Showing posts with label The Partnership for Safe Medicines. Show all posts
Showing posts with label The Partnership for Safe Medicines. Show all posts

Thursday, July 17, 2025

Fake HIV Medicine Finds Its Way into NYC Pharmacies

By: Ranier Simons, ADAP Blog Guest Contributor

Counterfeit medication is a serious threat to public health in 2025. There have been numerous warnings issued over fake cancer drugs, fake Botox, and more recently, counterfeit GLP-1s. While obscure online pharmacies and other non-traditional sources remain easy access points for fake drugs, they are increasingly infiltrating the legitimate supply chain. On several occasions in recent years, the HIV drug supply chain has been at the center of counterfeit drug schemes, often perpetrated by nefarious actors using gay dating apps, like Grindr and Jack'd. And now, according to an alert by the Partnership for Safe Medicines, alleged fake HIV medicines have been found in a New York City pharmacy.

Counterfeit Drugs: A Growing Public Health Threat
Photo Source: American Medical Women's Association

Gilead Sciences has been a repeat victim of counterfeit drug schemes over the past few years. In 2021, taking advantage of the COVID-19 pandemic, counterfeiters targeted Gilead’s remdesivir. The investigation revealed that a significant portion was coming from Mexico and Turkey (Gilead Sciences, n.d.). In 2022, Gilead filed a lawsuit against a ring of counterfeiters selling over 85,000 fraudulent bottles of its HIV antiretrovirals Biktarvy and Descovy (Walker & Ramey, 2022). Although Gilead has seized thousands of bottles of counterfeit drugs from unauthorized distributors and won lawsuits, the harm continues. A U.S. District court in New York recently unsealed another complaint filed by Gilead Sciences.

A patient contacted Gilead because the bottle of Biktarvy they purchased from their local pharmacy was short by eight pills. Upon investigating the bottle, Gilead discovered that the label was a high-quality fake. The lot number on the bottle was outdated, and the expiration date was falsified. The packaging was a well-done counterfeit, as it contained only a minor typo, and the print resolution of the branding was only moderately off. Alarmingly, the patient had already consumed all the pills; thus, it was impossible to know if the pills in the bottle were Biktarvy or some other substance (Gilead vs. City Plus, 2025). Notably, evidence showed that the contents were filled by the counterfeiters, not Gilead. In past counterfeit transgressions involving Gilead medications, bottles were filled with medications other than the ones intended to be in them. Taking medications not prescribed to a patient could result in adverse effects ranging from overdoses of unnecessary medications to the advancement of disease states because of non-treatment with the proper drug.

A retail pharmacy and its principals, were caught red-handed dispensing fake BIKTARVY
Photo Source: Partnership for Safe Medicines

The most pertinent issue of the lawsuit Gilead is filing against the pharmacy that sold the counterfeit drug is that the pharmacy’s owner and operators will not voluntarily reveal the source of the fraudulent medication (Gilead vs. City Plus, 2025). As Gilead points out in the complaint, “Any legitimate pharmacy would be horrified to learn it had dispensed counterfeit HIV medicine and would do all in its power to identify the source of the counterfeit and stop it from happening again. The Defendants here instead obstructed Gilead’s investigation and refused to provide any information about the counterfeit they sold” (Gilead vs. City Plus, 2025). The fake packaging is very sophisticated and requires expensive equipment. Thus, Gilead explains that the elaborate effort indicates a larger counterfeit manufacturing scheme. Gilead accuses the pharmacy of participating in the counterfeiting and distribution of fraudulent medications, not just Biktarvy, but also others, given the sophistication of the machinery necessary to create the fake packaging.

