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Lester M. Crawford, D.V.M., Ph.D. - FDA All-Hands Briefing

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
FDA All-Hands Briefing with New HHS Secretary Mike Leavitt

Remarks by
Lester M. Crawford, D.V.M., Ph.D.

Acting Commissioner of the FDA

Feb. 15, 2005
There has been considerable publicity of late regarding high-profile products about which safety questions have been raised. It is important that these concerns do not distort the fact that drugs are safer today than they have ever been before and that millions of Americans each day benefit from drugs that keep them alive and enhance their quality of life.

As you know, before a prescription drug is marketed in the United States, the Food and Drug Administration (FDA) oversees a rigorous evaluation process to determine that the drug is safe and effective for the uses listed on the label. Yet, even very large and sophisticated clinical trials before a drug is approved can not predict all the effects in different individuals that will occur in medical practice.

The challenge for the 21 st century at FDA is that traditional scientific methods for evaluating health products both before and after a product is approved moves methodically and deliberately and generalities about medical care often are hollow when applied to individual patients with individual needs. While drug safety is studied more thoroughly than ever before, public expectations for more information have created new opportunities to empower consumers to work with their health care providers to personalize today’s innovative treatments.

As part of your new vision for a 21 st Century FDA, today we are proposing fundamental and immediate steps to improve the drug safety system while protecting patient privacy and embracing the promise of the new electronic healthcare era. These steps will improve FDA’s surveillance of drug safety and increase the independence and transparency of our decision-making processes

As Secretary Leavitt noted, a pillar of all FDA information collection, evaluation, and communication proposals in an age of increasing electronic health information must be a strict adherence to maintaining patient privacy. FDA is committed to maintaining patient privacy while we undertake steps to fully capitalize on new data sources to monitor and asses the outcomes of drug therapy.

Specifically, FDA is announcing two proposals for immediate steps to improve the way the Food and Drug Administration (FDA) manages and communicates drug safety information. These proposals focus on making FDA’s review and decision-making processes more independent and transparent.

First, FDA will take a bold first step to enhance the independence of internal deliberations and decisions regarding risk and benefit analyses and evaluations and consumer safety by creating an independent Drug Safety Oversight Board (DSB). The DSB will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER). The board will comprise members from the FDA and medical experts from other HHS agencies and government departments (e.g., Department of Veterans Affairs) who will be appointed by the FDA Commissioner. The board also will consult with other medical experts and representatives of patient and consumer groups.

Second, the Agency will bring the power of information about drug risks and benefits, and how such information is evaluated by agency scientists, directly to the consumer. Specifically, FDA will increase the transparency of the agency’s decision-making process by expanding existing communication channels and establishing new ones to provide targeted drug safety information to the public. These channels will be used to help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased transparency will enable patients and their healthcare providers to make better-informed decisions about individual treatment options, which will lead to better health outcomes. The Agency is proposing a new Drug Watch Web page for emerging data and risk information and increased development and availability of consumer–friendly information sheets written especially for healthcare professionals and patients.

The establishment of new and expanded use of existing communication channels will significantly enhance public knowledge and understanding of safety issues. In some cases, information provided through these new channels will include discussion of emerging or potential safety problems even before the FDA has reached conclusions that would prompt a regulatory action. The targeted information and related FDA perspective will be updated as information evolves to provide greater transparency and access to current data.

As FDA develops these communications formats, the Agency will be soliciting public input on how FDA should manage potential concerns associated with disseminating emerging information prior to regulatory action. The Agency will issue draft guidance on procedures and criteria for identifying drugs and information for the Drug Watch Web page and actively seek feedback from healthcare professionals and patients on how best to make this information available to them. Over the next weeks we will be scheduling additional briefings to engage the public in constructive dialogue regarding these and other next steps.

As we work together, both inside and outside the FDA to implement the new Vision for 21 st Century to protect and promote the public health, I want to emphasize the team oriented approach to science here at FDA. Our decisions benefit from the input of many different scientific and legal perspectives. Within any such setting there will be people with differing views; however, we recognize that it is essential to maintain an environment in which any individual can freely express a scientific point of view. We have established new procedures and policies internally to make sure that all views will be heard.

In 2006 the FDA will celebrate its Centennial and I am confident that, as we go forward to implement the vision and steps I have outlined today, the present FDA remains fully committed to advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Thank you.