U.S.
Food and Drug Administration
FDA Consumer magazine
November-December 2002
Table of Contents
The FDA has announced its decision to consolidate responsibility for reviewing most new pharmaceutical products into the FDA's Center for Drug Evaluation and Research (CDER). Previously, this review had been performed in part by the FDA's Center for Biologics Evaluation and Research (CBER) and in part by CDER.
The change in review responsibilities will allow CBER to concentrate its scientific expertise in the crucial areas of vaccines and blood safety--both top priority items critical to national defense and public health. In addition, CBER will be able to concentrate its expertise on such cutting-edge biological scientific areas as gene therapy, tissue transplantation, and new cellular therapies.
Companies should continue to work with CBER and CDER as they have in the past until the FDA issues further guidance. Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., expects to have an action plan and timeline for the consolidation in January.
The Centers for Disease Control and Prevention (CDC) awarded more than $6.3 million in September to 25 states, three cities, and the District of Columbia to help combat West Nile virus. This brings the total CDC funding to states and cities for West Nile virus so far this year to approximately $35 million.
In addition to funding, the federal government continues to provide technical and scientific support to states and communities in need of assistance. The CDC has deployed epidemiologists and clinicians to Louisiana, Mississippi, Arkansas, and Chicago. "We are working closely with state and local health departments to bolster their efforts to protect residents from West Nile virus," says Health and Human Services Secretary Tommy G. Thompson.
Between January and early October 2002, more than 2800 human cases of West Nile virus had been reported in 35 states and the District of Columbia. Nationwide, at least 150 human deaths attributed to West Nile virus had been recorded during that period. The virus is spread by the bite of an infected mosquito, and can infect people, horses, many types of birds, and some other animals.
The CDC recommends that people take the following steps to help prevent West Nile virus infection:
Questions about West Nile virus can be directed to the CDC's toll-free public hotlines:
English: 1-888-246-2675
Spanish: 1-888-246-2857
Hearing-impaired (TTY): 1-866-874-2646
Or e-mail to cdcresponse@ashastd.org.
The U.S. Customs Service and the FDA are investigating shipments of honey from China that may be contaminated with low levels of chloramphenicol, a potentially harmful antibiotic and unapproved food additive.
The agencies announced in August that inspectors discovered contaminated honey during an investigation into a widespread scheme to evade payment of U.S. anti-dumping duties on bulk imports of Chinese honey.
Dumping of a product occurs when merchandise manufactured outside of the United States is sold in the United States at a price below the cost of production or below the price sold in the foreign home market. Foreign manufacturers or importers sometimes dump products on the U.S. market to gain market share, because of political or social concerns, or to maximize profits and minimize losses in production.
In September 2000, several U.S. honey producers filed an unfair trade case alleging dumping of honey imports from China. In May 2001, the U.S. Commerce Department issued a notice that required customs to collect anti-dumping duties on imports of honey from certain Chinese companies.
The U.S. Customs attaché in Bangkok, Thailand, then received information that certain honey exports from China were allegedly being illegally transshipped through Thailand en route to the United States. The purpose of the alleged transshipment scheme was to circumvent payment of anti-dumping duties on Chinese honey imports in the United States.
As of September, the investigation had resulted in the detention of more than 50 containers of bulk Chinese honey at U.S. ports. Some of the bulk honey in these containers has tested positive for chloramphenicol, which is mostly used only to treat life-threatening infections in humans when other alternatives are not available. Use of the antibiotic is limited because it is associated with a very rare, but potentially life-threatening, side effect called idiosyncratic aplastic anemia. For the very small number of people susceptible to this side effect, exposure to chloramphenicol could be serious.
To protect the public from unnecessary exposure to potentially harmful substances, food and animal products containing chloramphenicol are illegal in the United States. The U.S. Customs Service is stopping all suspect bulk honey imports to this country for the FDA to determine whether they contain chloramphenicol. Any shipments containing chloramphenicol will be detained.
At this time, the FDA is unaware of contaminated honey being on retail shelves, but continues to investigate this matter. No illnesses have been reported in association with the imported honey so far.
