Recognizing that pharmaceutical safety as an issue of vital importance, the United States of America today revealed efforts to improve pharmaceutical safety around the globe.
In his remarks at the Global Forum on Pharmaceutical Anti-Counterfeiting and Diversion in Washington DC, Under Secretary Robert D. Hormats says the Department of State is working with, and fully supporting, the FDA. And, together, engaging USAID, Homeland Security, Justice, Commerce, and other USG agencies to address the problem.
“We do so because the problem is vast and multi-faceted.” – Mr. Hormats
According to Mr. Hormats, until the early-20th century, medicines were neither safe nor effective.
“There’s a quote by a famous 19th century physician, Oliver Wendell Holmes, Sr. “who was also Dean of Harvard Medical School” that highlights this point. Holmes commented that: “if all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes.” – Mr. Hormats
In his remarks, Mr. Hormats focuses on three themes related to this problem:
(1) why the United States and, specifically, the Department of State have taken an active role to stop the spread of counterfeit and substandard medicines;
(2) activities in which US is engaged to promote pharmaceutical safety; and
(3) areas where drug manufactures, supply chain experts, health ministry officials, and medical regulatorsa'”can continue and reinforce your leadership.
Mr. Hormats reports that unsafe medicines were rampant in the United States until the early 20th century.
Recognizing that governments have an important and inherent role to protect their citizens from harm, Mr. Hormats says President Franklin Roosevelt signed the Food, Drug, and Cosmetic Act in 1938, which created the Food and Drug Administration.
The FDA has done a tremendous job ensuring that the medicines we take are safe and efficacious, he highlighted.
However, the world has changed since the agency was created, he added.
He reports that approximately 80 percent of manufacturers of active pharmaceutical ingredients used for medications marketed in the United States are located overseas.
Because of this interconnectedness, unscrupulous or criminal manufactures in any country can threaten the well-being of Americans and, indeed, citizens of many other countries, he pointed out.
To improve pharmaceutical safety around the globe, Mr. Hormats says the Department of State’s safe medicines strategy has three prongs.
“Raising awareness is the first component of our approach.” – Mr. Hormats
He says broadcasting the dangers of counterfeit and substandard medicines and is critical to safeguarding pharmaceutical supply chains in the United States and in other pharmaceutical supplier and consumer countries.
Over the past two years, the State Department has funded 24 outreach efforts throughout Africa, Asia, Europe, the Middle East and South America, Mr. Hormats reported.
“The second pillar of our safe medicines strategy is focused on stopping counterfeiters themselves.” – Mr. Hormats
He adds that these criminals sell their wares without regard for patients who may be harmed in the process.
The US has funded a series of government-to-government training programs in collaboration with other U.S. government agencies, the private sector, and NGOs.
He says these programs help foreign law enforcement, customs, and judicial officials catch and prosecute traffickers of counterfeit medicines.
“The third pillar of our safe medicines strategy is multilateral engagement.” – Mr. Hormats
A substandard batch in one country can adversely impact dozens of countries, he noted.
And, in the case of counterfeits, criminals capitalize on legitimate trade to sneak fake medicines across international borders, he explained.
“Therefore, a global approach is necessary.” – Mr. Hormats
That’s why, as this year’s chair of the G8 summit, the United States successfully encouraged heads of state meeting at Camp David to acknowledge the threat of counterfeit medicines to public health and consumer safety, Mr. Hormats noted.
In addition, the State Department also pushed for cooperation against the spread of counterfeit and substandard medicines at the Asia-Pacific Economic Cooperation, or APEC, Forum.
“And, the United States is active in the World Health Organization on this matter.” – Mr. Hormats
The US has participated in the WHO’s working group on substandard, spurious, falsely-labeled, falsified, or counterfeit medical products meeting last week in Argentina.
“The U.S. government is using a number of different approaches.” – Mr. Hormats
The US is increasing awareness, helping build enforcement and regulatory capacity, and working through international organizations to develop global solutions.
The US has underscored that counterfeit medicines hurt people and endanger lives.
Counterfeiters do not care about a patient’s health when selling fake, tainted, poisonous, or sub-standard forms of life-sustaining medicines. Moreover, they are not interested in whether the patient is taking other medications or if the combination of medications will result in an adverse reaction.
Experts report that there has been a 700 percent increase in drug counterfeiting from 2002 to 2009.
In 2009, the United States identified counterfeited versions of over 800 unique medicines, ranging from antibiotics to cardiovascular drugs to anti-cancer therapies.
According to US government, the counterfeit, falsified, and substandard medicines are not a hypothetical problem. The results can be tragic. In the United States 81 patients died from contaminated Heparin in 2010. There have been reported deaths in China due to counterfeit and sub-standard medicines as well.
The United States has stringent statutory, regulatory, and enforcement regimes to protect consumers against dangerous counterfeit, unapproved, or illegally prescribed pharmaceuticals.
The United States is committed to continue to fight against the spread of counterfeit and sub-standard medicines as well.