Gilead Sciences is poised to suffer significant monetary losses due to the sale of counterfeit medications, as well as potential damage to its brand and reputation. However, the most alarming issue is the danger to public health (Gilead vs. City Plus, 2025). Hiding the source of the counterfeit medications delays the stoppage of the flow of harmful medications into the drug supply. The investment necessary to procure the labeling and printing equipment used to create the fake Biktarvy means that other medications are likely being counterfeited on a large scale. In addition to the cessation of selling any Gilead-branded medications, whether legitimate or counterfeit, and punitive damages, Gilead Sciences demands the destruction and impounding of the pharmacy’s Gilead-branded supply. It also demands that the offending pharmacy turn over all documentation associated with the purchase and sale of Gilead-labeled medications.

Counterfeiters target expensive and widely utilized medications, other than just HIV antiretrovirals. "This is another benefit of the Drug Supply Chain Safety Act (DSCSA) for patient safety. The DSCSA created a standard way to trace medicine, and a standard way for honest pharmacies to prove their innocence," said Shabbir Imber Safdar, Executive Director of the Partnership for Safe Medicines. He added, “This standardization of documentation means that a supply chain member who has strayed from the safe supply chain cannot stall investigators for weeks hiding their crime." Popular targets are painkillers, antibiotics, and ‘lifestyle’ drugs. In April 2025, the FDA issued a warning about several hundred units of counterfeit Ozempic it had seized (Lovelace, 2025). Previously, thousands of counterfeit Ozempic 1 milligram injections had been seized by the FDA from warehouses outside of Novo Nordisk’s authorized supply chain in 2023 (Reuters, 2023). Additionally, a group of patients in Australia were harmed by fake Ozempic. The patients experienced hypoglycemia and seizures, indicating the counterfeit injections contained insulin instead of Ozempic’s semaglutide (Burger & Murray 2023). The adverse effects could have been deadly. The counterfeit injection pens had been obtained online. The European Medicines Agency (EMA) confirmed that none of the fake Ozempic had reached retail pharmacies.

Counterfeit Drugs on the Rise Globally
Photo Source: Statista

The cost of prescription medication remains a trending topic in the news cycle as well as a financial concern for many Americans. Legislation, such as parts of the Inflation Reduction Act, in addition to pharmacy benefit manager (PBM) operations, currently places pharmacies, especially independent ones, under financial strain. This creates an environment for counterfeit drug manufacturers to find inroads to circulate fraudulent products in the legitimate supply chain. The pharmacy in the recent Gilead suit appears to be a willing participant in the fraud (Gilead vs. City Plus, 2025). Safdar adds, "if true, these allegations of dispensing counterfeit medications reveal a deep betrayal of patients and a violation of patient safety. American patients should never have to worry if they are receiving real medicine when dealing with licensed bricks and mortar pharmacies." However, given the growing sophistication of counterfeit drug production, in an attempt to stay financially sound, unknowing pharmacies could fall victim to improperly sourced products. Counterfeiters create false sourcing documentation in addition to fake products and packaging. 

The World Health Organization estimates the global counterfeit pharmaceutical market value to be between $75 billion and $200 billion (Izgi & Altunay, 2025). It is imperative for the United States to propagate policies that strengthen the drug supply chain and bolster pharmacy support. It is not hyperbole to say that counterfeit medications are a matter of life and death. They are both an international and a domestic issue, given that pharmaceuticals are global products. It would be beneficial for the Department of Justice to take an interest in the current Gilead Sciences complaint, as well as the broader issue of counterfeit pharmaceuticals.

[1] Burger, L., Murray, M. (2023, October 24). Suspected fake Ozempic puts several in hospital in Austria. Retrieved from https://www.reuters.com/world/europe/several-people-taken-hospital-austria-after-taking-suspected-fake-ozempic-2023-10-24/

[2] Gilead Sciences vs. City Plus Care Pharmacy. 2025, March 17). Case 1:25-cv-01469-RER-RML. Retrieved from https://www.safemedicines.org/wp-content/uploads/2019/09/Heal-the-World-Complaint-as-filed.pdf

[3] Izgi, G., Altunay, M. (2025, June 2). Counterfeit pharmaceuticals: innovative strategies for combatting global health threats. Retrieved from https://www.ibanet.org/counterfeit-pharmaceuticals-innovative-strategies 

