|Weekly Update||November 8, 2010 |
FDA Boosting Enforcement Coverage for Adulterated Products
This article is reprinted from on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
David Elder, regional operations director in the Food and Drug Administration (FDA) Office of Regulatory Affairs explained in a question and answer session new FDA policies to insure drug and food safety as importation of products from overseas has increased dramatically in the past five years. He manages a team of investigators and analysts that works nationwide to ensure that imported regulated products meet FDA's standards, rules, and regulations.
Q: The number of imported goods that FDA regulates has increased by 35 percent in the past five years. What is FDA doing to ensure the safety of these products?
A:FDA has a team of more than 2,000 scientifically trained specialists who conduct inspections and investigations, collect and analyze product samples, oversee recalls, take enforcement actions, and monitor regulated products coming across our nation's borders.
The agency oversees the importation of the full range of regulated products, including food, animal feed, human and veterinary drugs, vaccines and other biologic products, cosmetics, and medical devices.
FDA electronically screens all import entries and performs more than 100,000 analyses on about 31,000 import product samples annually. During Fiscal Year (FY) 2009, we performed more than 210,000 examinations of imported goods in the field and conducted at least 1,196 foreign inspections.
FDA also administers more than 250 Import Alerts each year that help to prevent the entry of thousands of products that violate the Federal Food, Drug, and Cosmetic Act (FDCA) because they are contaminated, mislabeled, or otherwise not in compliance with the law.
Q: FDA inspects or samples less than 1 percent of all regulated products seeking entry into the United States. Why doesn't the agency do more?
A:The tremendous volume of imports-about $2 trillion worth of products each year from more than 230 countries-makes it impossible to physically examine every product entering the country. Instead, we use a targeted, risk-based approach.
We work to inspect the right imports-those that may pose a significant public health threat-and take additional preventative actions such as issuing import alerts.
FDA also works cooperatively with U.S. Customs and Border Protection and other agencies to help identify shipments that may pose a threat.
By law, certain information must be submitted to FDA about food products before they are allowed to enter the U.S. This information is collected and analyzed by our Prior Notice Center 24 hours a day, 365 days a year.
Q: What can consumers do to help protect themselves from potentially unsafe or ineffective imported products?
A:Consumers need to keep aware about the products they purchase. They need to be wary about buying prescription drug products over the Internet. The safety and effectiveness of drug products cannot be assured when they are bought outside of the control of the U.S. drug supply system. Also, drugs purchased outside the U.S. drug supply system may be counterfeit.
In addition, people who order foreign drugs online or by mail thinking they are saving money can often get comparable generic drugs in the U.S. for less money.
FDA recommends three specific steps:
- Buy only from U.S.-based and known Internet pharmacies. Consult a reliable source, such as the National Association of Boards of Pharmacies website.
- Do not buy prescription drugs from sites that do not require a prescription or have a pharmacist available for questions.
- Always consult your physician before taking any drug products.
Consumers can also stay updated on FDA's Imports Alerts online.
A good practice is to pay attention to media reports from FDA, the U.S. Department of Agriculture, and other government agencies to make sure you aren't using a recalled product or a product that is the subject of a consumer safety alert.
Also, actively participate in reporting problems with products you purchase. You can learn about this in the Consumer Update, "Your Guide to Reporting Problems to FDA."
Report: Anti-Counterfeiting Technology Needs Evolution, Global Implementation
A new study from Cambridge Consultants details some of the challenges facing developers of anti-counterfeiting technology, according to a new white paper written in coordination with the BIO 2010 conference in Chicago. Summarizing a panel discussion between Lew Kontnik, Director of Brand Protection for Amgen, David Kent, Vice President of Global Risk at Genzyme, Andrew Emmett, director for Science and Regulatory Affairs at BIO, and Hugh Burchett of Cambridge Consultants, the paper reviews current anti-counterfeiting technology - including anti-tamper packaging, serialization and authentication - and concludes all technologies must operate with collaboration among manufacturers, the supply chain and law enforcement to be effective.The report, which was written as a result of a panel on anti-counterfeiting technology at the 2010 BIO International Convention, highlights the need for new measures to continuously evolve and to wholly integrate with business practices. (Partnership for Safe Medicines, November 3, 2010; Link here)
The white paper is available on Cambridge Consultants' website.
Canada: Canadian Websites Selling Counterfeit Drugs to the Public
Health Canada has identified three websites that are selling prescription drugs not authorized for sale in Canada, the agency said Wednesday. The websites - www.northdrugmart.com, www.northdrugstore.com and www.pharmacyrxworld.com - sell products containing references to brand names and resemble drugs that are approved for sale in Canada, products which Health Canada said it suspects are counterfeit. "It is important to note that counterfeit drugs may contain no active or unsuitable ingredients, or dangerous additives. To this end, counterfeit drugs may pose a higher risk than other forms of unauthorized drugs," the department said in a news release. If the websites continue to sell unauthorized health products, Health Canada said it will act to enforce the regulation. ("Websites selling counterfeit drugs, Health Canada warns," CBC, November 3, 2010; Link here)
Ghana: 11% of Nation's Children Under 5 Die - More Can Live if Counterfeit Drugs are Reduced
Ghanaian religious leaders committed to decreasing child mortality rates decried counterfeit drug purveyors at the 8th Annual National Catholic Health Services Conference (NCHS). The NCHS annual conference was instituted to create a forum for Catholic Church health institutions to share common and peculiar concerns and experiences. The National Catholic Health Service (NCHS) is partnered with the Institute for Healthcare Improvement (IHI) to run Project Fives Alive! to reduce morbidity and mortality in children less than five years old in Ghana. Funding for the Project comes from the Bill and Melinda Gates Foundation.Ghana's children suffer 110 deaths for each 1000 children under five years of age, or 11%. One of the most common sources of mortality is malaria. Anti-malarial drugs are among the most common counterfeited in Africa and Southeast Asia where malaria is pervasive. (The Partnership for Safe Medicines, November 5, 2010; Link here)
Nigerian Operation Closes More than 1,200 Illegal Pharmacies
Local Nigerian authorities recently shut down more than 1,200 illegal pharmacies in Lagos for selling substandard and counterfeit drugs. The Lagos State Task Force on Counterfeit, Fake Drugs and Unwholesome Processed Foods reportedly shut down 1,253 illegal pharmaceutical outlets at Idumota, at the Lagos Central Business District (LCBD) on Lagos Island, according to the newspaper the Nigerian Compass. The state Commissioner for Health Dr. Jide Idris said that the large operation was part of Nigeria's efforts to protect its citizens by ridding the country of counterfeit drugs. "The raids by the men of the state task force on counterfeit, fake drugs and unwholesome processed foods was necessitated by the persistent defiance of government's stipulated regulation on drug production, importation, manufacture, sales or display for sales, hawking, distribution, adulteration, and possession of drugs by illegal operators," Idris told the news source. (Partnership for Safe Medicines, October 30, 2010; Link here)
Anti-Counterfeiting Americas (Boston, USA)
When: Monday, Nov 8, 2010
Description: PSM Executive Director Scott LaGanga is speaking at this conference.
Building Pharmaceutical Anti-Counterfeiting Programs (Los Angeles, CA)
When: Wednesday, Nov 10, 2010
Where: University of Southern California (map)
Description: A one day course from the USC Regulatory Science Program and the Food and Drug Law Institute. For more information or to register see the USC page
International Conference of Drug Regulatory Authorities (Singapore)
When: Tuesday, Nov 30, 2010
Where: Singapore (map)
About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org