NCL urges caution following HHS drug importation announcement

December 20, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – The National Consumers League (NCL)urges caution in light of this week’s announcement on drug importation from the Department of Health and Human Services. Our primary concerns are that this proposed new rule will put the public at greater risk of counterfeit drugs while not clearly passing on any cost savings on to consumer.

NCL recently launched the Fake Rx Action Center in conjunction with our site Fraud.org, which aims to educate consumers on the risks posed by counterfeit medicines, and how to spot, avoid, and report them should consumers come across any fakes. Counterfeit medicines have already claimed lives across the country, and this proposal further endangers consumer health by undermining the security of the American pharmaceutical supply chain.

Opening the door for states, pharmacies, and distributors to obtain medications beyond U.S. borders means that consumers could more easily fall prey to bad actors from around the globe when being provided medications that have originated outside of the U.S. regulated manufacturing and distribution supply chain. As the World Health Organization has noted regarding the broader counterfeit issue, patients may end up with medications that have the wrong active ingredient, the wrong amount of active ingredient, no active ingredient, or dangerous added ingredients. While we will continue to advocate for access to affordable drugs, it is not clear from the regulations that any potential cost savings from obtaining medications outside the U.S. borders will be passed on to individual consumers. The goal of lowering prices for consumers without a clear assurance of out of pocket cost savings in these regulations is not worth increasing the risk of harm to consumers by exposing them to medications that may not meet the clear standards of U.S. law.

Our organization has put consumers first for more than 100 years. It is our belief that there are safer and more effective ways to provide access to necessary prescription medications than to expose Americans to potentially deadly counterfeits originating outside the United States.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL announces new action center to help patients steer clear of deadly counterfeit drug websites

December 5, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL), America’s pioneering consumer advocacy organization, today launched Fraud.org/FakeRx, a new digital consumer education campaign to address the growing global crisis of harmful counterfeit medications. The World Health Organization estimates that one in every 10 medical products circulating in developed countries is either substandard or fake, and nearly $83 billion in counterfeit drugs are sold annually. Counterfeit drugs can be, at best, a waste of money and, at worst, fatal.  The Partnership for Safe Medicines has found counterfeit pills made with fentanyl in 48 states, with deaths attributed in 33.

“Counterfeit drugs are everywhere, and they are dangerous. Going to the Internet to buy medicines is a bad idea if you don’t know how to protect yourself from illegal pharmacies selling counterfeit drugs. Consumers do not realize how common counterfeits are; our campaign aims to provide the tools and resources to help consumers steer clear of illegal products and protect themselves and their families,” said NCL Executive Director Sally Greenberg. “NCL is launching Fraud.org/FakeRx to serve as a hub for reliable information for consumers and law enforcement.  Our action center helps consumers learn how to spot the red flags of counterfeit drugs and report issues to law enforcement.”

With the growth of Internet sales of medications, the problem of illegal pharmacies hawking counterfeit drugs is a growing risk to consumers. Visitors to Fraud.org/FakeRx can arm themselves with information to:

  • Reduce the chances they’ll encounter counterfeit drugs and shop safely for medications online
  • Learn to spot harmful counterfeit drugs if they do; and
  • Report counterfeit drugs and the websites offering them to the authorities fighting the problem.

“Criminals posing as legitimate online pharmacies are a serious threat to our nation’s drug supply and to unsuspecting consumers who purchase contaminated or potentially deadly counterfeit medications,” said George Karavetsos, former director of the U.S. Food and Drug Administration’s Office of Criminal Investigations. “Policymakers, regulators, and manufacturers have clear roles for doing their part to protect our drug supply, but having informed consumers is essential to shutting down this illegal online market. This campaign gives consumers the tools they need to stay safe and keep criminals from lining their pockets with consumers’ money.”

NCL has worked with victims of suspected and confirmed counterfeit drugs to capture their experiences and report them to authorities. Two mothers who each lost their adult children to tainted counterfeit medications have lent their stories to the new campaign in hopes of helping others avoid falling to the same fate.