[4] Lovelace, B. (2025, April14). FDA warns about fake Ozempic in U.S. supply chain. Retrieved from  https://www.nbcnews.com/health/health-news/fda-warns-fake-ozempic-us-supply-chain-rcna201184

[5] Reuters. (2023, December 22). US FDA warns about counterfeit versions of Novo's diabetes drug Ozempic. Retrieved fromhttps://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-about-counterfeit-versions-novos-diabetes-drug-ozempic-2023-12-21/

[6] Walker, J, Ramey, C. (2022, January 18). Drugmaker Gilead Alleges Counterfeiting Ring Sold Its HIV Drugs. Retrieved from https://www.wsj.com/health/pharma/drugmaker-gilead-alleges-counterfeiting-ring-sold-its-hiv-drugs-11642526471

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Thursday, February 2, 2023

Colorado's Negligence: Drug Importation Continues to Miss the Mark

By: Jen Laws, President & CEO, Community Access National Network (CANN) & Board Co-Chair, ADAP Advocacy Association

Since 2019, Colorado has been trying desperately to put together a plan to import medications from Canada, known as a Section 804 Importation Plan (SIP) when applying for approval from the U.S. Food and Drug Administration (FDA). In December 2022, Colorado submitted its plan to the FDA (Colorado, 2022), thus joining Florida in a misguided state importation effort. Right now for patients living in both states, only the FDA is positioned to protect them from an ill-advised public policy.

Pill with Canadian flag imprint with US $20 dollar bills in background
Photo Source: Yahoo! News Canada

For what it’s worth, Florida’s plan has not yet been approved as that state continues to go back and forth with the FDA over clarifying language. The process has dragged on so long that Florida sued the FDA to speed things up (Kansteiner, 2022). Regardless of anything else that may or may not happen in either Florida or Colorado (protip: lots of things are not going to happen), Governor Polis’ promise that Coloradans are going to begin enjoying the fruits of this labor “soon” is just not going to be a thing. But beyond process, there’s some serious problems with this idea of importing medications from Canada and the idea that it will save Americans any dollars at the pharmacy counter. Those problems have been around since the idea of importation was introduced a government “solution” nearly 20 years ago and the answers to these problems has not changed or improved.

Back when the United States started toying with importation as an idea, the Canadian government balked and even introduced legislation to block the possibility. While that legislative effort failed, it’s being revived now as Colorado and Florida push to have access to the drug supply of a country with one tenth the size of the population of the United States. Outside of Canadian legislation, distribution agreements in Canada generally curtail what can and cannot be exported to other countries, a regulatory and enforcement move that neither the United States nor Colorado can do anything about. Canada’s biggest concern remains rooted in the potential for medication shortages to meet the needs of their own population, especially given the global issue of supply shortages on critically necessary medications.

It's not just the government of Canada or even manufacturers that remain concerned about the whole host of issues importation brings. Both the Canadian Pharmacists Association and the American Pharmacists Association have repeatedly cautioned against these proposals (CPhA, APhA, 2022). Despite what Colorado says these efforts will do, helping pharmacies isn’t in the reality of this effort. Targeting contracting tricks pharmacy benefit managers use to push out competition, particularly ridiculously low reimbursement rates and narrowing of network pharmacies, would go much further toward protecting independent pharmacies and ensuring patient access to them.

American and Canadian pharmacist associations warn that drug importation policies could put patients at risk
Photo Source: CPhA, APhA

Moving to another issue, the idea of “savings” offered under Colorado’s SIP are not rooted in reality. The first and foremost issue with any politician pitching “savings” on medication costs comes down to exactly “who” is going to enjoy these savings. Proposals to date do not establish “loss ratio” parity in medical and prescription insurance benefits – the Affordable Care Act (ACA) capped profits for medical coverage at fifteen or twenty percent but no such similar rule applies to pharmacy benefits or more commonly known as prescription drug coverage. These plans for “savings” do not necessarily translate to lower cost medications at the pharmacy counter for patients but for lower costs for governments and government programs – which should already be enjoying if those pharmacy benefit managers (PBMs) were actually fulfilling their promise of extending cost savings to their clients. They’re not and, respectfully, that’s precisely the issue most Americans care about – “What am I going to pay?” And it’s the answer politicians very carefully avoid giving.

