FDA Sued Over Redacting its Experts’ Job History

Friday, April 29, 2016

Source: FierceBiotech

Public Citizen has issued a lawsuit against the FDA in an attempt to force it to come clean on the employment history of the regulator’s advisory committee members who help to assess new drug approvals.

The Washington, D.C. consumer rights group Public Citizen has filed the Freedom of Information Act (FOIA) after it discovered that the agency redacted copies of the CVs from its expert advisors.

The FDA has around 50 advisory committees composed of outside experts who advise the agency on issues such as whether the FDA should approve new medical products or change a product’s labeling.

The FDA frequently (although they are not obliged to) follows the recommendations of its advisory committees, but Public Citizen has taken exception to the fact that the FDA redacts information from most of the advisory committee members’ CVs posted on its website.

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