Jan 15, 2009 - The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.
The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today.
"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, Director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "This is one of several agency initiatives to enhance drug product safety."
Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.
"With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate U.S. laws," said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at FDA. "Consumers should know that only companies that maintain control over their products will be selected into this pilot program."
Companies wishing to participate in the two year pilot program must meet certain criteria, including:
For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
The active pharmaceutical ingredients imported must be used only to make FDA‑approved drugs;
Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
Applicants must show that their drug products use a secure supply chain.
Jan 15, 2009 - This draft guidance provides importers with recommendations to assist them in preventing or detecting potential problems at critical points along the product’s life cycle,” said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning, U.S. Food and Drug Administration.
Recommendations in the draft guidance are designed to anticipate potential sources of product hazards and offer preventive controls firms can implement to mitigate such hazards and help ensure imported products are safe and are compliant with U.S. requirements.
These draft Good Importer Practices are broadly organized under four guiding principles:
Establishing a product safety management program
Knowing the product and applicable U.S. requirements
Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements
The draft guidance recommends that importers consider instituting practices to identify and minimize risks associated with imported products. The draft guidance also recommends that, in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors; understand the products that they import and the vulnerabilities associated with these products; understand the hazards that may arise during the product life cycle, including all stages of production; and ensure proper control and monitoring of these hazards.
The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States
Jan 15, 2009 - Blacks make up 12 percent of the U.S. population, but account for about 70 percent of gonorrhea cases and almost half of chlamydia and syphilis cases, the Centers for Disease Control and Prevention said.
Black women ages 15 to 19 have the highest rates of chlamydia and gonorrhea, and gonorrhea rates for blacks overall were 19 times higher than for whites, the CDC said.
Dr. John Douglas, who heads the CDC's division of sexually transmitted disease, or STD, prevention, said overall syphilis, chlamydia and gonorrhea rates are unacceptably high. Cases of these three STDs are reported by U.S. states to the CDC.
In 2007, 1.1 million U.S. cases of chlamydia were reported, up from about 1 million in 2006 and the most ever, and the rate rose by 7.5 percent from the prior year, the CDC said in a report. Douglas said the figures may reflect that more people
are being diagnosed rather than a rise in infections.
In addition, more than 350,000 cases of gonorrhea were reported in 2007, essentially unchanged from 2006, the CDC said. Gonorrhea rates fell dramatically from the mid-1970s through the mid-1990s, with little progress since.
Chlamydia and gonorrhea are easily diagnosed and treated, but frequently have no symptoms and remain undetected.
Untreated, chlamydia and gonorrhea -- both bacterial infections -- can cause pelvic inflammatory disease and infertility in women. The two infections also can cause ectopic pregnancy, chronic pelvic pain and other health problems.
"Of all the causes of infertility, this is probably the most preventable -- since these infections can be prevented, diagnosed and treated," Douglas said in a telephone interview.
In men, gonorrhea can cause a painful condition of the ducts attached to the testicles that cause infertility. Gonorrhea also can spread to the blood or joints and can be life threatening. Chlamydia complications among men are rare.
Douglas said to avoid STDs, teens can delay the beginning of sexual activity, people can limit the number of sexual partners and use condoms. "Condoms have risk-reduction value for every sexually transmitted condition," Douglas said.
Syphilis is less common than the others, with 11,466 cases reported in 2007. Rates rose 15 percent from 2006. Syphilis rates dropped by 90 percent in the 1990s to a record low level in 2000, and officials thought it might disappear as a public health threat before its resurgence this decade.
Syphilis has increased each year since 2000 -- its rate is up 81 percent -- with gay and bisexual men representing 65 percent of cases, the CDC said.
Douglas said many cases are occurring in HIV-positive men who are choosing other HIV-positive men as sexual partners.
"Within that relationship, they are less concerned about the transmission of other conditions. They're not using condoms. They believe that their partner already has got the worst they can get -- they've got an HIV infection," he said.
When all STDs are considered, including human papillomavirus (HPV or genital wart virus) and herpes simplex viruses, almost 19 million new infections occur each year, with nearly half among those ages 15 to 24, the CDC said.
Jan 01, 2009 - “With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research.
Nucleic acid is the common name for the large chemical compounds that make up the genetic material in living cells. The new FDA-approved test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.
In addition to HIV-2 and HIV-1 Group O, the MPX test simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the Hepatitis C Virus and the Hepatitis B Virus.
The MPX test is designed for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma. Donated source plasma is considered plasma intended for further manufacturing.
The test is also intended for screening tissue specimens obtained while the donor’s heart is still beating; it is not intended for use on specimens from donors whose heart no longer functions.
Dec 31, 2008 - Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this.
“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.
Prostate cancer is one of the most commonly diagnosed cancers in the United States. In 2004, the most recent year for which statistics are currently available, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer.
Several treatment options exist for different stages of prostate cancer including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors.
The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.
In fact, nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.
The most frequently reported adverse reactions in the clinical study included injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.
Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany.
