THIS ISSUE AVAILABLE ONLINE WITH EXPANDED INFORMATION AND PHOTOS AT:
http://www.hhs.gov/news/newsletter/weekly
IN THIS ISSUE:
1) HHS Proposes Rapid Process for Review of Fixed Dose Combination and Co-Packaged Products
2) United States Signs Tobacco Control Treaty
3) CDC Announces New Goals and Organizational Design
4) PREVENTION: HIV Vaccine Awareness Day, May 18, 2004
5) Science in the News: Arthritis Prevalence in the United States
6) Medicare Minute: CMS Adds Resources to Respond to Record Numbers of Callers and New Steps Make It Easier for Seniors Interested in Medicare Discount Drug Card
7) Secretary Thompson's Public Schedule
HHS Proposes Rapid Process for Review of Fixed Dose Combination and Co-Packaged Products
HHS Secretary Tommy G. Thompson and U.S. Global AIDS Coordinator Randall L. Tobias announced Sunday an expedited review process to ensure that the United States is providing safe, effective drugs to developing countries under the President's $15 billion Emergency Plan for AIDS Relief. Under the new guidance to be proposed next week by HHS' Food and Drug Administration (FDA), the United States will be able to provide life-saving drugs at lower prices to millions of people in Africa and the Caribbean.
Secretary Thompson and Ambassador Tobias said drug patent issues that apply in developed nations should not impede purchase of these drugs for developing countries. The FDA guidance will apply to new products that combine already-approved individual HIV/AIDS therapies into a single dosage, known as fixed dose combinations (FDC), as well as to new co-packaging of existing therapies. Drugs that are approved by FDA under the process described in the guidance will meet all FDA standards for drug safety, efficacy, and quality, said Acting FDA Commissioner Lester M. Crawford.
The expedited review process, combined with the work of local drug regulatory authorities in the affected countries, will provide a mechanism to ensure that safety, efficacy, and quality standards are met and maintained by companies providing drugs for the President's Emergency Plan for AIDS Relief. President Bush has pledged $15 billion for this initiative to address the global HIV/AIDS pandemic in developing nations, through prevention, care and treatment programs that include the purchase of HIV/AIDS drugs.
"We are clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries," Secretary Thompson said. "We are committed to ensuring that President Bush’s Emergency Plan for AIDS Relief is providing medical care as effectively and efficiently as possible. Fixed dose combination products and co-packaged products are an important tool in improving the quality of health care in developing nations."
"The President has made clear that his goal is to put effective treatment into the hands of those who need it in the hardest-hit developing nations, and to provide these life-saving services as widely as possible," said Ambassador Tobias. "At the same time, we must apply real discipline to ensure that the products we provide in poor nations are safe and effective. The new expedited process provides us with a solid foundation for purchasing drugs that work. With FDA review, we will have a gold-standard assurance that a combination product will be safe and effective."
The guidance will outline four scenarios for review of different FDC and co-packaged products. Some of the scenarios could permit approval in as little as two to six weeks after submission of a high quality application. For companies making products where another firm owns the U.S. patent rights, FDA could issue a tentative approval when it finds the product meets the agency's normal safety and efficacy standards.
Control of HIV/AIDS generally requires use of several different drugs simultaneously. Combination products would bring together different HIV/AIDS drugs in a single medication or co-package, thereby facilitating patients' compliance with often complicated drug regimens.
Secretary Thompson urged manufacturers of brand-name and generic drugs alike to work with FDA and submit applications. "HHS has opened the door to rapid review of new combination products," he said. "This means companies will have new incentives to develop easy-to-use products at lower prices. It also means we will provide a sound scientific basis to Ambassador Tobias for the very substantial purchases that the President's Emergency Plan will be making on behalf of millions of people in the hardest hit nations. This is essential - to skirt the safety and efficacy issues would be wrong and dangerous."
The guidance will include a list of currently approved drugs for which FDA believes there are existing clinical safety and efficacy data supporting combination use. There are more than 20 unique anti-HIV medications approved in the United States.
The draft guidance will be open for a 60-day comment, but it is effective and active immediately.
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United States Signs Tobacco Control Treaty
On behalf of the United States, HHS Secretary Tommy G. Thompson signed the Framework Convention on Tobacco Control (FCTC) on Monday, May10 at the United Nations in New York. The FCTC is the first-ever global public health treaty negotiated under the auspices of the World Health Organization (WHO).
