Partnership for Safe Medicines Supports Stronger Online Pharmacy Regulation
WASHINGTON (June 25, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding yesterday's House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security hearing on “Online Pharmacies and the Problem of Internet Drug Abuse” and the proposed “Ryan Haight Online Pharmacy Consumer Protection Act of 2008” (H.R. 6353 and S. 980).
The Partnership for Safe Medicines commends the members of this subcommittee and Representatives Stupak, Smith and Bono Mack for addressing a major safety issue associated with online drug access—the sale of controlled substances over the Internet without a valid prescription.
Unfortunately, mandating prescriptions for drugs purchased online will not be enough to stop this public health threat. Internet drug peddlers will simply bridge the gap by creating and selling fake prescriptions. Rogue online drug sellers enable drug abusers to purchase their drug of choice and endanger consumers by passing off counterfeit medications.
One of the Partnership’s core principles for drugs safety is that we must regulate online pharmacies. We value the rigorous oversight and standards that govern traditional pharmacies in the United States and believe all online drug sellers should be held to the same standards. We advocate that no one should be able to purchase any type of prescription drug, not just controlled substances, over the Internet without a valid prescription. That is why we endorse the Verified Internet Pharmacy Practice Site (VIPPS) accreditation program created by the National Association of Boards of Pharmacy. All Internet drug vendors, regardless of which state or country they are based in, must comply with the pharmaceutical licensing and survey requirements for every state they send pharmaceuticals.
Unscrupulous online businesses will continue to sell whatever to whomever, as long as they are paid. If we truly want to avoid another deadly incident of failed Internet drug safety, we urge Congress to take this opportunity to further address the vulnerabilities threatening the safety of our prescription drugs. To learn more about how we can protect our supply chain, regulate online pharmacies, fight counterfeit drugs and other principles of drug safety, please visit SafeMedicines.org
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. To join us in our stand against counterfeit drugs or obtain your own copy of the Principles for Drug Safety doctrine, please visit SafeMedicines.org.
The Threat Keeps Rising
On a daily basis, many individuals unknowingly risk death or serious injury to their health by taking counterfeit drugs. As executive director of the Pharmaceutical Security Institute (PSI), I see first-hand how counterfeiters thrive in countries where the anti-counterfeiting laws are weak; the drug regulatory agencies are underfunded and understaffed; and legal sanctions are ineffective.
Earlier this spring, PSI completed its review of the worldwide situation and began briefing law enforcement and drug regulators as to the nature and extent of this threat. As I shared with Bloomberg News, a recurring theme this year was more—more incidents involving more types of drugs in more countries. Specifically, in 2007 we saw a total of 1759 incidents of counterfeit, stolen or illegally diverted drugs; 24 percent more than we found in 2006. The number of countries reporting incidents also increased (from 100 to 112) and the types of drugs these criminals are targeting rose more than 14 percent. Last year, counterfeiters sold 639 different types of branded, generic and over-the-counter drugs and used improved packaging to make their fake goods harder to detect.
But more also applies to the good news—more arrests (up 39 percent), more international cooperation, more organizations taking a stand against counterfeit drugs, more countries recognizing the inadequacy of their anti-counterfeiting resources and more governments taking steps to address these shortcomings.
In my last entry, I shared with you the Partnership’s new Principles for Drug Safety doctrine. In it, we called on the United States and the international community to unify in the fight against counterfeit drugs. Around the world, individual countries are beginning to understand that fake drugs are a global public health hazard that requires an international solution.
Still, serious challenges remain and the need for a unified front is stronger than ever. In the meantime, keep visiting SafeMedicines.org to learn how we can work together to protect the safety of our prescription medicines.
Consumer Protection Group Supports IP Enforcement to Combat Counterfeit Drugs
WASHINGTON (June 17, 2008) – The Partnership for Safe Medicines issued the following statement regarding today's Senate Judiciary Committee hearing on “Protecting Consumers by Protecting Intellectual Property.”
The Partnership for Safe Medicines applauds the Committee for recognizing that enforcement of intellectual property (IP) laws are an important way to combat the sale of unsafe or substandard products, such as counterfeit pharmaceuticals. Time and time again, we have seen imitations of FDA-approved drugs contaminated with harmful or unsafe materials, as well as counterfeits containing nonstandard amounts of active ingredients that affect the integrity of the medication.
One of the Partnership’s core principles for drug safety is that we must unify in the fight against counterfeit drugs. We believe the United States needs to be a leader in this global fight. We must advocate for better cooperation between government agencies here within the United States, as well as with our counterparts around the world, in order to prosecute the unscrupulous counterfeiters who do not hesitate to use foreign, even toxic, materials in their products.
Counterfeit drugs defraud consumers and deny ill patients therapies that can alleviate suffering and save lives. The harm and fatalities from counterfeit and contraband medicines must stop. The Partnership supports increasing criminal penalties against the perpetrators of counterfeit medicines to reflect the gravity of their offenses. Additionally, we endorse granting the FDA the authority to destroy unapproved drugs entering the United States rather than returning them to the criminals who sent them here.
If we truly want to avoid another deadly incident of failed drug safety, we urge Congress to take this opportunity to further address the vulnerabilities threatening the safety of our prescription drugs. To learn more about how we can protect our supply chain, regulate online pharmacies, fight counterfeit drugs and other principles of drug safety, please visit SafeMedicines.org—because counterfeit drugs are unsafe at any cost.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. To join us in our stand against counterfeit drugs or obtain your own copy of the Principles for Drug Safety doctrine, please visit SafeMedicines.org.
Principles for Drug Safety
After years of neglect, it’s refreshing to see Congress giving drug safety the attention it deserves. But as my colleague Dr. Shepherd said last month, policy makers must view these efforts as the beginning of improving our supply chain, not the end.
If Congress and the FDA truly want to avoid another deadly incident of failed drug safety, our policy makers must take this opportunity to address the other vulnerabilities threatening the safety of our prescription drugs.
The Partnership for Safe Medicines has developed three core principles to support quality assurance programs and establish a drug distribution system that is without compromise. These principles include:
1. Protect Our Supply Chain
2. Closely Regulate Those Selling Pharmaceuticals Online
3. Unify in the Fight Against Counterfeit Drugs
We believe the United States needs to be a leader in the global fight against counterfeit drugs. To join us in our stand against counterfeit drugs or obtain your own copy of the Principles for Drug Safety doctrine, please visit SafeMedicines.org.
Desperately Needed FDA Funds on the Way
I’m not sure I understand the reluctance of our Federal agencies to identify their resource needs. In the case of counterfeit medicines, this is a serious problem which affects all Americans. Those charged with protecting our medicines should frankly state their needs.
Thankfully, the FDA has recognized the need for more funding and asked for it. They announced that an extra $275 million was required to fulfill its mission of protecting food and drug safety – with up to $20 million allocated to boosting the agencies overseas presence by opening two offices aboard. And better still, the Senate acted swiftly and has already approved the extra funding in an amendment which has been sent to the House.
If passed, the funds will be available through the end of fiscal 2009. But it’s not a slam dunk. The FDA’s funding is in one of three measures (the other two have to do with the war in Iraq). And no one can predict when the House will vote on the legislation which means further delays for the agency’s funding.
But, I’m hopeful. Hopeful that these critical resources will be provided. Hopeful that they will help in the fight against counterfeit and contaminated medications. Hopeful that these actions will bring us one step further in safeguarding America’s drug supply.
As we wait for Congress to approve the funding, keep visiting
SafeMedicines.org to learn how we can work together to protect the safety of our prescription medicines.