Are Generic Drugs Safe?

Are Generic Drugs Safe

Generic treatments are getting more and more popular nowadays and it is because they present a cheaper option for the consumers. Although brand-name medicines are super effective for the medical conditions they were intended for, most consumers have trouble affording these brand name treatments due to their sky-high prices.

Since generic medicines are utterly cheaper than the brand name products at local pharmacies, buyers are conflicted about affording themselves these medicines or not. Price is a huge factor for the consumers, but they are also concerned about their safety whenever using generic medicines.

Are consumers safe whenever using generic drugs or are they better off choosing the branded medicines instead?

First of all, what are generic drugs?

Before exploring the advantages or disadvantages of using generic or brand name treatments, let us first define what a generic drug is.

A generic product is a copy of a brand name medicine and according to the United States Food and Drug Administration, these generic medications have the same indications, route of administration, onset, contraindications, drug interactions, dosage, side effects, and overall benefit as their brand name counterparts.

What this means is that brand and generic medicines are the same. Regardless of the outward differences of these medications, the function in patients of generic or brand name treatment should be the same and only vary slightly.

Also, according to the US FDA, generic medicines are deemed “generic” as long as they satisfy the following standards:

  • Active ingredient of the drug should be the same as the one found in the innovator drug (brand name drug) and generic companies should have proof that the active ingredient is indeed the same with the brand counterpart
  • The drug should be of the same kind (tablet and so on) and should have the same administration route in patients
  • Generic medicines should have the same indications and strength
  • They have “acceptable” inactive ingredients that should have no clinical significance when administered in the patients and companies should have proof that these inactive contents are indeed acceptable
  • Generic products should have the same duration in the body as the innovator product
  • Manufacturing of the generic medicines should be as rigorous as the brand name manufacturing and companies should be able to present proof that this is the case; FDA inspectors will visit the manufacturing sites and confirm if the data are accurate
  • Generic medicines should have the same label as the brand name products

However, generic manufacturers are not required to conduct their own animal or human studies for the dose, active ingredients, or inactive components of the medications.

Generic drug companies with ANDAs (abbreviated new drug applications) that satisfies the following parameters may be approved to market, as long as the patent exclusivities of the brand name medicines have legally ended.

Are brand-name medicines the same as their generic counterparts?

In terms of action in the patients, yes, generic medicines should have an identical function in the patients due to their similar active ingredients. According to the FDA, brand-name drugs and their generic counterparts have basically the same risks and benefits when used by the patients. However, the FDA also notes that the medicines may have trivial variations in terms of size, purity, strength, and other factors due to the manufacturing process. As per FDA’s standards, there is certain allowable variability between generic and brand name medicines for the aforementioned parameters, just like the allowable differences, FDA has granted the different brand name drug batches.

Also, even if the brand name and generic drugs are technically the same, some research findings suggest that some generic medicines vary slightly in terms of absorption, as some were absorbed slightly less and some slightly more

Also, even if the brand name and generic drugs are technically the same, some research findings suggest that some generic medicines vary slightly in terms of absorption, as some were absorbed slightly less and some slightly more. Again, the FDA sets allowable variability for generic medicines.

As for appearance, though, innovator drugs and their generic counterparts may look dissimilar. You can impute this to trademark laws—some brand medicines legally prohibit generic medicines to share the same physical attribute as them, such as flavor, color, or shape. These differences, though, should not affect the overall effectiveness of the medicines.

If generic medicines are just the same as their brand name counterparts, why are they cheaper than the brand name or innovator drugs?

Generic medicines are usually approved by the Food and Drug Administration after a certain period of brand-name marketing exclusivity and after a laborious evaluation by the FDA. Generic treatments are marketed after the period to ensure that the innovators can recoup their expenses related to pioneering the product in the market.

Generic drugs, unlike branded or innovator products, are not required to be tested in animal or human studies. Brand name medicines, on the one hand, are tried and tested by their creators to ensure that they are ready for human consumption. This long period of clinical trials, tests, marketing feasibility studies, and various other considerations make companies bleed money, hence them passing on the costs to the clients so they can at least gain their capital back.

Another factor affecting the cheap pricing for the generic medicines is the existence of competition. When multiple generic medicines are approved, each brand will strive to be the most economical choice for the buyers, hence the discounted pricing. Since this is the case, the FDA grants trademark and patent protections for brand/innovator drugs lasting for several years to help them regain their capital.

Takeaway

Yes—generic medicines are safe to use. Consumers may have doubts regarding the integrity of generic treatments, but these doubts should not mislead them—generic medicines, according to the FDA, are on par with their brand name counterparts, provided they pass the rigorous FDA examination. Approved generic drugs are absolutely safe to use and have the same effect as their brand name counterparts. However, it may take some time before generic counterparts of several brand-name medicines are introduced in the market to give the innovator drugs some room to recoup lost capital.

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