What is an authorized generic drug? — The People's Pharmacy


Q. I want to share my experience trying to purchase an “authorized generic” drug. Our doctor did not know what that phrase meant, nor did any of the pharmacists we talked to.

I found the label information for the authorized generic online and supplied that to CVS. CVS ordered the drug using the NDC code, but that was over a month ago, and it is still not in stock.

Walgreens could not find the NDC code in its computer. In the meantime, we had to go ahead and buy the brand-name drug at over $500 for a 30-day supply. Why is this so difficult?

A. When a brand-name medicine loses its patent, the original manufacturer sometimes strikes a deal with a generic drugmaker. That allows the generic company to sell the exact same formulation, made from the same “recipe.” Sometimes the authorized generic is made on the same production line as the brand-name drug.

As you discovered, most health professionals are unaware of this category. That may be in part because the generic drug industry, pharmacies and the Food and Drug Administration have promoted the idea that generic drugs in general are just as good as their brand-name equivalents.

You can learn about problems that have occurred with generic drugs and more details on authorized generics in our “Guide to Saving Money on Medicines.” This online resource is available at www.PeoplesPharmacy.com.

The NDC (National Drug Code) is a unique number to identify every drug sold in the U.S. The FDA maintains an online directory of all NDC identifiers.

Q. We are blanketed by television ads for new medicines. Many refer to increasing risks of contracting tuberculosis or advise against use if you have tuberculosis. What is common among these drugs that necessitates mention of TB?

A. The drugs you have seen advertised, such as Enbrel, Humira and Remicade, are immune system modulators. Doctors prescribe them to treat autoimmune conditions such as Crohn’s disease, inflammatory bowel disease, rheumatoid arthritis, psoriatic arthritis and psoriasis.

These medications (and others, such as Cimzia and Simponi) are effective in dialing down an overactive immune response in which the immune system is attacking body tissue. But we need the immune system to protect us against infection.

The pathogen that causes tuberculosis, Mycobacterium tuberculosis, can hide out in lung cells for decades without being detected. If the immune system is impaired, however, the germ can emerge and thrive, causing a debilitating, contagious and hard-to-treat infection that can be life-threatening.

TB is a leading cause of death for people with HIV/AIDS because their immune systems are not functioning properly. That is why it is such a concern for people taking medications that hamper the normal immune response.

Q. I have had terrible burning pains in my left foot and leg for many years. They were undiagnosed until a few years ago, when a new doctor diagnosed peripheral neuropathy. He prescribed daily Lyrica.

I do not take Lyrica every day, as it is too expensive. I take it only when I have an attack. The next day I am totally disorganized. I can’t remember things and have twitches all over my body. Could this be a side effect of the drug?

A. Yes. Side effects of pregabalin (Lyrica) include confusion, dizziness, sleepiness, difficulty walking, edema, blurred vision, dry mouth, constipation, twitching and tremor.

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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.”



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