Generic drugs account for more than 90% of prescriptions filled in the United States. The Food and Drug Administration insists that they “have the same high quality, strength, purity and stability as brand-name drugs.”
What are the advantages of using generic drugs? The main selling point is financial. The FDA estimates that Americans have saved $3 trillion since 2016 by buying generic rather than brand-name drugs.
A reader recently asked: “Does the FDA require a generic drug to be an exact copy of a brand-name drug, or does the drug get approval if it is just ‘similar’? I’m not asking about quality control in manufacturing, but about original FDA approval.
“I recently read that generic drugs can be FDA approved if they are just close to the brand-name drug. Most of us believe we’re getting the exact formulation at a lower cost. Are we being duped?”
This seemingly simple question actually has a complicated answer. Way back in the 20th century, the People’s Pharmacy often advised readers to request generic drugs whenever they could. We believed that the FDA’s approval process ensured equivalence at great savings.
Over the last two decades, however, we have discovered serious flaws in the system. For one thing, neither the FDA nor brand-name manufacturers make it easy for generic drug companies to duplicate popular medicines.
Let’s start with the original brand-name formulation. The pharmaceutical company has told the FDA about the principal ingredient or API (active pharmaceutical ingredient). But it does not have to share the way in which it makes the medicine. So-called inactive ingredients (excipients) hold the API in a pill or other format and contribute to its release in the body. That “recipe” is a trade secret.
As a result, generic drug companies must reverse-engineer their versions of the medication. That means the copycats are not exact duplicates of the original pharmaceutical. The generic company has to start from scratch and try to match the brand name both in the way it is made and the way the active ingredients are released. The result is rarely an “identical” version.
The pitfalls of this process became especially clear to us in the case of a generic medicine called Budeprion XL 300. It was a copycat of a brand-name antidepressant called Wellbutrin XL 300.
Soon after the generic was approved in 2006, readers of this column began reporting unpleasant symptoms and reduced effectiveness. We alerted the FDA, but it took years for the agency to investigate. Eventually, it agreed that Budeprion XL 300 and some other generic forms of bupropion were not comparable to the brand-name product.
The FDA rarely, if ever, releases the data it uses to approve a generic medication. As a result, physicians, pharmacists, hospitals, insurance companies and the public never get to see the actual data the FDA uses to approve a generic copycat. Nobody but the FDA knows how closely a generic drug mimics an original brand-name medicine.
A recent analysis by independent investigators found that dissolution of bupropion can still be a problem. The formulation of a drug used to prevent organ rejection, tacrolimus, may also pose difficulties. If this medicine does not work properly, a transplanted organ could fail.
Many health care professionals believe that generic drug quality is a minor technical issue. In fact, it can be a question of life or death.
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In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of King Features, 628 Virginia Drive, Orlando, FL 32803, or email them via their website: www.PeoplesPharmacy.com. Their newest book is “Top Screwups Doctors Make and How to Avoid Them.”