rushed into place last December to defeat lawsuits, are fatally flawed legally and constitutionally, and should be struck down, the main U.S. trade association for drug
…