In another effort to ensure that medications will be of the highest quality, the FDA has announced a new initiative that will enhance the regulation of drug manufacturing and product quality.
The initiative is designed to improve public health promotion and protection by focusing on three major goals that will augment the agency's drug product quality assurance programs across the board.
More than 40 years ago, Congress directed the FDA to require that all drugs be produced according to a good manufacturing practice (GMP) program. The requirement was in response to significant concerns about below-standard drug manufacturing practices at the time, and it prompted the adoption of modern quality assurance and control principles for drug manufacturing.
The goals of the FDA's new initiative will focus on the GMP requirements and will cover human and veterinary drugs and human biological drug products, such as vaccines.
The first goal will be to focus on potential risks to public health by providing additional regulatory attention and agency resources for those aspects of manufacturing that pose the greatest potential risk.
The second goal will be to help ensure that the FDA's essential work in establishing and enforcing drug product quality standards does not impede innovation and the introduction of new manufacturing technologies in the drug industry.
The third goal will be to make the FDA's approach to assuring production quality and safety among its regulatory centers and field operations more consistent and predictable.
The new initiative will be driven by the latest science and technology and will strengthen the public health protection achieved by the FDA's regulation of drug manufacturing, according to FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D.
The FDA has approved Hepsera (adefovir dipivoxil) tablets for the treatment of chronic hepatitis B in adults.
Hepsera slows the progression of chronic hepatitis B by blocking an enzyme needed for the virus to reproduce within the body. It is approved to treat adults who have evidence of active replication of the hepatitis B virus and either elevations in the liver enzymes alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or evidence of active disease.
Chronic hepatitis B is a serious disease caused by a virus that attacks the liver. The hepatitis B virus (HBV) can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. According to the Centers for Disease Control and Prevention, more than 1 million Americans are chronically HBV infected.
The FDA based its approval of Hepsera on the results of two randomized, double-blind, placebo-controlled studies. At week 48 of the studies, 53 percent of patients receiving Hepsera in one study and 64 percent of patients in the other study showed significant improvement in the liver inflammation caused by HBV, compared to 25 percent and 35 percent, respectively, of patients receiving a placebo.
In addition, people receiving Hepsera had less scarring of the liver compared to the placebo groups. Moreover, Hepsera has been shown to be effective in treating people with clinical evidence of HBV that is resistant to another approved antiviral therapy called lamivudine.
Major side effects associated with the use of Hepsera include kidney toxicity and severe, acute worsening of hepatitis B after discontinuation of Hepsera. People who have discontinued other approved products for the treatment of chronic hepatitis B also have experienced severe, acute worsening of hepatitis. This adverse event occurred in up to 25 percent of clinical trial participants after discontinuation of Hepsera.
Kidney toxicity was reported in people who are at risk of or who have underlying kidney dysfunction. In addition, there is a theoretical concern associated with Hepsera that resistance to HIV drugs could emerge in people with chronic hepatitis B with unrecognized or untreated HIV infection.
Gilead Sciences Inc. of Foster City, Calif., is the sponsor of the approved new drug application for Hepsera.
The FDA and the Food Safety Inspection Service (FSIS) are monitoring the food supply for possible increases in Listeria monocytogenes contamination, prompted by a recent increase in cases in the northeastern United States. Eating contaminated food products can cause miscarriages and stillbirths among pregnant women and can lead to serious and sometimes fatal infections (listeriosis) in newborns, frail or older people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea.
The Centers for Disease Control and Prevention (CDC) announced on Oct. 4 that analysis had indicated the leading suspect food in this outbreak is sliced turkey deli meat. Federal, state, and local health officials were continuing to investigate to determine the origin of the product involved. The FDA and the FSIS are issuing this advisory as they continue to work closely with the CDC and the states. Because of the number of cases and serious illness caused by Listeria monocytogenes, the agencies are providing the following information and advice to consumers.
People living in the affected region may reduce their risk of infection by not eating sliced turkey deli meats or by thoroughly heating them. In addition, people at risk for listeriosis and their family members or individuals preparing food for them should take the following precautions:
Consumers experiencing the symptoms described above or concerned about exposure should contact their physicians immediately.