“I lost my son, Jerome, himself a loving big brother and father of three beautiful children, to a counterfeit drug laced with fentanyl. It took one single pill to take Jerome away from us,” said Natasha Butler, whose son was one of a wave of victims of counterfeit drug deaths in Sacramento in 2016. “We had no idea that these dangerous drugs, manufactured to look exactly like the real thing, are out there and could be the last drug someone ever takes. Anyone who takes medication or fills prescriptions needs to be aware of the risks of counterfeits, and that where you get drugs is so crucial for your safety and health. Everyone should visit Fraud.org/FakeRx to learn about the risks and how to avoid being the next victim.”

 “On June 11, 2018 my phone rang at 7:24 am. The voice on the other line told me that my beautiful daughter, Ashley, was dead. Ashley had been given a counterfeit pill laced with fentanyl. I was told by the coroner that she probably died instantly,” said Andrea Thomas, a Colorado mother who, since her daughter’s death from a counterfeit drug, co-founded Voices for Awareness Foundation. “The deadly pill Ashley took looked just like her normal medication. This is an epidemic in our country that I previously knew nothing about. It is time to take action. The National Consumers League’s new resources for consumers will help spread awareness and will make a difference to many.”

To hear from additional victims who know the issue firsthand, visit the new Fraud.org/FakeRx. The site also includes tips for consumers about ways to save on prescription drugs without increasing their risks of purchasing counterfeits. 

NCL thanks its partners for providing support for the new campaign: Allergan, Celgene, Eli Lilly, Gilead Sciences, Pfizer, and PhRMA.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

AAOA and National Consumers League Raise Awareness About Prescription Opioid Abuse Safety

October 16, 2019

Media contact: press@againstopioidabuse.org or National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Alexandria, VA—Allied Against Opioid Abuse (AAOA) and the National Consumers League (NCL) released a new suite of resources to help educate consumers about prescription opioid safety. The AAOA-NCL Consumer Toolkit provides materials to help reinforce the need for patients, caregivers, parents and others to understand their rights, risks and responsibilities associated with prescription opioid use.

Education plays a crucial role in helping consumers understand the importance of safely using, storing and disposing of prescription opioids,” said Sally Greenberg, Executive Director, NCL. “We are pleased to partner with AAOA on this important set of resources, which will provide individuals with actionable steps that they can take to keep prescription opioids secure and prevent misuse and abuse of these medicines among family and friends.”  

The AAOA-NCL Consumer Toolkit addresses common questions that patients may have about their rights, risks and responsibilities associated with prescription opioids, and highlights facts about opioid medications to fill a knowledge gap and prevent misuse before it occurs. The toolkit includes the following resources:

AAOA has taken a leading role in sharing information and fostering communication between patients, consumers and the medical community to help reduce prescription opioid abuse,” said John Parker, Senior Vice President of Communications for the Healthcare Distribution Alliance, the founding member of AAOA. “By leveraging NCL’s expertise, our goal is to communicate directly with consumers about the important role everyone has to play in ensuring the appropriate use, storage and disposal of prescription opioids.”  

In August, the AAOA-HealthyWomen Toolkit was released to help educate women, in their role as consumers and caregivers, about what they can do to prevent the misuse and abuse of prescription opioids in the home. To learn more about AAOA’s resources, including a series of videos that raise awareness about prescription opioid safety, visit www.AgainstOpioidAbuse.org/Act.