The treaty serves as an important basis for advancing public health worldwide. It encourages other nations to establish standards similar to the ones set for tobacco prevention and control domestically in the United States. For example, the treaty contains a strong U.S.-drafted provision against tobacco smuggling, which could help prevent illicit trade in tobacco.
"The United States has long been a world leader in anti-smoking efforts," Secretary Thompson said. "We have committed more resources than any other country to the research, development and evaluation of smoking control and cessation programs, both at home and abroad. President Bush and I look forward to working with the WHO and other member nations to implement this agreement."
Secretary Thompson noted that the United States is making strides in reducing death and disease caused by tobacco as well as in diminishing use, especially among children. Youth smoking rates have dropped significantly in this country among minors -- from 18.9 percent in the mid-1990s to 13 percent in 2002. However, tobacco-related illness remains the leading preventable cause of death among adult Americans.
The United States, with HHS as the lead agency, participated actively throughout the drafting process and negotiations to help achieve a strong and effective instrument for global tobacco control. The World Health Assembly adopted the FCTC in May 2003. The United States becomes the 108th nation to sign this treaty.
The FCTC is intended to provide for basic tobacco control measures to be implemented by all parties through domestic law. The objective of the FCTC is to protect "present and future generations from devastating health, social, environmental and economic consequences" of tobacco use and to reduce the prevalence of tobacco use and exposure to tobacco smoke.
The treaty is open for signature until June 29. The treaty will take effect after 40 nations have ratified it; 12 nations have ratified the FCTC so far. The next step for the treaty in the United States is submission to the Senate, following completion of further interagency review of the treaty.
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CDC Announces New Goals and Organizational Design
Centers for Disease Control and Prevention (CDC) Director Dr. Julie Gerberding announced Thursday new goals and integrated operations that will allow the federal public health agency to have greater impact on the health of people around the world. Thursday's announcement evolved from an ongoing strategic development process called the Futures Initiative which began a year ago at CDC and has included hundreds of employees, other agencies, organizations, and the public.
Dr. Gerberding announced that CDC will align its priorities and
investments under two overarching health protection goals: 1) Preparedness:
All people in all communities will be protected from infectious,
environmental, and terrorists threats. 2) Health Promotion and Prevention
of Disease, Injury and Disability: All people will achieve their
optimal lifespan with the best possible quality of health in every
stage of life. In addition, the agency is developing more targeted
goals to assure an improved impact on health at every stage of life
including infants and toddlers, children, adolescents, adults, and
older adults.
The integrated organization coordinates the agency's existing operational
units into 4 coordinating centers to help the agency leverage its
resources to be more nimble in responding to public health threats
and emerging issues as well as chronic health conditions.
"For more than half a century this extraordinary agency with the greatest workforce in the world has accomplished so much for the health of people here and around the world," said CDC Director Dr. Julie Gerberding. "However, today's world characterized by tremendous globalization, connectivity, and speed poses entirely new challenges. The steps we are taking through this initiative will better position us to meet these challenges head on. Our aim is to help ensure that all people are protected in safe and healthy communities so they can achieve their full life expectancy."
Dr. Gerberding and executive leaders throughout CDC will be moving forward to implement these changes by October 1, 2004, the start of the next fiscal year.
For a complete list of the new coordinating centers and their directors,
please go to: http://www.cdc.gov/od/oc/media/pressrel/r040513.htm
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PREVENTION
HIV Vaccine Awareness Day, May 18, 2004
May 18th marks the seventh annual HIV Vaccine Awareness Day. It is a day to educate Americans about the urgent need for preventive HIV vaccines and to thank participants in HIV vaccine trials for their selfless dedication to ending the HIV pandemic. This year's theme is "Real People, Real Progress," embodying the thousands of volunteers and researchers involved in the search for effective preventive HIV vaccines.
HIV/AIDS continues to devastate communities in the United States and around the world Approximately 40 million people worldwide are estimated to be living with HIV/AIDS. In the United States, nearly one million people are living with HIV/AIDS, and more than 40,000 people become infected with HIV each year. HIV is the number one killer of African-American men between the ages of 25 and 44, and the third leading cause of death among Latinos between the ages of 35 and 44. It also is the third leading cause of death among all women between the ages of 25 and 44.
While people of color are overrepresented among U.S. HIV/AIDS cases, they are underrepresented in U.S. preventive HIV vaccine trials. Many reasons account for this, but one fact remains resolutely and absolutely clear: when we find a vaccine we will need to show that it works for everyone regardless of their race, ethnicity or gender. To accomplish this, all communities must be involved in the search for a vaccine. Future trials will require more individuals to volunteer than ever before, and those individuals must be representative of the most affected communities.