An additional problem with Colorado’s assessment of savings is the SIP explicitly cites retail medication costs, not the costs the state government actually pays (which is often steeply discounted or enjoys rebates that bring those list prices down considerably). The calculation Colorado cites, very blatantly, is a lie.

Next, of the one hundred twelve medications Colorado specifies as targets for importation, HIV treatments are one of the highest cost medications on the list. We’ll get to why that’s particularly problematic for people living with HIV…now.

Safety security in the supply chain from importation does not align with the United States’ effort to ensure quality medications are getting to patients. The United States employs something called “track and trace” which requires electronic monitoring and labeling specific to the United States from the manufacturer throughout the entire chain of handling medications until they land in a patient’s hands. Importation from Canada (or anywhere else for that matter) would necessarily disrupt this system of tracking by requiring relabeling and Colorado, in its SIP, is challenging the FDA’s requirement to disclose when a medication is imported and from where (pg. 44-45 of the SIP). Colorado notes that while it disagrees with the relabeling requirements (which include notation when a medication is being imported without a manufacturer’s agreement), the state says it will not import medication without those same manufacturers agreeing. Generally speaking, manufacturers aren’t going to agree to participate in this program. They’ve already said so.

The U.S. Food and Drug Administration (FDA) is the gold standard when it comes to reviewing and approving drugs. Medicines that enter the United States through importation will not be subject to these same strong standards and, as a result, counterfeit, substandard or diverted, repackaged and adulterated drugs could be introduced into our secure drug supply chain. Importation schemes could have life-threatening consequences.
Photo Source: PhRMA

Safety and fear of counterfeit is such a significant concern that Colorado has promised to have a third party periodically sample medications to ensure they’re authentic. And fake HIV medications have already been an issue in the United States. Part of that comes down to this exclusive reliance on private entities (namely manufacturer) to identify counterfeit medications. ADAP Advocacy Association’s CEO, Brandon Macsata, has already detailed his own, personal, potentially life-threatening experience with counterfeit antiretrovirals. And loose guardrails which muddy up securing medication safety aren’t going to make these issues any better – indeed, they’ll expose more People living with HIV to this risk.

Florida, as the other state pushing hard for importation, already knows this is a bad idea. It’s why their SIP explicitly makes the importation program medications an experiment – to be tested on the poor and imprisoned, touting to effort at addressing the state’s medications needs for Medicaid and prisons. Florida’s plan is, quite frankly, a moral and ethical disgrace. Colorado’s is rife with gimmicks.

It's high time states and the federal government appreciate that the United States, despite our issues, enjoys one of the safest medication supply chains in the world. Few if any of us stop to consider if the medications we pick up from our pharmacy are legitimate. Let’s stop with importation proposals that, in reality, won’t help patients afford medications and only threaten our supply safety, our diplomatic relationships, and patients lives. Bringing down end-user costs of medications absolutely requires government action, but that action isn’t going to be importation.

[1] Colorado (2022, December 5). Section 804 Importation Program - Colorado's Drug Importation Program. Retrieved from https://hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf

[2] Kansteiner, Fraiser (2022, August 31). In new lawsuit, Florida says FDA stalling on drug importation program. Fierce Pharma. Retrieved from https://www.fiercepharma.com/pharma/florida-tees-legal-showdown-fda-over-stalled-information-act-request-canada-drug-import-plan

[3] Panetta, Alexander (2022, December 8). Heads up, Canada: Colorado wants your drugs. CBC. Retrieved from https://www.cbc.ca/news/world/colorado-drug-imports-canada-1.6679290

