More oversight needed of unapproved medicines that threaten patients’ health

A recent boom in the marketing and sale of knockoff versions of new, innovative diabetes and anti-obesity medicines is raising serious patient safety concerns.

Vanity Fair recently published an investigation detailing the “wild west” of deceptive telehealth companies and compounding pharmacies who are flooding the market with these knockoffs with disastrous consequences it can have for patients.

Reuters reported that one security firm pulled down 250 websites for selling fake versions of diabetes and anti-obesity medicines. It is difficult to quantify the size of the market as it is not regulated with the same rigor as FDA-approved medicines, but according to Bloomberg the annual demand for compounded weight loss drugs could be more than a $1 billion.

How is this happening?

Rogue actors are taking advantage of a seeming regulatory gray area around drug shortages to make, market and sell lookalike products. In some instances, these entities falsely and dangerously are claiming their products are the same as the FDA-approved innovator medicines.

Importantly, compounded drugs are unapproved by the FDA and not only aren’t the same but are not subject to the same level of oversight. In fact, the FDA has made it clear that compounded products pose a higher risk to patients than FDA approved medicines “because they do not undergo FDA premarket review for safety, effectiveness, or quality.” 

The FDA has also provided updated safety information warning that compounded knockoffs often don’t contain the same active ingredients as the FDA-approved medicines.

The Vanity Fair investigation found this opaque industry has become a breeding ground for potentially illegal activity as, “a world of criminals and con artists are filling the void with life-threatening fakes.”

Patients are at risk.

Like the concerns we’ve raised about dangerous importation schemes, subverting FDA-approval standards, and opening our drug supply chain to counterfeit, substandard or diverted, repackaged and adulterated drugs has life-threatening consequences for patients. 

The FDA issued an alert to health care providers and patients about the risk of overdoses or dosing errors with the use of compounded knockoffs.

Late last year U.S. regulators seized batches of counterfeit and knockoff diabetes and anti-obesity medicines that had made it into the legitimate pharmaceutical supply chain.

The National Association of Boards of Pharmacy (NABP), an organization that works to help support patients and prescription drug safety, issued a report arguing bad actors are taking advantage of patients and putting them at risk.

To make matters worse, patients often don’t know they are being sold knockoff versions the brand diabetes and anti-obesity medicines.

Bloomberg recently interviewed a South Carolina mother who found a telehealth company that offered compounded versions of weight loss drugs. Her experience with the drug varied between doses – sometimes it worked, sometimes she had a negative reaction and in one instance the drug had no effect at all. What was most concerning was the inconsistency.

The Vanity Fair investigation found 352 adverse events reported to the FDA submitted by patients and providers. “Four people died, and many others suffered life-threatening reactions.”

The NABP report highlights other examples, including three Americans being hospitalized last year after using suspected counterfeits.

Moreover, the World Health Organization issued a new global warning last month, stating:

“These falsified products could have harmful effects to people’s health; if the products don’t have the necessary raw components, falsified medicines can lead to health complications resulting from unmanaged blood glucose levels or weight. In other cases, another undeclared active ingredient may be contained in the injection device, e.g., insulin, leading to an unpredictable range of health risks or complications.”

The companies that make the FDA-approved, innovative medicines are working to inform the public about the safety risks and to hold bad actors accountable.

Despite mounting evidence that this opaque market is putting patients' health and safety at risk, the compounding industry and rogue actors have largely been given a free pass. This issue desperately needs more oversight from lawmakers and regulators and bad actors need to be held accountable.