In a July 22 letter, the Food and Drug Administration (FDA) reminds health professionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud and counterfeiting.
“Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison with health professionals, says in the letter. “The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/IUSs highlights the unacceptable risk patients may be exposed to when a product’s identity, purity, source, handling, and storage cannot be verified.”
Still, patients can use their FDA-approved IUDs with confidence, Toigo says.
FDA experts say women who received unapproved IUDs from practitioners in Rhode Island, Massachusetts, and Kentucky could be at an increased risk for unwanted pregnancy.
The small, T-shaped devices—often made of flexible plastic or copper wire—are inserted into a woman’s uterus to prevent pregnancy. Some IUDs also deliver small amounts of hormone as added protection from pregnancy.
FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth control—such as condoms, birth control pills, or the patch—and contact their health care professional. Women may want to ask:
What advantages are there for keeping my IUD in?
Should I think about having my IUD removed?
If I keep my IUD in, how long should I use another form of birth control?
If I want my IUD removed, can I get a new, FDA-approved one?
I don’t want to use condoms. Will other birth control products, such as the pill, patch, or ring, be equally effective?
Will this affect my ability to get pregnant in the future?
What should I do if I think I’m pregnant?
Nationwide Problem
What started out as a Rhode Island investigation has spread beyond the state’s borders. The FDA is aware of the use of these unapproved products in several states and is continuing to investigate.
FDA says doctors, nurses, midwives—and possibly patients themselves—might buy unapproved products from what appear to be Canadian or other foreign websites in a bid to save money. Purchasing medical products from websites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA-approved and could be manufactured in other countries.
“Unapproved products bring a lot of unknowns into the equation,” says FDA compliance officer Kathleen Anderson. “An Internet ad may claim to sell IUDs made in Canada, but there’s no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions.”
Advice for Consumers
FDA investigators routinely monitor the Internet for the sale of unapproved drugs and devices in an effort to protect the public, but the rapidly growing number of websites trafficking in fraudulent medical products means consumers must remain alert.
Experts advise consumers to learn how to buy health-related products safely over the Internet. Legitimate Internet pharmacies are licensed by the appropriate state board of pharmacy and follow laws and regulations of the state where they operate.
Legitimate Internet pharmacies will also display a seal from the National Association of Boards of Pharmacy—known as VIPPS seal or Verified Internet Pharmacy Practice Sites. VIPPS pharmacies are listed at vipps.nabp.net/verify.asp4.
FDA is also asking the public to report information about the distribution of unapproved IUDs. To contact the agency’s criminal investigators visit www.fda.gov/oci5.
This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.
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.