[4] CPhA & APha(2022). American and Canadian pharmacist associations warn that drug importation policies could put patients at risk. Retrieved from https://aphanet.pharmacist.com/sites/default/files/audience/Joint%20Statement%20APhA%20and%20CPhA%20Importation%20.pdf

[5] Fein, Adam (2022, December 7). Drug Channels. Retrieved from https://twitter.com/DrugChannels/status/1600660225786318848?t=y1oWO_tiLVIuQIHrkOQmmw&s=19

[6] PhRMA (2023). Drug Importation. Retrieved from https://phrma.org/policy-issues/drug-importation 

[7] Partnership for Safe Medicines. (2022, September). Fake HIV Medication Reached U.S. Pharmacies—And Patients. Retrieved from https://www.safemedicines.org/2022/01/counterfeit-hiv-medications-in-the-u-s.html

[8] ADAP Blog (2020, November 19). How Drug Imports Can Endanger Patients. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/11/how-drug-imports-can-endanger-patients.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Thursday, February 27, 2020

A Secure Drug Supply Chain is the Best Anti-Counterfeiting Technology We Have

By: Shabbir J. Safdar, Executive Director, The Partnership for Safe Medicines

There are several technologies that have been developed to identify and weed out counterfeit medicines, from serialization to edible security tags on individual pills, but no anti-counterfeiting technology can take the place of a secure, and well-enforced medication supply chain.

Serialization, a central part of our Track & Trace system, provides unique identifying tags on individual packages of medication at the point of manufacture. It is an effective means of quickly spotting fake medicine. However, if you allow members into your supply chain that aren’t effectively regulated, or that are sloppy, it will not prevent patient harm. Though it will make it easier to find the problem after the fact in a follow up investigation by checking the serial numbers against numbers from the manufacturer.

One of PSM’s board members is fond of saying that no technology can protect you when someone is intent on trading your safety to make a dollar. Missing holograms can be ignored, serialized product can be mixed or repackaged with non-serialized product, and other means of making more money and endangering the patient. Serialization will always find the problem after the fact, but our safety goal is higher: we want to prevent such products from ever reaching patients in the first place.

Edible tags, such as the one’s being developed at Purdue University can make identifying genuine pills easier, but again, vigilance on the part of supply chain members is key to their success. A patient may be very interested indeed to find out if their prescribed medication is genuine but if their doctor does not bother to check, the security of edible tags is pointless.

Patients seldom see the packaging of injectable medications such as Avastin, used in cancer treatment; Prolia and Aclasta, used to treat osteoporosis; and Botox, used in treatments ranging from cosmetic to dental and ocular. Every one of these injectable treatments has been counterfeited and successfully sold in the United States, because no one bothered to the genuineness of the medication by examining the packages or checking lot and serial numbers or they had a financial incentive not to. In the case of counterfeit Avastin, U.S. authorities only discovered that American doctors were treating their patients with it when the United Kingdom’s MHRA alerted the FDA in 2012 to warn them that a fake version was in circulation.

If members of the secure supply chain do not carefully examine medication packaging and pills to verify that they genuine using anti-counterfeiting technology, drug counterfeiters can easily fool them with similar packaging and identical-looking pills and vials. The visual spotting of a fake by its label, box, or pill shape and color is imperfect, at best.

Real and counterfeit Alli pictures
Real and counterfeit Alli pictures

Lastly, there has been a lot of press about using blockchain technology to keep counterfeit drugs out of the supply chain. Manufacturers can use technological tracking of their products throughout the supply chain, but if any member of the supply chain ignores digital footprints for medication or fails to recognize their lack, blockchain falls apart and does nothing to protect patients. The best technology to protect patients from counterfeit medication is strong regulation, a secure supply chain, and clear consequences for manufacturers, wholesalers, distributors, and medical professionals who ignore or sidestep the supply chain. In every case where counterfeit medicine has reached patients, bad actors consciously breaking the supply chain put fake drugs in the hands of doctors, clinics, and pharmacies..

