Ask the Doctor: Are Generic Drug Products as Safe and Effective as Brand Name Drug Products?

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Answers provided by Gene Sullivan, MD, Emeritus Board Member of The LAM Foundation and former Deputy Director of the Division of Pulmonary and Allergy Products at the USFDA. Questions were created by The LAM Foundation by combining questions recently posed by patients with LAM.

Question:
My insurance requires that I use a generic form of sirolimus rather than the brand name drug, Rapamune. How do I know that generic form will work the same?

Answer:
Generic products undergo rigorous FDA analysis prior to approval. FDA requires generic drugs to have the same quality and performance as brand named drugs. Per the FDA website:

  • When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
  • Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.
  • The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
  • All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

Question:
I heard that there was a recall of the Dr. Reddy product earlier this year. How do I know if my medication has been recalled? Do I need to worry if I took some of them?

Answer:
The Dr. Reddy product was approved by the FDA as interchangeable with Rapamune before it was released as a generic alternative October 2014.

With regard to the July 2016 recall, any patient who was a part of the recall would have been contacted directly by their pharmacy. This recall only applied to certain lots of the product. See the below list of the lots and expiration dates. All affected lots were scheduled to expire on or before November, 2016.

The issue with the Dr. Reddy product involved detection of a trace amount of a breakdown product of sirolimus in the formulation, called secorarapamycin. A total of 9330 bottles of sirolimus were involved. The recall was classified as a Class III recall, which is used when the use of the product in question "is not likely to cause adverse health consequences.” Thus, the FDA ruling indicated that it is not likely that this minor impurity poses any risk to patients.

Question:
How do I know what is best for me – a generic or Rapamune?

Answer:
There are many factors that may affect your decisions related to taking a generic or brand drug product. These may include insurance coverage, drug availability, cost, and personal choice. Sometimes this choice can be made without your knowledge, for example when an insurance company changes the drugs on their formulary.

You are your own best advocate when it comes to managing your care and your providing feedback to your caregivers about your treatment plan. It is very important that you pay attention to your prescription labels and that you develop a good relationship with your pharmacist. Any changes to your prescription should be brought to the attention of both your pharmacist and your prescribing physician immediately. While it is unlikely that a change to or from a generic form of a drug will result in symptom changes, every patient has a unique response to drug therapy. Communication with your care team about how you are feeling is the best way to address your questions.

This recall only applied to certain lots of the product.

http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm

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  • Dblessed,

    I had an experience with two generics that I think needs to be posted. Generic drugs are required to have the same amount of active ingredients as brand and they are to have the same bioequivalence but that does not always play out exactly as it should. They may have different inactive ingredients and the manufacturing process of most medication are patent protected and not part of the original patent that was filed on the drug. The drugs delivery system may be a trade secret and not subject to the drugs patent. Generics manufactures do not get the "manufacturing process" handed to them at the end of a drug company's patent so some generic houses must do a kind of reverse engineering to figure out how to get the medication to work properly. This is a fact. I have worked in the pharmaceutical industry for substantial amount of time. Most generics are wonderful products at a cheaper rate and can be substituted for brand name products. However, the generic industry does not have to test their products on a full range and number of patients as do the drug company's that create them. They are test there availability on healthy subjects and they are not required to test on as many patients. That is why many doctors will prescribe only the brand name on thyroid medicine, warfarin or coumadin, heart rhythm drug, Quinidine and some seizure medications. I use generic medications on just about everything but two medications manufactured by generic houses have failed in me in the last year. A generic house had an issue in the making of Budeprion XL years ago because it dumped the active ingredient 4 times faster into the blood stream than it should have. Drug delivery systems are becoming more complex and there are still issues because the delivery systems of brand name drugs are often trade secrets under a different patent altogether which may not expire. And in my case last year, one medication I received in generic form worked but then the pharmacy switched to a different drug distributor who filled the medication from a different supplier, that suppliers medication did not worked. The other failure on my medication was from the first generic maker of a medication that's patent had just run out. All I am writing this for is that if you have a failure on a generic medication you may want to try a different generic manufacturer and if that does not work, try the brand.
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  • I would like to add to my previous post on generics. It is true that some generics are produced by the companies that once held the patent on them or are being produced by a subsidiary of the parent company and they produce them exactly the same with the same delivery systems. But, just because generics are required to have the same active ingredient, strength, dosage form, and route of administration (oral, sublingual, rectal) as the brand name product that does not mean stand alone generic houses have the same delivery systems as the brand manufacture. Wellbutrin is a prime example of a generic made poorly that past through the approval process but then dumped most of the active ingredient 4 times faster. As I said, since the late 1980's-90's drug companies continue to develop sophisticated deliver systems that are often protected as trade secrets that are not governed by the same patent laws. This determines how and when drugs release the active ingredients. Bioequivalence and pharmacokinetics (PK) are more than I want to go into in this post and you can look these up on the internet but anyone taking a generic should understand how this is determined and the % confidence interval (CI) that is used in determining whether the generic is given marketing access. The point I am making, since my last post I have failed 2 more generic drugs, totaling 4 in this last 3 years. Whether the delivery systems do not work well with my body or the drugs have been bought over seas I do not know. They were filled by a reputable pharmacy but I did call them to determine who manufactured them. All I am saying, is that if, if you feel the medication is not working as it should you can call your pharmacy to find out who the manufacture is. Go to the FDA website and file an FDA complaint! Then either try a different generic manufactured by a different generic house and if that fails call your doctor to switch you to brand name. Many pharmaceutical companies will provide the brand to lower income individuals if they are still making the brand and you meet there income threshold. You may have to file a formal appeal and have your doctor write a letter to your pharmacy administrator such as Express Scripts or Caremark or one of the others as I have done and you may need to get your HR health benefits administrator involved. I have had to do all of the above and once I received the new generic or brand everything has been fine.

    For the most part generics are wonderful alternatives. However, most doctors will still write brand for thyroid, seizure, warfarin and other medications I already mentioned that require consistent blood levels just because of these things. Pharmacy Times is a good online source and the FDA is as well, but you must understand the meaning of all the terms or you will think the FDA is saying everything is the same when it is not.

    "The FDA allows variance in the bioavailability between generic medications and brand-name products. Its rules ensure that a generic’s maximum concentration and area under the curve (AUC) does not fall more than 20% below or 25% above that of the brand name. These limits may seem exceedingly broad to many health care professionals. Still, the FDA has conducted more than 2000 studies on bioequivalence and determined that the average difference in AUC between the generic and the brand name was only 3.5%" (Pharmacy Times: What worries me about generics). This may be explained better in the article, "Debunking a Common Pharmacy Myth: The 80-125% Bioequivalence Rule".

    One other point I would like to address. Lymphangioleiomyomatoses is a complicated disease. Add to that, Polycystic Kidney Disease (PKD), with liver involvement (PLD), ME, and that is only the top 4 on a long list. This alone complicates any treatment protocol. Add to that generics that can have different inactive ingredients and this opens the door to a wide variety of difficulties. For people with complicated medical histories learn all you can about these things because you are your own best advocate. Add to this unscrupulous companies out to save a dollar and you end up with Valsartin that was being manufactured in China and Japan making it's way into this country's pharmacies which had a probable cancer causing active ingredients that resulted in a massive recall. Again, see the Pharmacy Times or the FDA's website. All I am trying to say is that generic's can be great. Almost 80% of prescriptions are filled with generics. Again see Pharmacy Times. So, yes there have been problems with generics so please research this for yourselves. Don't take anybodies word on this but your own. It is the safe thing to do.
    Reply
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