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REMARKS BY:

TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES

PLACE:

San Francisco

DATE:

June 7, 2004

Biotechnology Industry Organization

Thank you, Carl, for that kind introduction. (Carl Feldbaum, President of BIO).

It's great to see so many creative innovators in one room-innovators who use biotechnology to improve our health care, our agriculture, and our manufacturing.

Your industry has set amazing standards for getting ideas swiftly from lab bench to bedside-or to the grocery store. You translate innovative ideas into healthy people. My goal is to make sure my Department never adds any unneeded expenses, doubts, or delays to your progress, but always speeds you along.

Since I met with you last year, your support helped us pass the new Medicare law, which President Bush signed in December. Seniors are already getting help with the cost of their prescription drugs.

The federal government is finally giving seniors the lifesaving medicines your industry develops and manufactures.

So if you have parents or friends who are seniors, encourage them to call 1-800-MEDICARE or log on to medicare.gov and sign up for a drug discount card. It's completely voluntary, but they need to sign up to get the savings.

The Medicare law doesn't just help seniors. It also helps all Americans make their health care decisions more directly by allowing them to invest up to $4,500 a year, tax free, in a Health Savings Account. Depending on your tax bracket, you'll save up to 35 percent on medical spending from your account. I'd encourage all of you to help your families and your employees to set up these accounts and become more informed and more active consumers of health care.

Needless to say, 2004 is a great year to be a consumer of health care, and your industry is in the vanguard of 21st century medicine. Unfortunately, we still hold this 21st century technology together with 19th century paperwork.

We are solving this problem by encouraging the health care field to use interoperable electronic health care records, bar codes on medicines, and e-prescribing. These improvements will prevent medical errors. They will allow doctors to focus on the quality of their care, not the quantity of their paperwork. And they will save our system billions of dollars and thousands of lives.

Electronic health records will speed your drug and product trials by providing a bigger data set and faster feedback.

Bar codes on drug packages are helping hospitals deliver the right dose of the right medicine to the right patient at the right time.

And the next generation beyond bar codes is radio frequency identification, RFID's.

RFIDs are now cheap enough to be economical for tracking even small or inexpensive items. Hospitals use them to track inventory and personnel. And we believe RFID. technology can be employed to help in the fight against counterfeit drugs. How fast we can improve R.F.I.D. technology depends on the ingenuity of people like you.

Information technology can also massively improve care. Doctors can now monitor patients' vital signs and calibrate care daily through home testing devices as well as implanted wireless monitors. Doctors can also monitor Intensive care units from afar. The New England Journal of Medicine says this is easing the shortage of intensive care staff, lowering the cost, and improving the safety.

Your industry has set high standards for speed and quality in product development. Without sacrificing safety, we need to make sure that FDA works just as fast. When I took office, I was surprised at how cumbersome FDA reviews could be. I resolved to work with the FDA and the industry to make the whole process quicker, safer, and more efficient. And we've taken some important steps in the right direction.

Let me tell you about several of the improvements we have made.

First, thanks to BIO, PDUFA has been a great success. From 2002 to 2003, applications grew from 105 to 113, and priority applications grew from 15 to 24. FDA is exceeding its performance goals in reviewing these applications. On a parallel track, MDUFMA has launched improvements in our medical device reviews and approvals. Your suggestions have helped us implement both laws better.

We've also improved the review process for combination products. The Centers for Drugs and Devices at FDA are working together to get an incredible implant called the diabetes infusion pump on the market within a year. An even more dramatic breakthrough is currently being developed: an implantable pump with a biosensor that monitors blood glucose and continuously provides the right amount of insulin.

Traditionally, such sophisticated devices invite bureaucratic logjams and difficult regulatory questions. However, we have opened a new Office of Combination Products to ensure the most efficient review of these products. This new office is already improving our timeliness and responsiveness.

I resolved to speed up reviews and we have done just that. It currently takes up to 14 years to develop a drug. Under my leadership the FDA has reduced the average review time for priority drugs to only six months, and we are just getting started; I want to see it move even faster.

We want to work with you to continue to improve the whole process. We need to bring into the process new technology such as

  • pharmacogenomics,
  • advanced modeling of diseases and clinical trials "in silico" (on the computer),
  • and imaging technologies for use in drug development, such as P.E.T. and even newer technologies.

FDA is working with NCI to speed and facilitate the developments of all of these new technologies for cancer.

Here's an example. Cancer mutates cells. Conventional medicine responds by trial and error, trying different treatments until one fits.

With pharmacogenomics, we hope to be able to identify the mutation and pick the right treatment the first time.

We've already issued a draft FDA guidance on pharmacogenomics and we'll have a final guidance this summer.

As you use these technologies to develop new treatments, FDA needs the expertise to use them in our evaluation. So we are recruiting scientists in these areas and will be forming new scientific groups to help bring this technology into the agency. We regularly examine the organization of our clusters of review experts as we work to improve the speed, safety, and efficacy of drug approvals and development by 50%.

We are also encouraging you to submit your applications electronically. Submitting an application for a Biologics License Agreement (BLA) to the Center for Biologics Evaluation and Research (CBER) used to take days. Now, thanks to electronic submission, it takes minutes. We are working to achieve such capabilities across FDA.