References:
  • Lilly Serialization: https://www.lilly.com/products/anti-counterfeiting/serialization
  • TC Medical: https://www.safemedicines.org/2015/05/canada-based-company-that-acted-as-drop-shipper-pays-33-million-fine-in-misbranded-drug-smuggling-case.html
  • Securing Industry edible tags: https://www.securingindustry.com/pharmaceuticals/purdue-scientists-detail-edible-security-tags-for-medicines/s40/a11237/#.XjryFC2ZO9
  • Black Market Cancer: https://www.safemedicines.org/2018/08/imported-black-market-cancer-meds.html
  • Black Market Osteoporosis: https://www.safemedicines.org/2013/01/the-us-food-and-drug-administrationfda-has-issued-warning-letters-to-20-us-doctors-that-they.html
  • Black Market Botox: https://www.safemedicines.org/2014/10/black-market-injectable-cosmetic-treatments-a-nationwide-problem-10-22-14.html
  • PSM Fake Avastin: https://www.safemedicines.org/2012/02/mhra-fda-cooperation-rousts-counterfeit-cancer-drugs.html
  • Reuters Blockchain: https://www.insurancejournal.com/news/national/2020/02/21/559057.htm
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, August 1, 2019

Trump Administration Pushes Bad Medicine with Drug Importation

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Our governing class has increasingly turned to politically expedient, so-called answers to the public policy issues facing our nation. Often they amount to nothing more then convenient sound bites for the cable news network's nightly programs. The high cost of prescription drugs is certainly no different, evidenced by the ongoing push toward drug importation as a remedy. Rhetoric aside the reality remains that drug importation is bad medicine, and it will do nothing to lower the cost of prescription drugs.[1]

Canadian flag with a hand holding prescription drugs
Photo Source: NADDI

Earlier this year, we highlighted the dangers associated with drug importation. Prescription drugs imported from our good neighbor to the north do not guarantee that they are safe, and even the Canadian government has acknowledged so. Whereas Canadian manufactured prescriptions drugs are pretty much as safe as the ones made in the United States, there is no guarantee the safety standards can be said for the ones brought into their national boundaries before crossing our border. The Canadian government - along with the Canadian healthcare industry - has also indicated that it cannot adequately supply safe medicines to the United States since many prescriptions drugs face shortages[2] in their healthcare system. These points are conveniently overlooked by the politicians of both parties pushing this bad medicine, as well as most news media reporting on drug importation.

POLITICO reported that in its misguided quest toward allowing drug importation the Trump Administration is considering two pathways. One option would authorize pilot projects thereby granting states, wholesalers or pharmacists the authority to import prescription drugs "consistent with FDA approval" from Canada on a limited basis.[3] The other option would allow drug manufacturers to offer lower prices for imported prescription drugs so long as the domestic and foreign drugs are the same.[4] In either case, it is much easier said than done.

The Canadian Pharmacists Association and the Canadian Medical Association (along with numerous other Canadian healthcare groups) strongly rebuked the proposals and urged the Canadian government to oppose it.[5] Public opinion polling among Canadians is also opposed to drug importation, since there already exist waiting lists to obtain many medicines. And the Canadian government is listening because Prime Minister Justin Trudeau has already promised to protect their nation's drug supply from flooding into the United States.[6]

The Trump Administration has once again demonstrated its "fly-by-the-seat-of-its-pants" style to governing and yet another troubling sign for people living with HIV/AIDS. The Partnership for Safe Medicines - of which our organization is member - characterized the proposals as "reckless and politically-motivated" with little hopes of achieving the intended outcome.[7] We agree!

