The FDA says it will forge ahead with a plan to convey preliminary drug safety concerns to the public, despite criticism that it could lead to confusion about prescription drugs.
The plan, part of the agency's broad initiative on drug safety, was rehashed in the just-released "CDER 2004 Report to the Nation," from the Center for Drug Evaluation and Research. The initiative centers on giving patients and healthcare professionals quick and easy access to timely information on medicines. The key word there is timely.
"Emerging or potential safety problems can be discussed even before we have reached conclusions that would prompt a regulatory action," the report states.
The FDA's new, independent Drug Safety Oversight Board will be charged with deciding what safety updates are placed on a proposed Drug Watch Web page.
That plan has irked some. In written comments to the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA) said releasing preliminary information online could lead to "irrational fears" and stoke confusion among the public.
Expansion of communication channels and quicker dissemination of information are not new examples of FDA's "culture of openness." In February then acting commissioner Lester Crawford and HHS chief Michael Leavitt released separate statements on a plan for the Drug Watch Web page as a way to make FDA decision-making more transparent. Also at that time, they created the Drug Safety Oversight Board, giving it discretion over the site.
But the CDER performance report fleshes out the plan further: The board "will place 'emerging' drug safety information on [the Drug Watch] site, such as possible serious side effects of particular drugs, before we have fully determined that the drug was responsible," the report explains.
Such information also could include other safety risks that have the potential to alter the benefit and risk analysis of a drug or affect patient selection. One-page information sheets on drugs, available online to physicians and consumers, are other components of the agency's enhanced communication plan.
"Drug safety has been and will continue to be a top priority for us," the report states, adding that CDER staff spend about half their time addressing safety issues.