Tag Archive for: HHS

With drug shortages in the U.S. not greatly improving, the Federal Trade Commission and the Department of Health and Human Services announced Wednesday that they are issuing a request for information to look at different groups involved in generic drug supply chains and evaluate how they may be contributing to persistent shortages.

The Biden administration is sending drugmakers opening offers for the U.S. Medicare program’s first ever price negotiations on Thursday, the White House said in a statement.

The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.

The U.S. government has requested that a Delaware federal judge deny an AstraZeneca motion for summary judgement in its Inflation Reduction Act case, arguing that the company’s core claims are meritless.

J&J’s pharmaceutical unit Janssen filed its complaint in U.S. District Court for the District of New Jersey. It broadly follows the other related lawsuits, arguing that the program is unconstitutional and amounts to “confiscation of constitutionally protected property.”

Previously, the CMS only covered a single round of PET imaging for patients enrolled in clinical studies. Yesterday’s proposal seeks to remove this cap and leave it up to CMS contractors to determine which patients should be covered by the health insurance program.

The U.S. government is spending over $5 billion on an effort to speed up the development of new COVID-19 vaccines and treatments, a Department of Health and Human Services (HHS) spokesperson and a Biden administration official said on Monday.

The Alzheimer’s Association has deployed 1,000 people diagnosed with, or caring for someone with the disease, to meet with all 535 members of Congress across the United States and urge them to press Medicare for early access to a new class of drugs, beginning with lecanemab, that promise to slow the disease.

The U.S. government said it would subject 27 drugs to inflation penalties, a move that will reduce out-of-pocket costs for Medicare recipients by $2 to as much as $390 per average dose.

A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), requested that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi, a prostate cancer therapeutic. March-in rights give the government the right to take a license for itself if it helped to fund the product owner’s research.