Click to Watch PSM Ad Warning Against Dangers of Drug Importation



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[1] Acri née Lybecker, Kristina M.L. (2019, June 12). State Pharmaceutical Importation Programs: An Analysis of the Cost Effectiveness. SSRN. Retrieved online at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3402784.
[2] Shepherd MD (2010, Sept/Oct). The Effect Of US Pharmaceutical Drug Importation On The Canadian Pharmaceutical Supply. Can Pharm J. 143(5):226-33.
[3] Owermohle, Sarah (2019, July 31). Trump administration says it is studying 2 Canadian drug import pathways. POLITCO. Retrieved online at https://subscriber.politicopro.com/f/?id=0000016c-4803-d14f-ad7e-4a5786f50000.
[4] Owermohle, Sarah (2019, July 31). Trump administration says it is studying 2 Canadian drug import pathways. POLITCO. Retrieved online at https://subscriber.politicopro.com/f/?id=0000016c-4803-d14f-ad7e-4a5786f50000.
[5] Obiko, Natalie, and Simran Jagdev (2019, August 1). Trump’s ‘crazy’ drug import plan stirs backlash in Canada. Kennebec Journal. Retrieved online at https://www.centralmaine.com/2019/08/01/trumps-crazy-drug-import-plan-stirs-backlash-in-canada/.
[6] Kirkup, Kristy (2019, August 1). PM pledges access to medication as pharmacists, patient groups fear shortage. CBC. Retrieved online at https://www.cbc.ca/news/politics/drug-shortage-trudeau-justin-us-trump-1.5233591.
[7] Safdar, Shabbir (2019, August 1). Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Drug Importation Proposal. The Partnership for Safe Medicines.

Thursday, January 17, 2019

Safe Medicines in the United States aren't a Guarantee

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In 2019, prescriptions medicines in the United States are not immune from the increasing dangers associated with counterfeit drugs. In fact, it can be a serious issue. Dating back to the start of the HIV/AIDS epidemic in the United States, it is an issue that has also resulted in Black Market HIV/AIDS prescription medicines falling into the unknowing hands of HIV-positive consumers. Therefore, raising awareness about counterfeit drugs and the dangers associated with drug importation is an issue the ADAP Advocacy Association takes very seriously.

On January 31st, we are proud to sponsor a series of Congressional Briefings on counterfeit medications — which are being hosted by The Partnership for Safe Medicines ("PSM"). It is an issue that has impacted me, personally, and why I penned an Op-Ed in the Washington Blade last year on the inherent dangers (Drug importation policy is a hard pill to swallow).

I ordered medications from an online Canadian pharmacy. To this day, I have no way of knowing where the drugs were made or if they contained the active ingredients I needed to effectively treat my condition.

Counterfeit medications affect all patients: patients with acute diagnoses, patients with chronic conditions, and patients with immunodeficiency. A patient who has an acute bacterial infection needs a legitimate antibiotic with a proper dose to kill the bacteria and is endangered by the rebounding infection caused by a counterfeit that is beneath sufficient dosage. A patient with a chronic condition who needs maintenance medications may weaken and worsen if their maintenance meds are substandard in dosage. Patients with immunodeficiency may end up with serious additional infections if medications they take have not been sourced and stored in sterile conditions.

HIV patients may suffer all of these things at the hands of unscrupulous drug counterfeiters. Come to PSM's Congressional Briefings to hear the stories of counterfeit medicine victims, including an HIV patient, who received counterfeit drugs that impacted his health. Upcoming legislation proposals to bypass the U.S. Food and Drug Administration's safety protocols and import medicine from foreign sources that can neither be verified nor regulated will have profound affect upon all of the populations of patients who depend upon safe, accurate medicine to maintain their health.

HIV red ribbon next to spoon filled with Rx medicines
Photo Source: Community Access National Network

Black Market HIV/AIDS prescription drugs have been in the news for many years. In fact, several years ago PSM published an important report in collaboration with the Community Access National Network ("CANN"). The PSM-CANN report outlined numerous instances of counterfeit drugs in the HIV/AIDS drug supply change between 2006 and 2013. Download the report online.

Register today to attend either the free House breakfast event at 9 a.m., or the free Senate lunch event at 12 p.m., on January 31, 2019 in Washington, DC.