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In 2006, the Food and Drug Administration (FDA) commemorated its 100th anniversary as America's premier public health agency by safeguarding the safety and high quality of more than a trillion-dollars worth of products that are critical for the survival and well-being of all Americans -- products that include 80 percent of the United States food supply and all human health care products, electronic products that emit radiation, animal products, and cosmetics.
To accomplish this constantly growing mission, the three FDA line organizations that regulate health care products -- Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) streamlined and improved their processes while continuing to ensure the safety and effectiveness of thousands of new drugs, biological medications and medical devices .
"FDA's centennial year was most fittingly celebrated by numerous contributions to our mission to protect and promote the health of the public," said Dr. Andrew C. von Eschenbach Commissioner of Food and Drugs. "From new life-saving drugs and vaccines to innovative devices, the lives of millions of people have been improved by the dedicated efforts of FDA employees. It a strong foundation upon which to build in the 21st century."
FDA's 2006 accomplishments are summarized in two additional documents:
Below are the highlights of the missions and 2006 core activities of FDA's CDER. CBER and CDRH:
CDER reviews research supporting new applications for drug and biological treatments and ensures that safe and effective prescription and over-the-counter medicines are available to Americans.
In 2006, CDER approved a total of 101 new products, including 97 new drug applications (NDAs) and 4 biologic license applications (BLAs) for brand-name therapeutic products. Twenty-two (18 NDAs and 4 BLAs) of these products were new molecular entities (NMEs), medications whose active ingredients are new on the United States market. Ten of the NMEs were priority products approved in the median time of 6 months, and 12 were standard NMEs approved in the median time of 13.7 months (compared to 23 months in 2005). Of the101 approved applications, 21 -- including the 10 NMEs -- represented significant benefits over existing products, and were designated for priority review. They included 5 antiretroviral drugs tentatively approved for use under the President's Emergency Plan for AIDS Relief to provide HIV/AIDS treatment in 15 of the world's most severely affected countries.
CDER's most significant approvals include Januvia (sitagliptin phosphate) for blood sugar control in patients with type 2 diabetes; Sutent (sunitinib malate) for the treatment of resistant tumors of the gastrointestinal tract and advanced kidney cancer; Sprycel (dastinib), a therapy for several types of leukemia; Chantix (varenicline), a novel product to aid smoking cessation; Myozyme (alglucosidase alfa) for the treatment of Pompe disease; Lucentis (ranibizumab) to help prevent vision loss due to wet age-related macular degeneration; Renexa (ranolazine), a novel drug for angina; and Elaprase (idursulfase) to treat Hunter Syndrome, a rare disease that leads to abnormal growth.
In addition, CDER approved or tentatively approved 535 -- the highest total ever --abbreviated new applications (ANDAs) for generic versions of brand name medications. These products, which are lower-priced but equal in safety, effectiveness and quality to their brand name counterparts (included in parentheses), include the following tablets: simvastatin (Zocor) and pravastatin (Pravachol) to treat elevated cholesterol levels; sertraline (Zoloft) for depression; and meloxicam (Mobic) for pain relief. Other significant generic approvals included ondansetron tablets and injection (Zofran) to treat nausea, and fluticasone nasal spray (Flonase) for seasonal allergies.
CBER is responsible for overseeing the safety and effectiveness of biological products including blood and blood components, plasma derivatives, in vitro diagnostic tests, vaccines, allergenics and cell, tissue, and gene therapeutics.
In 2006, CBER approved 10 new biological license applications (BLAs) that are expected to significantly enhance the public health. Three of these products received priority reviews in the median time of 6.4 months; the remaining 7 new BLAs received standard reviews in the median time of 13 months. CBER approved also 7 supplemental applications for additional product indications , routes of administration, dosage formulation or product improvements. These applications were reviewed in the median time of 9.9 months.
CBER's major approvals included the following vaccines: Gardasil, the first biological product to prevent cervical cancer; Zostavax, to reduce the risk of shingles (herpes zoster) in people over the age of 60; RotaTeq, for the prevention of rotavirus gastroenteritis infection in infants and children; and FluLaval, to help prevent influenza. Other medically significant new approvals included Vivaglobin, for the prevention of serious infections in patients with Primary Immune Deficiency Disease; and ORTHO T. cruzi Elisa Test System to screen blood, tissue and organ donors for antibodies to the parasite that causes Chagas disease.
CDRH is charged with ensuring the safety and effectiveness of medical devices and the safety of radiological products.
Last year, the Center approved 39 premarket approval (PMA) applications for original devices, and cleared for marketing 3217 new devices based on already known technologies. The approved PMAs included such novel devices as AbioCor, a totally implantable replacement heart; Olympic Cool-cap, a system for preventing or reducing brain damage in infants; and Luma, a new imaging system that can help detect the precursor of cervical cancer. CDRH also expanded the availability of LeadCare II, a simple and fast blood test for screening children and adults for harmful levels of lead.