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Voices From The Bench: Supreme Court Justices Probe The Affordable Care Act

 
• By Scott Steinke

“The Pink Sheet” highlights intriguing, and perhaps telling, comments by U.S. Supreme Court justices from three days of oral arguments pertaining to the constitutionality of the Affordable Care Act, including the constitutionality of the “individual mandate” for insurance coverage, its severability from other ACA provisions, and whether new Medicaid requirements are an unconstitutional coercion of the states.

The U.S. Supreme Court has concluded three days of oral arguments pertaining to two cases challenging the constitutionality of the Patient Protection and Affordable Care Act (ACA), one brought by 26 states and one by the National Federation of Independent Business. The main issues of interest for the pharmaceutical industry – and a major reason the industry supported passage of the health reform law – are provisions for a major expansion of individuals covered by some form of health insurance Also see "If States Win Lawsuits Against Health Reform Law, How Might Pharma Fare?" - Pink Sheet, 25 October, 2010.. These were topics of the court’s oral arguments March 27 and 28.

Approximately 30 million now uninsured individuals are projected to gain coverage under ACA in its current form, through such mechanisms as a higher income threshold for Medicaid eligibility, state-based health insurance exchanges and an “individual mandate”

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.