Paying for Protection: Medicare Rebates May Make Protected Classes Less Safe for Sponsors

Democrats failed in their first attempt to impose price controls in Medicare Part D. But, led by California Rep. Waxman, they may have found a new approach that seems less threatening than price negotiations-rebates for products used by dual eligible patients. And the drugs most likely to be affected are in Part D's six protected classes.

Be careful what you wish for. The drug industry may want to keep that proverb in mind heading into 2009.

For any drug company playing in the Medicare Part D program, two critical developments took place in July:

More from Market Access

More from Pink Sheet

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.