We are also working to encourage more applications to FDA. In March, we announced a new initiative called the Critical Path, which will help to facilitate faster innovation by partnering with industry and academic institutions to develop the science and technology used in the drug development process. One expert says this could reduce the costs of clinical trials by 50%.

By clarifying and improving the critical path - which leads from lab bench to bedside - we can lower the risk of investing in innovation, increase opportunities for competition, and lower prices for consumers.

We know we need to develop broader cross-center multidisciplinary teams to review novel products, such as stents, or advanced techniques, such as tissue engineering and nanotechnology.

Another major reform is Good Manufacturing Processes. Instead of focusing on penalties after the fact, we decided to work with industry and encourage you to continue to improve your manufacturing process. We'll announce additional progress at the end of the summer. Red tape should not impede progress.

In order to reduce the risks of adverse health effects caused by food, we plan to make critical path and GMP reforms on the food side of FDA as well-from farm to fork.

I have also asked Les Crawford to lead my new Task Force on Medical Innovation Technology to recommend further improvements.

This task force will look at how we can partner with industry and academic institutions to find barriers to innovation and reduce them. I have issued questions in the federal register and I hope to get comments from everyone in this room.

Improving FDA is helping people around the world. Last month in Geneva, for example, I announced faster FDA approvals for new combination drugs to fight AIDS in Africa. Companies will now have new incentives to develop easy-to-use antiretroviral drugs at lower prices. We will approve applications for new combinations in six weeks. We will fight HIV and AIDS for millions of people in the hardest hit nations with high-quality products.

Your industry and the drug and device industries are developing, licensing, testing, and marketing medicines all across the world. And manufacturers and consumers deserve access to each other, whether they are around the corner or across the ocean.

We are working to ensure this free access. My Department has worked closely with the governments of Switzerland, Singapore, Canada, the European Union, and Australia to reach agreements on sharing confidential information, such as draft reviews and early guidance documents. These agreements will make it easier to develop and approve drugs and biologics, by assuring that international standards are based on science and promote good health, not local markets.

This administration has also promoted good health by protecting Americans against infectious diseases and bioterrorism. In my Department alone, we are spending more than 30 times as much on bioterrorism research as we did in 2001. We've increased food import inspections fivefold from 12,000 in 2001 to 60,000 in 2004.

We have more than enough of the smallpox vaccine to vaccinate every man, woman, and child in America, if necessary. And we're working toward an improved anthrax vaccine. We expect it to be available next summer in case we need it.

I appreciate your industry's wonderful cooperation on improving vaccine technologies. We still need better protection against one of the most deadly infectious disease threats: Influenza. Make no mistake about it. The flu is more than an annual nuisance: it is a grave threat that we must conquer. While the current vaccine has served us well, we need a better one.

We need a vaccine that is effective against a broad spectrum of antigens. We need a vaccine that is more effective among the elderly and the vulnerable. And we need a vaccine produced by 21st century technology that is more amenable to rapid expansion. The use of eggs for influenza vaccines dates back to the early days of the last century. Don't you think we should be using new technology to come up with a better process that provides lifelong immunity? This would greatly simplify our vaccination program and prepare us for the one threat we know will arrive: an influenza pandemic.

The biotech industry can and must help develop this better flu vaccine.

The avian influenza virus that spread through Asia earlier this year resists all but one class of antiviral drugs. If this virus evolves, or if a new virus emerges, we could find ourselves with no drug that can treat this infection. Therefore, we also need to work together to develop new antiviral drugs against influenza.

We are also responding to emerging diseases, including West Nile, SARS, and Avian flu. We've identified problems early and given you critical tools, such as strains, samples, and help in navigating development pathways. We moved from recognizing the West Nile threat to nationwide blood screening in only 8 months.

Another way to prepare for emerging and re-emerging diseases that threaten us in the twenty-first century is Bioshield. Both Houses of Congress have approved the Project Bioshield bill, and I hope they will send it to President Bush soon. Bioshield funding will allow us to acquire up to 75 million doses of the new anthrax vaccine as well as state-of-the art counter-measures against smallpox, plague, tularemia, botulinum toxin, and Ebola.

I would like to close by challenging this industry to solve several problems.

You can help us develop sensitive and specific diagnostic tools for novel influenza strains and SARS.

You can help us improve food safety. You can do this by developing rapid detection methods as well as biosensors for in-line detection of food-borne pathogens or select agents. And you can develop technology to allow rapid traceback.

You can help us prevent chronic disease. As you've heard, obesity is on the verge of overtaking tobacco as the leading cause of preventable death. But losing weight is not easy. Maybe there's a biotech solution.

Most of all, you can help us to further improve and streamline product development and review. I welcome your suggestions for getting safe and effective drugs, biologics, devices, combination products, and vaccines to market faster.

You keep pushing forward the frontiers of science, and we'll keep updating our organization to reflect those new frontiers.

The solutions to these and so many other great challenges lie in the capable, innovative hands of the biotech industry, and that gives me great confidence that they will be solved. I will continue to work with you as you make new advances to improve the health, safety, nutrition, and quality of life for millions of people around the world.

Thank you.

Last Revised: June 14, 2004

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