The New Jersey, US-based Pharma & Biopharma Outsourcing Association (PBOA) announced its backing for the FDA Safety Over Sequestration Act, or FDA SOS Act (H.R. 1078) last week, with organisation president Gil Roth arguing that such exemption is vital.
“User fees comprise nearly half of the FDA’s budget and help the Agency reach performance milestones for regulatory review, thorough and timely inspections, and IT implementation” Roth said, adding that fees paid member companies are key to the drug development process.
The last enforced US budget cut – or sequestration – took place in October 2013 after politicians failed to agree on a budget for the following year. As a result, the US Food and Drug Administration (FDA) sent home around 4,000 staff and halted all non-essential work.
The shutdown left the FDA with a backlog of drug reviews and facility inspections that took almost a year to resolve.
According to Roth the proposed “While recent budget deals have restored cuts through FY15, the FDA SOS Act would provide a permanent fix and remove the threat and uncertainty that sequestration would create for the Agency.”
The contract manufacturing industry group – whose members include Afton Scientific, Coldstream Laboratories, Cook Pharmica, Halo Pharma, Hospira Jubilant HollisterStier, Metrics Contract Services, Patheon, Therapure Biopharma and WellSpring – is not the first organisation to show support.
The Biotechnology Industry Organization (BIO) and the Advanced Medical Technologies Association (AdvaMed) have also backed the proposal.
In 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Generic Pharmaceutical Manufacturer’s Association (GPhA) backed a similar proposal. That Bill was not approved.