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.

While a good-intentioned idea, the Partnership for Safe Medicines (PSM) believes that "Pharmaceutical Market Access and Drug Safety Act of 2009" will undermine nearly two decades of drug safety policy.  Throughout the past 16 years and under two administrations, no HHS Secretary—Democrat or Republican—has certified a drug importation plans—a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.

Unfortunately, this legislation simply does not recognize the increasing vulnerability of the international supply chain. In fact, it would allow importation from several countries that have had recent problems with counterfeit drugs in their own country.  In the past three months alone, the Medicines Health products Regulatory Agency (MHRA)—the British equivalent of the U.S. Food and Drug Administration (FDA)—has issued two recalls for counterfeit insulin pens and inhalers .  The European Union’s 2007 pharmaceutical counterfeiting data shows that almost 40 percent of fake medicines seized by the E.U. originated in Switzerland.  And according to the Pharmaceutical Security Institute (a member of the Partnership for Safe Medicines), last year, there were 104 reported incidents of counterfeit medicines in Japan, while Germany and Austria were in the top 10 countries where counterfeit drugs were most frequently seized or discovered.

Any time consumers are subject to drugs from outside of the U.S.’s currently closed drug supply chain, there is a very real risk to their health and welfare.  Foreign pharmacies are not subject to the FDA’s jurisdiction and the exporting countries’ equivalents of the FDA are not going to spend their limited resources scrutinizing drugs not earmarked for their citizens.  It is both impractical and not their legal responsibility. Additionally, criminals continually use European parallel importation and trade laws to slip counterfeit drugs into the legitimate supply chains of member countries that allow it, such as the United Kingdom.  Finally, there is no evidence that drug importation provides any real savings according to the Congressional Budget Office and independent academic analysis.

Read the rest of this entry on importing drug safety policy here.

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 .

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Democratic Senator Byron Dorgan said that Majority Leader Harry Reid had promised to bring the drug importation measure to a Senate vote “very soon.” Dorgan said he expected the vote to happen within “a matter of a couple weeks.”

Last week, Dorgan said he planned to offer the importation measure as an amendment to a pending bill that would grant the Food and Drug Administration power to regulate cigarettes.

Read the rest of this article on drug safety here.

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.

The PPA, a nationwide effort sponsored by America’s pharmaceutical research companies, provides a single point of access to more than 475 patient assistance programs that help those who are uninsured or struggling financially. Nearly 200 of the programs are provided by pharmaceutical companies.

Read the rest of this article on prescription assistance programs here.

A 34-year-old housewares designer in the St. Louis area, Hubbard had recently gotten married. She liked the creativity of her career. And she’d conquered her mild depression and fatigue with a combination of exercise, rest and medicine, including the antidepressant Wellbutrin XL. But in the fall of 2006, shortly after she refilled her prescription — her pharmacy giving her this time Budeprion XL, a generic version of the drug — her good health gave way.

Read more about this safe medication issue here.

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The Partnership for Safe Medicines (PSM) strongly suggests that the only way to curb the sale and distribution of counterfeit drugs is to introduce warnings and reprimands against dangerous online drug sellers and then to follow up and make sure they stop.  Yes, it is important for consumers to understand that eating Cheerios® is not the solution to lowering cholesterol.

Read the rest of this article on counterfeit drugs here.