For press inquiries, contact press@againstopioidabuse.org

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About Allied Against Opioid Abuse
Allied Against Opioid Abuse is a national education and awareness initiative to help prevent abuse and misuse of prescription opioids. Founded by the Healthcare Distribution Alliance, the initiative is a collaborative effort with diverse partners across the pharmaceutical supply chain, as well as organizations that are experts in public health and healthcare, including Alliance for Aging Research, American Pharmacists Association, American Physical Therapy Association, BeMedWise, Caregiver Action Network, Gerontological Society of America, Healthcare Leadership Council, HealthyWomen, Men’s Health Network, Mental Health America, National Alliance of State Pharmacy Associations, National Association of Directors of Nursing Administration, National Association of States United for Aging and Disabilities, National Community Pharmacists Association, National Consumers League, National Transitions of Care Coalition, Pharmacy Technician Certification Board, and the PA Foundation. Our goal is to contribute to solving the opioid crisis in a meaningful way by educating patients about their rights, risks and responsibilities. To learn more, visit www.AgainstOpioidAbuse.org or follow us on Twitter: @AAOA_Tweets.

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL statement on White House pathway for drug importation

August 2, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—As the nation’s pioneer consumer organization, the National Consumers League (NCL) strongly supports consumer access to safe, effective, and affordable prescription drugs. The recent announcement by the White House to open a pathway for importation of drugs from outside of the United States seems unworkable and poses safety and purity challenges.

Six years ago, the U.S. government enacted a safe system to “track and trace” drugs sold to U.S. consumers through the Drug Supply Chain Security Act. The law required, that by 2023, all drugs sold to U.S. consumers must have both a product identifier and a unique package code to allow Food and Drug Administration (FDA) and any buyer in the supply chain to obtain a comprehensive history of where the drug was manufactured and packaged. This secure supply chain system best ensures consumers are receiving medications that are not counterfeit or substandard.

“The recent announcement by the White House ignores the Drug Supply Chain Security Act and undermines the security of the U.S. pharmaceutical supply chain,” said Sally Greenberg, NCL executive director. “This new pathway for importation could easily lead to counterfeit or substandard drugs finding their way to consumer’s medicine cabinets, thus putting patient health and safety at risk.”

In addition to the safety risks posed by this new policy announcement, there are no guarantees that it will save consumers money. The proposal opens the door for states, pharmacies, and distributors to obtain the medications outside of U.S. borders, but it does not require that any cost savings from obtaining those “lower-priced” medications be passed on to consumers. So, even if safety concerns could be addressed, it is not clear that there will be any direct cost savings benefit to consumers.

The threat to public health is real. Counterfeit medications may contain the wrong active ingredient, the wrong amount of the active ingredient, no active ingredient, harmful ingredients, or even poisons such as mercury, road tar, or antifreeze. Counterfeit medications made with deadly ingredients have been found in more than 40 states across America, posing a significant public health threat.

“Allowing importation will only serve to exacerbate the challenge of preventing counterfeit drugs from reaching American patients,” said Greenberg.

NCL continues to advocate for more responsible strategies to ensure the affordability and accessibility of safe and effective prescription drugs.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Imposters, information theft, and internet scams: the dangers of unregulated online pharmacies – National Consumers League

By NCL Food Policy and LifeSmarts Caleigh Bartash

With technology improving rapidly over the past few decades, online retailers have proved more convenient, reducing the market share of brick-and-mortar retailers. However, the convenience of purchasing prescription medication online or over the phone can inadvertently trap consumers in internet scams.Countless issues can arise from ordering prescription medication online. Unapproved internet dealers often evade government recognition or detection, failing to comply with drug safety regulations. Consumers can receive counterfeit, contaminated, or expired drugs. In some cases, these drugs may contain deadly opioids like fentanyl. Unauthorized medications can also have varying amounts of a medicine’s active ingredient — if they contain the correct ingredient at all.

Consumers may be attempting to access medications that they have previously been prescribed. However, they face security threats as soon as they give their personal details to an illegitimate pharmacy. These sellers have poor security protections, with leaks of sensitive customer information all too common. Illegitimate online sellers may even outright sell consumer data to scammers. Moreover, these websites can trick unsuspecting consumers into downloading viruses which further risk personal property and information.

Counterfeit drugs, unauthorized data sharing, and cyber attacks are dangerous, but now, a new threat has emerged involving counterfeit letters from the U.S. Food and Drug Administration.

