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FDA to improve transparency

Published on 03/06/09 at 05:07pm

The US medicines regulator is to boost the transparency around its decision-making, in connection with President Obama's aim to make government bodies more open.

The Food and Drug Administration (FDA) said it would create a task force to develop recommendations for enhancing the transparency of its operations and decision-making process.

New FDA commissioner Dr Margaret Hamburg said: "President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process."

The Food and Drug agency regulates more than $1 trillion worth of products every year.

It ensures the safety and effectiveness of all drugs and biological products, including vaccines, medical devices, and animal drugs and feed. It also ensures the safety of all food except for meat, poultry and some egg products.

Obama appointed Hamburg as the new FDA lead during May. She has experience in public health, previously working in the second term of Bill Clinton's administration, and more recently at the not-for-profit Nuclear Threat Initiative in Washington.

In her new role she has made clear her aim to restore public confidence in the agency by putting science first and running an accountable operation.

On the announcement of the FDA taskforce she said: "I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making."

To support the efforts of the task force, a public meeting will be held to solicit recommendations on how the agency can make more available, useful and understandable information on its activities and decisions.

The responsibilities of the Task force include recommending ways the agency can better explain its operations compatible, but also maintain appropriate protection of confidential information.

It will also identify information the FDA should provide about agency operations, including enforcement actions and product approvals, and identify the barriers to providing useful information about FDA activities to the public.

It may also recommend legislative or regulatory changes if appropriate, to improve the FDA's ability to provide information to the public.

The initiative will be led by the FDA's new principal deputy commissioner Joshua Sharfstein, appointed last month to be Hamburg's assistant.

Sharfstein has in the past been identified as a critic of the pharmaceutical industry, and some say he may lead the agency to get tougher on medicines appraisals.

Last year Sharfstein successfully pushed the FDA to block drug makers from selling over-the-counter cough and cold medicines for use in small children, though he has also been an advocate of immunisation programmes.

He has also worked for Henry Waxman, the California Democrat who has been one of the industry's most consistent adversaries.

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