According to a recent study, nearly three in four Americans are overweight. Worse, this report predicts that for decades to come, an increasing percentage of people in this country will be overweight or obese.
So, it’s not surprising that a relatively new class of weight-loss drugs, like Wegovy, is popular. While these medications are effective, they’re also expensive — around $1,000 per month. Because government and private insurers are pulling back on coverage of these medications, it’s creating a situation where only wealthier Americans can afford these treatments.
You’ve probably seen advertisements for discounted versions of these weight-loss drugs. Overnight, companies selling these discount medications surged onto the market due to a loophole in federal law that allows the sale of generic or “compounded” versions of these drugs during a national shortage of the medication.
Earlier this year, the nationwide shortage of these weight-loss drugs was resolved, and the Food and Drug Administration ordered the companies selling the compounded versions of these drugs to discontinue their sales. With so much money to be made by selling these knock-off drugs, these compounded treatments are still available. There’s another problem: the low-cost versions of these medications are not identical to their brand-name counterparts.
From the FDA’s website: “Compounded drugs are not FDA-approved … the agency does not review compounded drugs for safety, effectiveness or quality.”
A recent report from the Brookings Institution points out that most of these compounded weight-loss drugs come from China. Considering China’s well-earned reputation for cutting corners on quality and safety, this should be a concern for anyone taking a compounded weight-loss treatment.
The Brookings report also highlighted that the FDA allows manufacturers of these compounded weight-loss drugs to self-determine whether their product meets safety and effectiveness standards. This is not a sound system. The report urges Congress to address this situation to protect the American public.
Now, even though the FDA has declared the shortage over, many companies that sold these compounded weight-loss drugs have found a new loophole to keep marketing these products. This loophole allows these companies to sell medications that are “personalized” to the patient’s medical needs.
For example, companies are selling personalized compounded drugs that combine weight loss and erectile dysfunction treatments, but is this safe? No one can say because it’s all “personalized” compounded drugs sold through FDA loopholes.
Being overweight or obese can mean a person is much more susceptible to debilitating long-term conditions like diabetes, heart disease and stroke.
Don’t we owe these Americans an assurance that compounded weight-loss drugs are safe and effective? Companies selling personalized compounded drug treatments need to be better regulated, and Congress and the FDA need to address this matter before too many people get hurt.
Hank Naughton is the president of the Centrist Democrats of America