Last week, the FDA released a press announcement alerting consumers to fraudulent warning letters claiming to be sent from the government. They advised that any consumer who received a warning message is likely the victim of a scam.

The July 2018 FDA press announcement is unique in that it is targeted directly to consumers. Commonly, these warning letters are used as a tool to inform the public about drug safety issues and are typically sent exclusively to manufacturers and companies creating products under their jurisdiction. FDA commissioner Dr. Scott Gottlieb summarized the FDA’s policy, stating “we generally don’t take action against individuals for purchasing a medicine online, though we regularly take action against the owners and operators of illegal websites.”

What’s next for those that received a warning letter? The FDA requests that potential victims contact them with information, including pictures and scanned documents if possible, in an effort to help them investigate the scams. Consumers can use the email address FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov as the primary channel for communicating with the agency about suspicious warnings.

The best way to avoid falling victim to any scam involving illegal internet pharmacies is to abstain from suspicious websites. How do you distinguish fake internet pharmacies from safe ones? The FDA offers guidance with their BeSafeRx campaign. Asking a few simple questions at the doctor’s office or calling a certified pharmacist can help consumers protect themselves. Safe online pharmacies usually offer information including address, contact information, and state license. Consumers should be wary if the pharmacy does not require prescriptions to access pharmaceutical drugs. Other warning signs include international addresses, clear spam messages, and unreasonably low prices.

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Have more questions about fraud? NCL’s Fraud.org site has prevention tips, an outlet for consumer complaints, and an experienced fraud counselor to teach you how to avoid common scams. And for those wanting to learn more about proper medication consumption, our Script Your Future initiative has helpful advice and information so you can navigate your prescriptions with the utmost confidence.

Vaccine-averse ‘Hotspots’: A danger to all – National Consumers League

By Melissa Cuddington, NCL public policy intern

Think that measles has been eradicated from the United States? Think again. According to a report published earlier this month by PLOS Medicine, measles is still spread by unvaccinated children and foreign visitors to the United States. This spread is seen in “hotspots,” otherwise known as areas where the risk of disease is higher because parents choose to abstain from getting their children vaccinated. Parents continue to claim non-medical exemptions for issues of philosophy, and that’s dangerous.

A recent Washington Post article shined a light on the growing problem the anti-vaccination movement is creating: 18 states still allow parents to opt their children out of school immunization requirements. These hotspots are located across the country both in urban, metropolitan locations, such as Houston, Austin, and Pittsburgh and in rural areas as well.

In many of these urban centers, too many children are being exempted from immunization requirements, making it easier for vaccine-preventable diseases to spread and infect others. The Post article notes that these urban centers have busy airports, opening up the possibility for diseases to spread to the un-vaccinated.

According to a study conducted by the Centers for Disease Control and Prevention (CDC), people who remain unvaccinated are most likely the cause of the increased occurrence of measles and other contagious diseases being spread throughout the United States. The CDC also predicts the reemergence of these diseases if parents continue to skirt vaccination requirements.

Many of these diseases from the past are easily preventable if parents get their children vaccinated at a young age. Medical research shows that if children do not receive the measles vaccination (MMR) 12 to 15 months after birth, they are at risk of exposure.

Sadly the anti-vaccination movement in the United States has been going strong. At some point, parents need to consider that the decision not to get their child vaccinated is not just personal—it’s a communal one. The choice to abstain from vaccination puts vulnerable adults and children at risk. As the research demonstrates, this decision could expose others to possibly fatal diseases, which are entirely preventable with immunization.

As a consumer advocacy organization that champions vaccinations for all who can safely be vaccinated, NCL pushes against these non-medical exemptions. It is dangerous for parents to be making decisions for their children that can have adverse effects on others. NCL encourages state and federal health officials to support laws that don’t allow personal preference to prevent children from being immunized. California’s law is a good model and would keep us all safe from totally preventable diseases.