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Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs

 
• By Brenda Sandburg

US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

Challenge
FDA to go forward with its current orphan drug exclusivity policy but questions remain • Source: Shutterstock

The US Food and Drug Administration has decided not to adopt the Catalyst court ruling limiting the scope of orphan drug exclusivity and instead will continue to tie exclusivity to the uses or indications for which the drug was approved rather than to the entire disease. The move leaves questions about the agency's policy unresolved and will likely lead to further litigation.

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Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 
• By Brian Bossetta and Elizabeth Orr

One CDRH employee said the cuts already are having a major effect on morale.

More from Agency Leadership

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 
• By Sarah Karlin-Smith

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."