US shutdown derided by pharma groups
pharmafile | October 7, 2013 | News story | Medical Communications, Sales and Marketing | FDA, Obamacare, PhRMA, shutdown
As the US federal shutdown enters its second week, one of pharma’s key representative bodies has warned that the FDA’s relative paralysis has ‘significant implications’.
So far, pharma companies in the US are fighting shy of saying that the country’s funding problems are damaging the industry.
But the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents pharma and biotech companies in the US, warns that restrictions in the FDA’s activities have “significant implications for human drug review activities and for the patients seeking new medicines for unmet medical needs”.
New drug applications are not being accepted for review by the FDA and the regulator will also not have user fees available to it until more legislation – called an appropriations bill – is passed.
More than 6,600 FDA staff have been sent home until the political stalemate is resolved.
The parties on Capitol Hill failed to agree a new budget for government activities next year, which left government agencies short of funds.
Republicans wanted agreement to be contingent on delays in the introduction of President Barack Obama’s health reforms under the Affordable Care Act (aka ‘Obamacare’).
PhRMA senior vice president Matthew Bennett said: “While we cannot speculate on the full impact of a government shutdown on the biopharmaceutical sector, federal agencies play a vital role in the research and development process, as well as helping ensure patients can access the medicines they need.”
The organisation will work with the agencies and government to “minimise any negative consequences a shutdown could have on patient health and access to medicines”, he added.
Estimates prior to the shutdown suggested it would cost the US economy $10 billion by this stage – but a bigger problem looms: the US Treasury has suggested its funds will run out in another week, which means the US government could begin to default on debts.
And in comments reported by the BBC, US commerce secretary Penny Pritzker has warned that business is starting to suffer.
Speaking at the Asia-Pacific Economic Cooperation meeting, she said: “The shutdown is not good for business. It’s not good for the economy.”
For one thing it means that Pritzker’s own department cannot collect economic data. “That is a problem,” she said. “It’s affecting businesses and it’s affecting their ability to get data.”
Two large US defence contractors – Lockheed Martin and United Technologies – have laid off 5,000 workers between them.
In addition to those employees at the FDA, thousands of government workers are already taking unpaid leave, including around 40,000 staff from the Department of Health and Human Services.
Media reports from India suggest that a two-week US shutdown may start to be felt in India’s pharma sector, with generics manufacturers hit by an increase in the time it takes the FDA to approve their products.
Novartis India managing director Ranjit Shahani said: “The fortunes of the domestic drug industry will be impacted as a large number of companies export over 70% to developed markets, of which US is the major buyer.”
Adam Hill
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