Pharmaceutical Regulatory News Headlines - Week of October 31, 2008

In the United States, Halloween is the day for Tricks and Treats. But - Globally regulatory authorities have Penalties not Treats for would be counterfeiters.

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. Global regulatory authorities are now recognizing the increasing threat these fraudulent products place on their citizens and are taking legal actions to discourage it:

Saudi Arabia: Local Markets Flooded with Counterfeit Drugs
Agreements were made on Tuesday to step up legal action against counterfeiters in Saudi Arabia to ensure consumer safety. According to Abdullah Al-Abdelgader, a pharmaceutical manufacturing director, counterfeit drugs account for around 30-40 percent of medicines sold at local pharmacies and hospitals in Saudi Arabia and expose consumers to great risk. In the Gulf area, the counterfeiting economy accounts for $13 billion, with a share of $4 billion in the Saudi market. ("Some 30-40% of Medicines Sold Locally 'Are Counterfeit', Says Manufacturer," Saudi Gazette, October 22, 2008)

FDA Oversight of Foreign Drugs Lacking
The Food and Drug Administration is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections, according to a report by the Government Accountability Office. The House Energy and Commerce Committee introduced a bill that would mandate foreign inspections at a rate close to that of FDA inspections of U.S. plants. U.S. companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years. ("FDA Is Faulted for Oversight of Foreign Drugs," Wall Street Journal, October 21, 2008)

Nigeria: Government Takes Steps to Block Counterfeit Drugs
The National Agency for Food and Drugs Administration and Control (NAFDAC) has blocked 22 Indian pharmaceutical companies from importing and distributing drugs in Nigeria. The agency has outlawed the use of about 40 imported drugs in the country, describing them as potentially dangerous for human consumption. As part of its efforts to curb drug counterfeits, NAFDAC is advocating for greater public education and awareness. ("Fake Drugs: NAFDAC Bans 22 Indian Firms," AllAfrica.com, October 22, 2008)

XStream Systems thinks that its penetrating authentication technology can be an integral part of the comprehensive solution to this global problem.

Economic Downturn Means Counterfeit Medications Likely to Increase

As the economies around the globe continue to teeter and decline, it seems apparent that those same dynamics will trigger an increase in the criminal enterprises that deal in counterfeit medications.

This next year, we anticipate a sharp increase in reported instances of counterfeit pharmaceuticals discovered within the pharmaceutical supply chain.

“All of the economics drivers that are driving the economy down, give counterfeiters the perfect environment to flourish, “stated Alan Clock, Senior Vice President at XStream Systems. “Consumers and healthcare providers that are looking for cheaper medications often look outside of the secure sources and can easily fall prey to unscrupulous suppliers who may be selling counterfeit or adulterated medications.”

As consumers look for value in purchasing medications, it is important to buy products from established, licensed drug stores. Only buy products on-line that are affiliated with a national chain drug store or licensed pharmacy benefit organization.

Most importantly, remember, if it sounds too good to be true…it probably is. Let the buyer beware, especially when you are buying your medications in a troubled economy.

XStream Systems Stories and News for the Week of October 24, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Demand for Foreign Products Changing FDA, Official Says
The FDA needs to shift its approach on imports to one that minimizes risk at each point in the product life cycle — from foreign manufacture to domestic use, according to Timothy Ulatowski, director of compliance in the agency’s Center for Devices and Radiological Health. The FDA will release a draft guidance soon that outlines standards for third-party certification programs for FDA-regulated products, he said. It also is preparing a draft guidance on good importer practices.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.

FDA To Open Multiple Inspection Offices Abroad By Year-End
The U.S. Department of Health and Human Services will send the first FDA inspection teams to new offices in China, India, Europe, and Latin America before the end of 2008, according to HHS. "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partner, including China," stated HHS Secretary Mike Leavitt.

FTC Breaks Up Spam Network Which Illegally Sold Drugs Online
The Federal Trade Commission said Tuesday that it has broken up a global spam network responsible for sending billions of illegal messages encouraging consumers to buy unsafe male-enhancement and weight loss pills. The spam network, which processed credit card information in Cyprus and Georgia, used servers in China to host its websites. The FTC said the network used by this operation compromised tens of thousands of computers around the world and was capable of sending up to 10 billion spam messages per day. The bogus drugs were shipped from China and India.

XStream Systems Stories and News for the Week of October 17, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Study Finds Prescription Drug Packaging Varies In Quality
The quality of prescription drug packaging from leading manufacturers varies considerably, according to a study by Pharmacy Healthcare Solutions Inc. (PHSI), a finding that could affect the integrity of the medications contained in them.

Bush signs anti-counterfeiting bill
President Bush signed a bill creating an intellectual property czar to beef up U.S. enforcement of laws against pirated and counterfeited products, including pharmaceuticals.

New Zealand: Death Highlights Dangers of Ordering Drugs Online
Earlier this year, Graham David Goodwin of Blenheim died after taking drugs that included an anti-depressant he had ordered online and had mailed to him. As a result, Parliament is being urged to crack down on the illegal importation of prescription medicines.

