Crop protection products play a crucial role in bringing abundant and affordable food to our dinner tables. Forty percent of the world’s food supply would not exist without products like atrazine, a herbicide that helps farmers fight weeds in their corn, sorghum and sugar cane crops.

After 50 years of use, growers have come to rely on atrazine. It is a mainstay of American agriculture. And it is one of the best studied herbicides available today. Safety reviews around the world by the US Environmental Protection Agency (EPA), World Health Organization, Canada, Australia and the UK have all come to the same science-based conclusion—atrazine, as labeled, can and has been used safely.

Atrazine is a critical tool for use in conservation tillage and no-till systems—farming methods that eliminate plowing and/or reduce tillage. Conservation tillage makes cropland much less vulnerable to soil erosion, which is reduced by as much as 90 percent when compared to intensive tillage. When soil erosion is prevented, so is the runoff into our waterways of sediment—identified by EPA as the top pollutant in US streams and rivers.

Farmers would not use a product that puts their own families and communities at risk, and after half a century, who would know better? Today, in part because of atrazine, farmers are able to grow more corn than ever, using environmentally sustainable methods. That means more food to feed a growing population.

Syngenta is a responsible company which takes the stewardship of all our products seriously—and atrazine is no exception. We’ve gone above and beyond the extensive studies required to register this product to ensure its safe and effective use. And as with all crop protection products, wide margins of safety exist with atrazine.

It’s easy to believe fear-provoking claims about our nation’s water when all the data and facts aren’t presented. Let’s be clear - water systems in the U.S. are safe where atrazine is concerned. Over the last three years, no water systems in the U.S. had atrazine levels in their drinking water that exceeded legal limits.

Read the rest of this article here.

None of the 122 community water systems monitored last year in 10 states where atrazine is used most exceeded the federal standards set for atrazine in drinking water or raw water

• The federal lifetime drinking water standard for atrazine is set at 3 parts-per-billion — a level containing a 1,000-fold safety factor
• The EPA concluded that the triazine herbicides – including atrazine – pose “no harm that would result to the U.S. population”

As a popular herbicide in more than 60 countries around the world, atrazine has been carefully studied for years. In 2008, none of the 122 community water systems monitored in 10 states where atrazine is used most exceeded the federal standards set for atrazine in drinking water or raw water.

“Atrazine can be occasionally detected in water at extraordinarily low concentrations (parts per billion ), but these low levels pose no threat to human health. A person could drink thousands of gallons of water containing 3 parts per billion atrazine every day for a lifetime, and still not be affected by atrazine,” said Tim Pastoor, Ph.D., principal scientist for Syngenta.

The U.S. Environmental Protection Agency (EPA) sets very conservative standards for chemicals in drinking water that are protective of human health. In the case of atrazine, EPA adopted a federal lifetime drinking water standard for atrazine is set at 3 parts-per-billion (ppb) — a level containing a 1,000-fold safety factor.

In raw (unprocessed) water, atrazine concentrations also declined significantly between 1994 and 2006 at 103 frequently monitored sites. This is due in large part to the best management practices growers now use with waterways and buffer strips. These practices have done much to protect water quality over the last 15 years.

Syngenta continues to work closely with growers in many watershed projects and in other stewardship programs to ensure that atrazine is used according to EPA guidelines and best management practices.

Atrazine recently underwent a rigorous, up-to-date safety evaluation by the EPA and was re-registered for use in agriculture. In 2006, the EPA looked at all of the triazine herbicides together — atrazine, simazine and propazine — and determined they pose “no harm that would result to the general U.S. population, infants, children or other major identifiable subgroups of consumers.”

Read the rest of this article here.

Bryan A. Liang, MD, PhD, JD

Earlier this year, Reps. John D. Dingell (D-MI 15), Frank Pallone, Jr. (D-NJ 06) and Bart Stupak (D-MI 01) introduced the Food and Drug Administration Globalization Act of 2009 (H.R.759).  This legislation indicates that Congress is beginning an important journey to address several real threats that substandard and counterfeit drugs pose to the pharmaceutical supply chain.

The bill incorporates a number of the Partnership for Safe Medicines’ Principles for Drug Safety and also introduces a Quality Risk Management Plan, which outlines specifications for safeguarding drug and medical devices, including:

• An assessment of companies contracting with a person to supply raw materials or ingredients;
• Monitoring and review through periodic on-site audits of the production facility’s conditions its controls and practices;
• Monitoring incoming materials; and
• Implementation of systems to ensure the appropriate specifications, test methods and verification of the drug ingredients’ identity, quality, strength, and purity.

The proposal also asks for authority to implement stronger enforcement tools, including:

• Destruction of counterfeit imports if they pose a risk of injury or death;
• Monetary and criminal penalties against offenders;
• Mandating the FDA to recall and detain unsafe drugs; and
• Allowing the FDA to subpoena records related to possible violations.

Read the rest of this article on counterfeit drugs on safemedicines.org.

April 8, 2009

President Barack Obama
1600 Pennsylvania Avenue, NW
Washington, DC 20500

Dear Mr. President,

On behalf of the Partnership for Safe Medicines (PSM) , a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines and dedicated to the safety of the drug supply, I would like to congratulate you on your efforts to improve health care and expand meaningful coverage for the millions of Americans who lack it. However, PSM is deeply concerned that the most vulnerable run the highest risk of encountering counterfeit, adulterated, or unsafe medicines and believe a comprehensive approach is needed to solve this patient safety problem.

