Studying Drug Regulatory Affairs? Here Are the Pros & Cons of Generic Drugs

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Many individuals associate name brands with quality, and will only substitute brands with cheaper generic equivalents if they can be convinced that doing so is not a downgrade. When it comes to medicine, the dilemma of whether to choose a generic or name brand can be especially difficult.

Generic drugs are typically less expensive than the name brands that they replace. However, medicine is not something that many people want to experiment with. If a generic drug doesn’t work as well, the difference could have serious repercussions on a person’s health.

Are you considering regulatory affairs training? Read on to learn a few facts about generic drugs.

Pro: Generic Drugs Really Are Cheaper and Are Often a Better Value

Drug development is generally a lengthy and expensive process that requires tons of research and clinical trials before a drug is even approved and can be sold on the market. Therefore, major drug companies making that initial investment will usually look to recoup their investment by branding the drug and keeping the price relatively high. According to the Science Media Centre of Canada (SMCC), it takes an estimated $1 billion to develop a new drug.

Companies receive a 20-year patent on drugs that they develop and brand. After this period is up, manufacturers of generic drugs are free to create their own version of a drug that uses the same active medicinal ingredient. The SMCC estimates that it takes just $3 to $10 million to develop a generic drug, and because there is so much less investment to recover, the makers of generic drugs can keep their prices much lower.

Because both drugs use the same active ingredients, buyers should normally get the same results from either option. For that reason, it’s arguable that generics offer better value for most people.

pharmaceutical regulatory affairs

Generic drugs are cheaper to make, and therefore cheaper to buy

Con: Students in Regulatory Affairs Training Shouldn’t Expect Generics to Be Totally Identical

Generic drugs are created to be “bioequivalent.” This means that taking them should result in a similar amount of the active ingredient entering the bloodstream at a similar concentration to that of the original drug. However, it’s important that students in regulatory affairs training realize that perfect bioequivalence is not required by law. A tolerance of 25 per cent exists, meaning a given drug can be a bit weaker or stronger.

While this often makes no difference, some individuals can have no reaction to weaker drugs, or too much of a reaction to stronger drugs. For this reason, it is ideal to try to make generics as close in effect to the original as possible. Your pharmaceutical regulatory affairs training program will help you explore generic drug development and the regulatory framework surrounding it, allowing you to take an active, informed role in creating the generics of the future. Create generics that match the originals closely, and you could help solve the issue of drugs working differently than expected.

Con: Students in Regulatory Affairs May Know That Other Ingredients Are Different in Generics

A drug is more than just its active ingredient. Mixed in are other substances that do things like dye the drug a particular colour, improve the ability of the active ingredient to do its job, and have other cosmetic, structural, and practical effects.

The inactive ingredients that are found in generic drugs can be completely different than those in the originals. On the one hand, this usually won’t matter because people buy drugs for the active ingredient. On the other hand, some individuals may be allergic to an inactive ingredient that is present in the generic, but wasn’t found in the original, which is not ideal. Sometimes it’s necessary to include allergens in a formulation for cost purposes. While it’s not ideal, as long as the drug is deemed safe after the development and regulation phases are over, it’s safe to be put on the market.

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Occasionally, patients might be allergic to a generic drug

Are you interested in careers in regulatory affairs?

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