FDA, along with other federal and international agencies, cracks down on illegal Internet pharmacies
SILVER SPRING, Md. — The Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found that most of the examined packages contained illegal prescription drugs that had been ordered from online sources.
These actions took place in support of the 7th annual International Internet Week of Action — May 13 to May 20, 2014 — sponsored by Interpol, and also known as Operation Pangea VII. During Operation Pangea VII, law enforcement, customs and regulatory authorities from 111 countries collaborated to identify the makers and distributors of illegal drug products and medical devices that used the Internet to sell their products and remove these products from the supply chain.
Operation Pangea VII‘s coordinated efforts at mail facilities resulted in the detention or seizure of 19,618 packages containing medicines purportedly from Australia, the U.K., New Zealand and Canada. These packages actually contained unapproved or suspected counterfeit drugs from other countries, such as India, China, Singapore, Taiwan, Mexico, Laos, Malaysia, as well as Australia, New Zealand and the U.K.
The FDA and the CBP inspected packages at the mail facilities in Los Angeles, New York and Chicago, and detained or seized 583 packages. Preliminary findings show that certain drug products from abroad, such as insulin, estrogen, bimatoprost, human chorionic gonadotropin, tramadol, tadalafil and sildenafil citrate were on their way to U.S. consumers. The FDA also notified internet service providers, domain name registrars and related organizations that 1,975 websites were selling products in violation of U.S. law.
“When consumers buy prescription drugs from outside the legitimate supply chain, they cannot know if the medicines they receive are counterfeit or even if they contain the right active ingredient in the proper dosages,” stated Douglas Stearn, director of the FDA‘s Office of Enforcement and Import Operations. “Consumers have little or no legal recourse if they experience a reaction to the unregulated medication or if they receive no therapeutic benefit at all. In addition to health risks, these pharmacies pose other risks to consumers, including credit card fraud, identity theft or computer viruses.”
Investigations and operations such as Operation Pangea VII have revealed that many American consumers order medicines from online sources believing they will receive the same medicine as the U.S. approved version. These medicines, however, are often unapproved or counterfeit and from countries with less stringent manufacturing standards or regulatory controls. Many illegal online pharmacies purport to sell drugs identical to the U.S.-approved versions to attract consumers but then send them unapproved, counterfeit or substandard versions.
“Many illegal online pharmacies use slick website templates and empty guarantees to convince U.S. consumers that the inexpensive drugs they sell are the exact same prescription drugs that are dispensed in the U.S.,” said Philip Walsky, acting director of the FDA‘s Office of Criminal Investigations. “The FDA will continue to leverage our resources and strengthen our national and international partnerships to shed light on these Internet-based fraudulent activities which target consumers.”
The FDA provides consumers with information on how to identify an illegal pharmacy website and advice on how to find a safe online pharmacy through BeSafeRx: Know Your Online Pharmacy.
The IIWA is a collaborative effort between the FDA, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry and national health and law enforcement agencies from 111 participating countries.
JAMA: Antibiotic prescribing rate for acute bronchitis at 70% when it should be zero
CHICAGO — Despite clear evidence of ineffectiveness, guidelines and more than 15 years of educational efforts stating that the antibiotic prescribing rate for acute bronchitis should be zero, the rate was about 70% from 1996 to 2010 and increased during this time period, according to a study in the May 21 issue of JAMA.
"Avoidance of antibiotic overuse for acute bronchitis should be a cornerstone of quality health care," stated Michael Barnett, co-author from the Brigham and Women’s Hospital, Boston. "Antibiotic overuse for acute bronchitis is straightforward to measure. Physicians, health systems, payers and patients should collaborate to create more accountability and decrease antibiotic overuse.
Acute bronchitis is a cough-predominant respiratory illness of less than three weeks’ duration. For more than 40 years, trials have shown that antibiotics are not effective for this condition. Despite this, between 1980 and 1999, the rate of antibiotic prescribing for acute bronchitis was between 60% and 80% in the United States. During the past 15 years, the Centers for Disease Control and Prevention has led efforts to decrease prescribing of antibiotics for acute bronchitis. Since 2005, a Healthcare Effectiveness Data and Information Set measure has stated that the antibiotic prescribing rate for acute bronchitis should be zero, according to background information in the article.
Researchers found that of 3,153 sampled acute bronchitis visits between 1996 and 2010 that met study inclusion criteria, the overall antibiotic prescription rate was 71% and increased during this time period. There was a significant increase in antibiotic prescribing in emergency departments. Physicians prescribed extended macrolides (a type of antibiotics) at 36% of acute bronchitis visits, and extended macrolide prescribing increased from 25% of visits in 1996 to 1998 to 41% in 2008-2010. Other antibiotics were prescribed at 35% of visits.
Teva receives FDA nod for QVAR
JERUSALEM — Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.
The counter will help asthma patients and their caregivers keep track of the number of remaining doses in the canister. It will be commercially available later this year, according to the company.
“Inhaled corticosteroid treatments, like QVAR, should be taken daily by patients with mild-to-moderate persistent asthma to reduce inflammation in the airways and prevent asthma symptoms,” said Dr. Gene Colice, director of pulmonary, critical care and respiratory services at Washington Hospital Center in Washington, D.C. “By using QVAR with a dose counter, patients will be able to easily track their daily doses of medication and help ensure that they are taking QVAR as prescribed by their doctor.