Can Generic Drugs Be Trusted?
When faced with the decision to either purchase a brand name drug or save some money and buy the generic version, a consumer might be worried about the safety and efficacy of the low cost alternative. Due to stringent industry regulation, though, there needn’t be any greater concern about taking a generic drug than there is for a brand name one.
All drug products, whether name brand or generic, are regulated by Food and Drug Administration (FDA). FDA’s primary concern is with the safety of products intended for human consumption. This federal agency wields great power over pharmaceutical companies, including the ability to invoke a court injunction to force a company to stop manufacturing and distributing product if there is reasonable justification for doing so.
Companies which manufacture generic drugs are just as responsible to FDA as are the ones which produce name brand drugs. In the eyes of this particular federal agency, all products are viewed as equal. Generic drugs receive the exact same level of scrutiny.
Given that pharmaceutical companies do not want to draw the ire of FDA, the industry does a reasonable job of self-regulating itself. Obviously, the industry does not do a perfect job, but there are several measures used industry-wide to help ensure the safety of manufactured products. Companies which manufacture generic drugs follow the same steps and utilize the same systems.
One measure to ensure safe products is a system of extensive documentation. From the moment raw materials are received by a pharmaceutical company, all the way through the final stages of processing, every step taken is documented and usually checked by a second individual. So if one particular product requires the addition of twelve raw materials, the person adding each material will sign a batch record and a second operator will verify the ingredient and amount added, and then also sign. This system creates a tremendous amount of traceability and accountability.
Records used in the manufacture of both generic and brand name drugs are retained for years, usually beyond the expiration date of the actual product. At any time, FDA may come through to audit a company and request batch records for review.
In addition to the checks and double checks in place, pharmaceutical companies, even those which manufacture generic drugs, have extensive quality systems in place. Products are routinely tested at various stages of manufacture. The quality testing is typically conducted both on the physical characteristics (are tablets the right weight, are they the proper thickness, etc.) and chemical attributes. Quality labs will check for the active ingredient and ensure there isn’t either too much, or too little, and the product is safe.
With regard to drug products, when a company has an idea for a new pharmaceutical, they develop a formula and perform extensive testing before submitting their New Drug Application (NDA) to FDA. Once the federal agency has received the application, agents will begin investigating the product and determining whether or not they will approve the product. Now, the actual process itself is rather lengthy and in-depth, but this is what generally takes place for a new drug, which would be the name brand variety.
For a generic drug, the pharmaceutical company must wait until the initial patent expires for the brand name version. At this point, Research and Development teams will begin work. As soon as the company feels they are ready to produce a similar product, they will submit an Abbreviated New Drug Application (ANDA) to FDA for approval. An ANDA is not quite as extensive as an NDA, but it still requires ample investigation before FDA will approve the generic drug to be produced for human consumption.
Every generic drug goes through a series of checks by operators, has been tested by a quality control laboratory, and must have received FDA approval, so a consumer can feel as confident taking it as they would a brand name product.