WASHINGTON – With unexpected drug shortages becoming the norm, the FDA needs to reallocate its resources to better handle the crisis and improve how, when and what it communicates about those shortages, a group of stakeholders told the agency.
WASHINGTON – "Just make the drugs," doctors and patients frustrated with the nation's escalating drug shortages told biopharma Monday at an FDA workshop.
WASHINGTON – Knowing it's not a full cure, lawmakers are suggesting an early warning system as a first step in treating the drug shortage epidemic facing the nation.
Regulatory certainty. It’s something industry needs and investors want to see. It’s also one of the drivers for job creation. But it’s something our government doesn’t seem to get. Take the president’s repeated call for shorter data exclusivity for biologics, beginning in 2012. Just last year, Congress made 12 years the law of the land. Changing it now is a) premature, b) unnecessary and c) absolutely pointless. As we’ve reported in BioWorld Today, the FDA is not ready to be deluged with biosimilar applications. And the biosimilar user fees that will pay for the path won’t even be in place...
The president's proposal to shorten the exclusivity period for biologics in fiscal 2012 as a debt-busting move could end up costing the government money by opening the floodgates to biosimilars long before the FDA is ready.
WASHINGTON – Biopharma's part of the tab to reduce the nation's deficit includes a shorter exclusivity for biologics, steeper Medicare rebates and stiffer penalties under President Barack Obama's proposal to trim $3.5 trillion from the debt over the next 10 years.
