We are always surprised when health professionals are unfamiliar with the concept of authorized generic drugs. We shouldn’t be. Medical and pharmacy students are not taught that there even are such things. For the most part health professionals are told that generic drugs are the same as brand name drugs. The FDA has promoted that message for years. That’s why most pharmacies purchase the least expensive generic drugs they can find rather than fill prescriptions with authorized generic drugs that are more expensive. After all, why spend more if the FDA says even the cheapest FDA-approved generic drugs are equal to brand name medicines?
Can Your Pharmacist Fill Prescriptions with Authorized Generic Drugs?
This reader wants to know why most pharmacists won’t fill prescriptions with authorized generic drugs:
Q. You have written about “authorized generic” drugs. I can’t find a pharmacy that will fill prescriptions with authorized generic drugs. Can you steer me in the right direction?
A. The makers of authorized generic drugs have negotiated agreements with the brand-name manufacturers so that they can use the exact same “recipe.” Sometimes authorized generic drugs are even made on the same production line as the original brand name medicine.
Reverse-Engineering Generic Drugs:
“Regular” generic drugs are often reverse engineered. That is to say the manufacturer tries to figure out how the brand name company created the original medicine. That information is considered proprietary.
In her best-selling book, Bottle of Lies, Katherine Eban describes the process of reverse-engineering:
“A brand-name drug, no matter how complex or difficult to make, inevitably follows a recipe, such as mix fifteen minutes, granulate, mist until ingredients reach 4 percent moisture content, mix again for thirty minutes. Making a generic version, however, requires figuring out a different recipe, ideally one that is faster to make but produces a similar result. That effort of reverse-engineering is undertaken by process chemists.”
Katherine goes on to describe Rajiv Malik, a process chemist who had worked at the Indian drug company, Ranbaxy. Rajiv was head of formulation development and regulatory affairs. He had mastered the art of reverse-engineering generic drugs based on the brand name formulation.
The book describes Rajiv’s effort to copy the brand name acne drug Accutane. Ranbaxy was planning to market it under the name Sotret. There was only one problem. As production ramped up, the generic drug wasn’t dissolving properly.
Katherine describes what happened next:
“Given the circumstances, the FDA’s regulations required Ranbaxy executives to withdraw the drug from the market and suspend making it until the failures could be remedied…
“The push for profits won out. They chose to continue the launch and conceal the problems from regulators, even as they returned to the laboratory in search of a solution.”
The Budeprion XL 300 Debacle:
Another example of reverse-engineering involved the antidepressant Wellbutrin XL 300. A generic manufacturer wanted to bring out a similar timed-release version. There was a patent on the membrane technology that allowed the active ingredient, bupropion, to be absorbed slowly into the body.
The generic manufacturer had to come up with a different release process. It chose a matrix formulation. The drug was not absorbed in a similar manner as the original brand name medicine.
We badgered the FDA for five years before the agency admitted that the generic Budeprion XL 300 was not “bioequivalent” to the brand name Wellbutrin XL 300. Here is a link to that sad saga in the FDA approval process.
Why Don’t Pharmacies Fill Prescriptions with Authorized Generic Drugs?
Once upon a time, independent pharmacists could decide which generic drugs they would stock. Some independent pharmacists still do that. But these days most chain pharmacies, big-box pharmacies, mail-order pharmacies and grocery pharmacies have central buying departments.
They may also use PBMs (pharmacy benefits managers). These organizations cut deals with generic drug companies. When you ask your local chain pharmacist to stock an authorized generic drug, the chances are good that she will look at you with dismay. That’s because she has little control over what generic drugs are placed on the pharmacy shelves.
Finding a list of authorized generic drugs can also be a challenge, and we don’t know of any list that is complete. However, you will find the best list we could assemble on our website at this link. You can also find it in our eGuide to Saving Money on Medicines. Look for it in the Health eGuides section of the website.
Not all medications have an authorized generic available. If you find the drug you are looking for, you will need to ask the pharmacist to order from that manufacturer specifically. Independent pharmacies may be more willing to do this than chains.