FDA launches online transparency initiative
pharmafile | January 11, 2011 | News story | Medical Communications, Research and Development, Sales and Marketing | FDA, Joshua Sharfstein, transparency
The FDA has launched a new online resource to increase the transparency of its processes and help save companies time and resources when they work with the agency.
The FDA Basics for Industry includes basic information about the regulatory process, including information the US regulator says is frequently requested by pharma companies.
The site will make FDA presentations more widely available and build on a commitment that all mail questions involving regulatory process will receive an answer within five business days.
FDA commissioner Margaret Hamburg, said: “Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health.
“In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates,” she added.
The launch follows the publication of a new report ‘FDA Transparency Initiative: Improving Transparency to Regulated Industry’.
Produced by a ‘transparency taskforce’ created in 2009 in response to President Obama’s commitment to openness in government, the report also contains five draft proposals that aim to improve FDA’s transparency to regulated industry.
These include publishing a timeline online for high priority guidance documents in development, and disclosing dates for the publication of the draft guidance, receipt of public comments and publication of final guidance.
Principal deputy commissioner Joshua Sharfstein, chairman of the agency’s transparency task force, said: “We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications.”
The new web resource can be found on the FDA’s official website.
Sharfstein exits FDA
Meanwhile, this will be the last announcement made by the FDA’s second-in-command as Sharfstein has decided to leave the FDA after only 21 months in post to become the head of public health in the state of Maryland.
Sharfstein has been a fierce critic of pharma and, since his appointment to the FDA in 2009, has sought to increase regulation and follow through on civil and criminal actions.
His move is believed to be linked to the changing balance of power in the US House of Representatives, which is now controlled by the more industry-friendly Republicans.
Ben Adams
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