U.S. Pharmacopeia Convention

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Speech before

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs

March 11, 2005

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.

INTRODUCTION

Good morning and thank you for your kind introduction.
I want to thank Dr. Brater for inviting me.
It is truly an honor to be here to address your Convention on behalf of the United States Food and Drug Administration.
I want to first congratulate you on the 185 th anniversary of the founding of your organization. USP’s steadfast dedication to protecting and promoting public health over the last 185 years has led to remarkable achievements in the strength, quality and purity of medicine.

HISTORY OF PARTNERSHIP

The history of partnership between FDA and USP goes back a long way. It began with FDA’s founding father, Dr. Harvey Wiley, serving as President of the USP from 1910-1920.
Over the years, our experts have worked with your committees in setting gold standards for drug safety, developing and reviewing compendial tests and assay methods. The list of joint projects goes on and on.
In short, the FDA shares with USP the tradition, the effort and the responsibility for upholding the highest standards possible for our public health. In fact, the FDA literally shares the same roads as USP – Twinbrook Parkway and Fishers Lane.
To this end, I want to express my strong support for the goals outlined by USP in your resolutions for this convention. These are lofty expectations set to challenge each and every one of you. But I am confident USP can continue to deliver its high quality of work for the American public.

FDA OVERVIEW

I want to take this opportunity to quickly update you on some of the FDA’s past achievements and upcoming initiatives.
The FDA made great headway since your last convention in 2000. We have created efficiencies, standardized processes, enhanced our infrastructure, and improved our plan to create a stronger, more unified and more effective Agency.
There are four specific initiatives I want to highlight that may be of interest to you.
1. Current Good Manufacturing Practices (cGMPs)
  
  Good manufacturing practices are not only vital to business success; they are also essential to FDA and they are essential to the public health.
  
  The FDA’s overhaul of the pharmaceutical cGMPs encourages manufacturers to modernize their methods, equipment and facilities that will help eliminate both production inefficiencies and undue risks for consumers.
  
  The initiative also implements tougher inspections rules to make them more targeted and effective.
2. Critical Path
  
  The essence of the Critical Path Initiative is that the process of medical product development has become costlier, lengthier and more uncertain than ever before. There's a growing chasm between bench and bedside, and it is threatening the very promise of biomedical innovation as the research and development community begins to focus on a group of incurable diseases such as Alzheimer's, multiple sclerosis, lupus and cystic fibrosis.
  
  In response to this serious problem, FDA has developed a versatile applied science toolkit containing powerful scientific and technical methods such as animal and computer based predictive models, biomarkers for safety and effectiveness and new clinical evaluation techniques. The goal is to help predict eventual product failures early during clinical trials and to reduce developmental uncertainties in 3 critical product areas: product safety, medical utility and manufacturing potential.
  
  Critical Path will, we are convinced, improve predictability and efficiency and get much needed treatments to patients faster.
3. Generics Rule
  
  The Agency promulgated a rule to enhance the approval process for generic drugs so we can get more affordable medicine to American patients.
  
  We have already seen signs of this measure’s success. Last year the FDA approved a record number of generic drugs. The total approval of 474 generic drugs is 110 more than in 2003 and 90 more than in 2002.
4. Drug Safety Oversight Board (DSB)
  
  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 them.
  
  But in order to improve on current process, FDA has taken a bold first step to enhancing the independence of internal deliberations decisions regarding risk and benefit analyses and evaluations by creating an independent Drug Safety Oversight Board that will oversee the management of important drug safety issues within our Center for Drug Evaluation and Research (CDER)
We are extremely proud of these accomplishments and we will continue to improve on these initiatives. However, our successes are continually challenged by emerging health threats, changes in technology and variant global market forces.
FDA’s responsibilities are growing in scope and complexity, and we are responding by focusing on new and better ways to perform our core mission.

Our vision for a 21 st Century FDA includes

innovation in product development
greater access for pre-market approvals
global standards and technologies to maximize post-market product safety, quality and security;
better use of electronic health records, state-of-the-art surveillance systems, and risk communications to promote the safe use of marketed products.
transformation in technology to create a paperless, information-driven, and collaborative environment.

These are some of the highlights of a very productive and forward agenda. FDA is committed to fulfilling our goals.

CONCLUSION

However, as is frequently the case, the urgency of these programs is not matched by our resources. And as it has happened so many times before, we will have to rely on our stakeholders and allies for help.
I am echoing the appeal of my predecessors in requesting the help of your organization to achieve our priorities. One arena where your members and volunteers can be of particular help is sending the FDA more data on drug-associated adverse events.
These data, which many of you receive first-hand from patients, provide vital drug safety information for our programs and is essential in restoring the confidence of Americans about the quality of their medication and health care system.
Enhanced partnerships like the information exchange between FDA’s MedWatch program and USP’s Practitioner Reporting Network and Medication Error Program will go a long way in meeting both our organizations’ goals.
Again, my congratulations on the success of this convention and the 185 years of success for this organization.
As the FDA prepares to celebrate its own centennial in 2006, we look forward to continuing our two organizations’ collaboration to further advance America’s public health.

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