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Working towards increased FDA transparency

A few weeks ago, the Food and Drug Administration announced a new internal task force that would examine how the agency can become more transparent. The group would seek suggestions from employees, stakeholders and the public in an effort to reach the best conclusions about how the FDA could become more accessible. (For an overview of what the FDA does and does not regulate, see this Time article.)

Sure enough, the FDA has lived up to its promise. Today, Public Citizen’s own Dr. Peter Lurie, deputy director of our Health Research Group, is representing American consumers with testimony before the task force. While current FDA procedures favor secrecy so that drug companies can keep competitors in the dark about products being developed, Dr. Lurie will make three recommendations before the task force that will allow the FDA to become more open to the public.

First, Dr. Lurie will recommend that pre-approval documents should be made available to the public. This will prevent scientists from researching products similar to those that, unbeknownst to them, prior research has deemed unsafe, squandering time and money going down roads already proved to be dead ends. In addition, making this information public can save clinical trial participants from being put at needless risk by enrolling them in research likely to prove fruitless.

The second recommendation is to expedite and make more consistent the FDA’s procedures for handling requests made under the Freedom of Information Act. The data in the FDA’s 1998-2008 Freedom of Information Annual Reports reveal a consistent decline in the number of FOIA requests received for 1998-2003, followed by a leveling off in requests for 2003-2006. However, in that same period, the backlog of requests grew from about 13,000 to almost 20,000, as requests processed did not keep up with even the declining number of requests.

Finally, Dr. Lurie will recommend that FDA-approved medication guides should be provided to patients with each prescription. In fact, in February, the FDA’s Risk Communication and Drug Safety and Risk Management Advisory Committees made the same recommendation, concluding that the unregulated patient information currently provided in pharmacies is seriously deficient in the information provided about safety and other important issues. It unanimously endorsed a mandatory, standardized, FDA-approved format for communicating drug risks and benefits to patients with each prescription filled. Dr. Lurie will urge the FDA to move as quickly as possible to implement this recommendation.

We’re glad to be able to share our experiences with the FDA in an effort to improve the agency. Once again, Public Citizen is working on behalf of consumers like you to make sure that the medicines we take are safe and the information we need about them is easily accessible.