Sex Doctor Sold Dodgy Tablets
Dr George Patino, 48, dubbed the “King of Viagra” was jailed for his part in a multi-million pound fake medicine ring. He sold thousands of counterfeit impotence tablets to customers across the world.

Pharma Execs Ask - How Can I Halt Counterfeit Drugs?

That’s the question of many in the pharmaceutical industry. How can I secure my brand? How can I be sure that counterfeits don’t infiltrate my supply chain? How can I minimize my risk? And……What are the breaking technologies available in pharmaceutical authentication and supply chain security?

To discuss these questions, leading executives are planning to attend The Center for Business’ Premier Forum on Anti-Counterfeiting and Anti-Diversion Strategies October 20-21, 2008 in Vienna, VA. Regulatory officials, pharmaceutical organizations, and solution providers will be presenting various perspectives on the problem.

Alan Clock and John Lundquist from XStream Systems will be speaking on authentication technologies and how they can be implemented and integrated with existing safeguards to provide a comprehensive solution against counterfeit, adulterated and tampered drugs.

If you would like to register or would like more information on the event, please visit www.cbinet.com.

Largest European Seizure: Two Million Counterfeit Pills Seized in Brussels Airport

Two million counterfeit pills have been seized in Brussels Airport. The seizure of the drugs which originated in Mumbai, Indian and were bound for West Africa is the largest confiscation of counterfeit medicine in Europe.

The three Indian shipments contained counterfeit pharmaceuticals labeled as Tramal, a painkiller, and Fansidar, an anti-malaria drug.

Africa already has the daunting task of trying to control its malaria outbreaks without further obstacles of fake treatments. Many countries, organizations, and businesses have been aiding Africa to fight malaria and therefore, counterfeit medicine is a real threat to their work. In some countries up to 60% of anti-malaria drugs are fake and are aiding in the drugs resistance to current therapies.

Furthermore, the biggest victims are the children, because according to the Worlds Health Organization (WHO) a majority of malaria deaths are children under the age of five and Fasidar is one of the drugs given to pregnant women for the prevention of malaria.

The scope and intent of this particular case leads us to ask – Is any medication safe? How can we protect our most vulnerable medications? We believe the answer can be found in pharmaceutical authentication which verifies the drug itself. With nothing added and nothing destroyed; the method can be programmed to test various oral medications.

To learn more of this fascinating technology, see XStream Systems website at http://www.xstreamsystems.net/products.html.

Schwarzenegger Terminates the Momentum of E-Pedigree in California

In a story reported in Drug Store News, Tuesday, California Governor Arnold Swarzenegger signed a bill which essentially pushes back the deadline for compliance of e-pedigree requirements within the supply chain until 2017.

Given the seriousness of the threat of counterfeit, adulterated and contaminated medications within the US pharmaceutical supply chain it is apparent that manufacturers, distributors and dispensers still need to take precautions to protect their drug inventories.

XStream’s EDXRD technology allows each member to independently protect itself from counterfeit and adulterated medications without an elaborate and expensive process that only tracks the transaction.

California governor signs e-pedigree bill,

SACRAMENTO, Calif. - Gov. Arnold Schwarzenegger handed California pharmacies a major victory Tuesday, signing into law a bill that gives the state's drug retailers some breathing room in their effort to comply with electronic pedigree and track-and-trace technology requirements for prescription drugs.

Schwarzenegger signed into law SB 1307, which revised the technology requirements for establishing the origin and movement of prescription drugs through the supply chain. Included in the law is a provision that pushes back the deadline for compliance for California pharmacies from Jan. 1, 2011, to Jan. 1, 2017.

The decision reflects the recommendations of pharmacy leaders for a gradual and more workable implementation process for new e-pedigree requirements. A number of pharmacy representatives testified before the Enforcement Committee of the California State Board of Pharmacy, asking for an extension that would allow them enough time to adopt the track-and-trace technology needed to establish every drug's pedigree.

California warns Residents not to flush pharmaceuticals

What happens to your unused pharmaceuticals? Many consumers are concerned with the increased numbers of pharmaceuticals showing up in our drinking water. Some states are answering this issue with collection and or recycling programs.

The California state and local officials are teaming with the U.S. Environmental Protection Agency for a "No Drugs Down the Drain Week," starting with events Oct. 2. The program recommends that drugs be dropped at special collection sites or tossed in the trash.

Some states collect unused drugs and then destroy them and according to according to the National Conference of State Legislatures, 36 states have recycling programs for prescriptions to be redistributed to needy individuals. The regulations for these states vary, but the general provisions for recycling are as follows:

• All donated drugs must not be expired and must have a verified future expiration date.
• Controlled substances as defined by the federal Drug Enforcement Administration are usually excluded and prohibited.
• A state-licensed pharmacist or pharmacy must be part of the verification and distribution process.
• Each patient who receives a drug must have a valid prescription form in his or her own name.

On the surface this is at the least a protection for our environment, and at the most a fine humanitarian effort…but the only safe way that drugs can be properly recycled and properly dispensed for those in need is to make certain that they are authentic by using a non-destructive verification process.

XStream Systems, XT250 is designed to authenticate and verify materials inside its container without degrading or destroying the material.
Save the environment and help those in need, recycle drugs by authenticating them.