Sen. Charles Schumer, D-NY, is in favor of exempting biopharma companies from the Patent and Trademark Office's inter partes review proceedings. However, he said industry may have to be content with modifying the process if legislators are unable to find $1.2bn in pharma-related cost savings.
Pharma's Preferred Patent Reforms May Be Too Expensive
Sen. Schumer supports exempting Rx industry from inter partes review, but tells BIO conference that legislators must find $1.2 billion to enact it; calls for industry code of conduct on pricing.
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Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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.
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.
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Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
One CDRH employee said the cuts already are having a major effect on morale.
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.