Abbott Laboratories Inc., of Abbott Park, Ill., has begun a worldwide recall of 32 lots of laboratory kits used to diagnose gonorrhea. The test kits, which were distributed to hospitals and labs from Jan. 11, 2002, through June 24, 2002, have been shown to be unreliable because they may give false negative results.
Gonorrhea is a serious and highly contagious sexually transmitted disease. Untreated gonorrhea in women can cause pelvic inflammatory disease that can lead to sterility. In pregnant women, infection can cause abortion, premature delivery, or infection in the baby. Untreated gonorrhea in men can cause an infection of the urethra that makes urination painful and difficult. In both sexes, infection can spread through the bloodstream and infect the joints, skin, bones, tendons and other parts of the body.
People who have had a negative gonorrhea test since Jan. 11 may wish to ask their physicians if they should be retested. Abbott notified labs about the recall and asked them to discontinue use of all test kits and to destroy any remaining product. Abbott also advised labs to contact health-care providers served by their facilities to determine if patients need to be retested. The company will reimburse expenses associated with repeat testing.
Abbott voluntarily recalled the gonorrhea test kits after learning through routine internal testing that certain lots did not meet specifications and could report positive results as negative.
The 16 lots that failed to meet specification when tested by Abbott are:
84073M400; 84075M400; 84142M300; 84146M300; 85487M200; 87007M400; 87103M400;
87243M100; 87377M200; 87899M200; 87905M200; 88097M300; 88105M300; 88107M300;
88439M200; and 88439M201.
Patients who received a negative test result with test kits from these lots
may need to be retested. About 750,000 test kits are affected.
Consumers or labs with questions can contact Abbott Laboratories at 1-800-527-1869. Physicians who have questions on this recall should contact Abbott at 1-866-233-0471.
The FDA recently approved a wrist-watch-like glucose monitoring device for use by children and adolescents with diabetes. The device, which was approved for adult use in March 2001, provides information that can be used to detect trends and track patterns in blood glucose levels.
The GlucoWatch G2 Biographer, manufactured by Cygnus Inc. of Redwood City, Calif., extracts fluid through the skin and then measures the glucose in the fluid. Once the device has been warmed up and calibrated through the use of a finger-stick blood glucose test, it is capable of providing up to six painless glucose measurements per hour for 13 hours.
Because results with GlucoWatch can differ significantly and these variations are unpredictable, individual GlucoWatch readings should never be used to make changes in insulin dose. Instead, GlucoWatch results should be interpreted with several sequential readings over time and then confirmed with a finger-stick test.
Diabetes is a chronic disease that affects the body's ability to produce or respond to insulin. This can cause wide fluctuations in blood glucose levels, from extremely high to extremely low. More than 150,000 people under the age of 20 in the United States have diabetes, according to the Centers for Disease Control and Prevention.
The FDA's Andreas Keller, Ph.D., will serve as the United States' first "Americas Fellow" under a new exchange program announced by President Bush last year. This program sponsors exchanges of outstanding government officials from throughout the Western Hemisphere's democracies.
"HHS is proud to be among the first departments to take part in this important program to strengthen cooperation and understanding in the Americas," says Health and Human Services Secretary Tommy G. Thompson.
"We believe this program provides an excellent opportunity to advance the public health interest of all of the countries throughout our hemisphere," adds FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D.
Dr. Keller will use his expertise in microbiology to work with the Mexican government to improve agricultural and manufacturing practices, as well as to assist with imported produce safety initiatives--programs designed to benefit food safety on both sides of the United States-Mexico border. He currently is a consumer safety officer in the FDA's Center for Food Safety and Applied Nutrition.
The FDA has approved a high-intensity light to help clear up a specific type of acne.
ClearLight, which works only on inflammatory acne and not severe or mild cases, theoretically kills the bacteria inside pimples. The blue light is a different wavelength than skin-damaging ultraviolet light, and is thought to cause no side effects.
According to studies done, if the acne does not appear to be better after two or three 15-minute sessions, there is only a 10 percent chance it will respond to the treatment at all.
Currently, other options for acne patients include topical ointments, antibiotics, and drugs such as Accutane.
ClearLight is made by Lumenis Inc. in Israel.