Dust settles on US shutdown
pharmafile | October 21, 2013 | News story | Medical Communications, Sales and Marketing | FDA, Obamacare, PhRMA, shutdown
The FDA has said that it was able to carry out a significant part of its remit during the suspension of funding which hit US government bodies and ended last week.
“FDA is pleased that the government shutdown has ended and the agency can get back to fully resuming the important work that we do every day to protect and promote the public health,” the US regulator said in a statement.
All staff are now back to work ‘at their regular schedules’, the FDA says. Thousands of employees had been forced to take unpaid leave (referred to as being ‘furloughed’) although the Agency had insisted it would be able to carry out essential work.
During the shutdown which lasted for more than two weeks, FDA activities supported by user fees continued: this meant the Agency continued to work on drug approvals, safety announcements and new indications.
In that time the US regulator gave the green light to several drugs, including Baxter Healthcare’s Clinolipid (lipid injectable emulsion, USP) – after a priority review – for intravenous feeding in adults, providing a source of calories and essential fatty acids to those unable to eat or drink.
It also approved Kaneka America Corporation’s Liposorber LA-15 System to treat paediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after kidney transplant in which there is recurrence of FSGS.
And it granted authorisation to Bayer’s Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
The FDA also continued to make safety announcements during the period that thousands of its staff were furloughed – such as on B. Braun Medical’s recall of one lot of 1g Cefepime for Injection USP and Dextrose Injection USP, which had been found to contain visible organic particulate matter which could cause inflammation.
“We are prioritising our work appropriately as we transition back to normal operations,” the Agency statement went on. “For example, we are resuming routine domestic and international inspections of regulated facilities.”
Pharmaceutical Research and Manufacturers of America (PhRMA) declined to comment on the full impact of the FDA shutdown, but had expressed concern.
Although the FDA can now accept medical product regulatory submissions for FY 2014, including submissions that require a fee payment, PhRMA said its inability to do this during the shutdown had “significant implications for human drug review activities and for the patients seeking new medicines for unmet medical needs”.
The National Institutes of Health had stopped accepting new patients for its health programmes, while the Department of Health and Human Services saw more than half of its nearly 80,000 staff sent home, but all government agencies are now back to work.
The crisis was resolved when Congress agreed a new funding package on 17 October, the date on which the US government would have potentially begun defaulting on its debts.
Adam Hill
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