We believe that safety must be our top national priority in any health reform effort. However, with respect to prescription drugs, today Americans unknowingly risk death or serious injury to their health by taking counterfeit drugs. Counterfeit drugs impact virtually every country in the world (including 115 in 2008) and virtually every disease state. Indeed, in 2008, there were at least 651 different types of counterfeit branded, generic and over-the-counter drugs discovered. Over the last several years, with improved appearance and packaging, these criminals have made their fake goods even harder to detect.¹ This is clearly a growing global problem and requires many new types of international collaboration for effective investigation and interdiction.

Issue: Importation
In addition, this drug safety issue also has particular relevance to the debate on prescription drug importation into the U.S., one of several proposed cost-saving measures under consideration by Congress. I applaud your administration’s choice to study the issue before proceeding and would ask that any analysis focus upon several areas, including:

1. Lack of Regulation for Products Trans-Shipped Through "Safe" Countries such as Canada and U.K. Drug importation advocates believe that drugs purchased from countries such as Canada and the UK are safe because of their strict health regulations. Unfortunately, this is simply not true. For example, Health Canada clearly states drugs not earmarked for Canadians are not subject to the Canadian government’s safety regulations. Hence, drug exporters can bypass Canada’s safety regulations and mail fake or low-quality drugs made in high risk countries such as China and India to Americans without Health Canada’s oversight. Likewise, the UK indicates it lacks the power to stop suspected counterfeits on its shores destined for the U.S. because these goods are only transiting through the country. Indeed, recent conflicting E.U. rulings have resulted in U.K. customs now not stopping nor inspecting goods transiting through, allowing counterfeit medicines to move through the U.K. and into the U.S. undetected.

2. Inability for Importation to Satisfy US Demand and Foreign Provider and Citizen Resistance. There are simply not enough legitimate drugs in foreign supply chains to satisfy U.S. demand. For example, if just half of elderly Americans shifted their purchases to Canadian sources, it would exhaust the entire Canadian drug supply in a few months. Hence, both Canadian providers and citizens oppose U.S. importation. In addition, this reality could have considerable impact for our political and economic relationships with smaller countries like New Zealand, Czech Republic, Romania and others, whose supply could be devastated by parallel traders exporting most of their supply to the U.S.

3. Inaccurate Safety Perceptions for Foreign Risky Purchases. A drug importation policy will give Americans an inaccurate—indeed, dangerous—perception that buying drugs from any "Canadian pharmacy" is safe because "the government is allowing drug imports." This is particularly true for patients buying drugs through high-risk Internet drug sellers.

4. US Policy in Hands of Foreign Governments. Congressional importation proposals would place our drug policy in the hands of foreign governments. Price, quality, oversight (or lack thereof), and other critical issues will be defined by other governments without concern for U.S. patient protection and with unclear potential for safety regulation or enforcement. It would also reduce security of the supply chain to the weakest global link. The U.S. would effectively rely on the Asian, Baltic, and Balkan region countries to serve as our “border patrol” against counterfeit drugs. However, these countries do not have sufficient knowledge or capacity to do so and will prioritize the needs of their own citizens with the scarce regulatory resources they have.

5. Virtually No Cost Savings. The Congressional Budget Office estimates in its 2004 drug importation issue brief that reduction in drug prices from importation would be "small" or "only about 1% … [and] permitting importation only from Canada would produce a negligible reduction in [drug spending." Any savings would be virtually nonexistent because middlemen will reap all the profits and leave little, if any, savings for consumers. The reality is that prescription drugs from a safe, secure drug supply chain—regardless of whether or not it allows drug importation—will always be more expensive that those from an unsecured, potentially fraudulent supply chain.

Proposed Policy
Considering these risks, we urge you to educate Congress about the need to guarantee the safety of prescription drugs. This affects all of us, but our most vulnerable patient populations, such as minorities, seniors and fixed income patients would bear the brunt of any policy failure. Instead, we need to focus on creating substantive programs that maintain access to safe medicines by using the closely regulated and inspected U.S. supply chain. This could include:

1. Offshore FDA Support and Authority. The FDA needs funding and authority to develop programs and systems that tighten the drug supply chain. In order to stop counterfeit drugs and other unsafe products from pouring out of foreign manufacturing facilities and into the U.S., the FDA needs to establish more foreign field offices and staff them with both inspectors and criminal investigators armed with the same authority as their State-side colleagues. This includes the authority to enter and inspect foreign manufacturing facilities without previous notice.

2. Onshore FDA/Agency Support and Authority. The U.S. currently has 300 custom ports of entry, but the FDA only has 200 port inspectors and only 17 inspectors to cover all international mail centers. We must hire more inspectors here and grant the FDA and other agencies the authority to destroy unapproved and counterfeit drugs entering the US rather than returning them to the criminals who sent them here—our current policy.

Read the rest of this entry on prescription drug safety here .

The cost of counterfeiting is much more than money.  In too many cases, counterfeiting costs human health and in some cases lives.  For example, a group of clinics in Sierra Leone were closed last week for allegedly administering counterfeit drugs.  Other cases involving online drug sellers have claimed the health and lives of patients who bought from illicit Web sites.

Recently, the U.S. Department of Commerce and U.S. Chamber of Commerce released the Top 10 Ways to Protect Yourself From Counterfeiting and Piracy , contributing to the protection of consumers from the harms of counterfeit goods.  Like many of the recommendations in our Consumer Resources , this list outlines ways consumers can take an active role in protecting themselves from all types of fake goods, including counterfeit drugs, by:

• Paying attention to questioning labels and packaging
• Identifying safe sellers, by visiting the U.S. Chamber’s Supply Chain Tool Kit , and for online pharmacies, looking for a seal of accreditation from the Verified Internet Pharmacy Practice Sites (VIPPS)
• Insisting on secure transactions
• Watching for absent sales tax charges
• Being cautious when purchasing products from abroad

Read the rest of this article on counterfeit drugs here.