NIAID's Vaccine Research Center, the NIAID-supported HIV Vaccine Trials Network and our colleagues in the public and private sectors are leading the effort to test HIV vaccines. Many community-based and national organizations are working with NIAID and taking a strong leadership role in educating their constituents about ongoing research by providing accurate, timely and culturally relevant information.
For the second year in a row, the day will be commemorated with a twist on a familiar symbol of AIDS awareness, the red ribbon. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, at NIH asks you to wear your AIDS ribbon upside-down to symbolize a "V" for vaccines and the vision of a world without AIDS. Ultimately, this vision is our best hope for all.
For information about HIV Vaccine Awareness Day, including a list organizations
commemorating HVAD, visit www.aidsinfo.nih.gov,
or call 1-800-HIV-0440.
To learn about Vaccine Awareness Day activities around the country, visit
www.niaid.nih.gov/newsroom/mayday/.
For more information on HIV vaccine research, please visit: http://www.niaid.nih.gov.
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Science in the News: Arthritis Prevalence in the United States
The CDC released Thursday new facts about the prevalence of Arthritis in the United States.
Arthritis is the leading cause of physical disability in the United States.
Arthritis comprises over 100 different disease and conditions. The most common are osteoarthritis, rheumatoid arthritis, fibromyalgia, and gout.
Arthritis is estimated to cost $51 billion in medical costs and $86 billion in total costs.
Arthritis limits everyday activities for 8 million Americans.
According to CDC's Behavioral Risk Factor Surveillance System, which provides the main source of state arthritis data, 49 million American adults reported doctor-diagnosed arthritis and another 21 million reported chronic joint symptoms (CJS) in 2001.
The number of people age 65 and older who have arthritis or chronic joint symptoms is projected to nearly double from 21.4 million in 2001 to 41.4 million in 2030 as the population ages.
Older adults 65 years of age or older have the highest risk of arthritis (58.8 percent), but two-thirds of all people with arthritis are younger than age 65. Arthritis was noticeably higher for women (37.3 percent) than for men (28.4 percent).
Research shows that physical activity decreases joint pain, improves function and delays disability. In addition, maintaining a healthy weight and avoiding joint injuries reduces the risk of developing arthritis and decreases disease progression.
CDC currently funds 36 states to implement programs to improve the quality of life of people that have arthritis. Of the 36 funded states, 35 will implement "The Arthritis Pain Reliever" health communications campaign. This campaign promotes physical activity to relieve arthritis pain among people aged 45-64.
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Medicare Minute
CMS Adds Resources to Respond to Record Numbers of Callers and New Steps Make It Easier for Seniors Interested in Medicare Discount Drug Card
The Centers for Medicare & Medicaid Services Wednesday announced additional steps to improve service for Medicare beneficiaries deciding whether a discount card is right for them. This includes adding 400 more customer service representatives to answer calls on the 1-800-MEDICARE hotline and enhancing the "Price Compare" database at www.medicare.gov.
Last week CMS received more than 10 times the regular call volume, with 1.6 million calls to 1-800-MEDICARE and more than 7 million internet visits. CMS is now increasing the number of customer service representatives at the Medicare call centers, bringing the total to more than 1,800. CMS had previously tripled the number of operators from nearly 400 in August to 1,400 last week. CMS is getting the additional help from trained customer service operators from some Medicare contractors; the private companies that process and pay Medicare Part B claims.
Enhancements are also being implemented in Medicare's Price Compare services based on feedback from beneficiaries, customer service operators, and advocates. For example, www.medicare.gov now has a new, easily visible link making the Price Compare database easier to find, and the "drug dictionary" of drugs included on Price Compare is being expanded.
Website users and callers to 1-800-MEDICARE can now get an easy-to-use list of information to have available to help them find the best cards for their needs as quickly as possible. The list includes pill bottles or a list of drugs and dosages, favorite pharmacies, whether the beneficiary has a preference for low- or no-fee cards, and income information, if the beneficiary is interested in the $600 credit and other low-income assistance programs.
When calling Medicare, beneficiaries should be prepared to answer a few important questions about their prescription drug needs. CMS call centers use this information to sort through all of the medicines, drug discount cards, and pharmacies to give beneficiaries the specific, individual facts they need to decide about the drug card program. This includes:
The best times to call 1-800-MEDICARE is later in the week - Thursday
through Sunday and between 6 p.m. and 6 a.m. Eastern time.
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Secretary Thompson's Public Schedule:
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Last updated: May 17, 2004
United States Department of Health and Human Services
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