Standards
Generic medications must meet a certain level of standards to be put on the shelves or over the counter. The FDA requires drug companies to show that generic medications can be substituted for name brand medications. The FDA must show the generic medication version and name brand version to set the standard in the following ways.- Ingredients that are inactive in the generic medicine are acceptable.
- The active, important ingredient in the generic medicine is the same in the name brand medicine.
- The generic medicine is created under the same quality standards as the name brand medicine.
- The generic medicine has the same use indications, form (tablet, capsule, liquid or injection), same strength and route taken (oral, topical or injection).
- The generic medicine container is shipped and sold as needed and the label for the generic medicine is the same as the name brand.
- Establishing and maintaining scientific initiatives to research generic medications.
- Making educational materials and information available.
- Overseeing and managing the regulatory process to facilitate drug approvals.
- Publishing reports and data on the review and development of generic medications.
Approval Process
The FDA has an intense approval process for medications, generic or name brand. The FDA provides information to industry professionals to assist in the creation of generic medications. Approved generic medicines are sold after patents and exclusivities protecting the name brand medication version are at an end. Patents and exclusivities are in place to protect drug makers. The protection affects how and when a generic drug can be approved and sold to the public. New name brand medications are typically protected by patents, which are given by the U.S. Patent and Trademark Office. The U.S. Patent and Trademark Office prevents others from selling the generic version of the same medication. There are periods of marketing exclusivity for name brand medications only which impact the approval of generic mediations. The FDA is required to comply with any delays related to patents and exclusivities. When expiration of the patents and exclusivities expire, the generic medications can be approved and sold. The patents can be challenged by the drug company, and if the challenge is successful, the generic medications can be sold prior to the patent and exclusivity expiring.Pricing
In an effort to increase access to quality healthcare for more patients, generic medications are priced lower than name brand medications. Generic medications tend to cost less than the name brand medications because they are not required to conduct animal and clinical studies which are required of the name brand product and are conducted to ensure safety and effectiveness. Multiple applications are often approved to properly market a single medication product. This creates competition in the medication marketplace which results in lower prices for the public. However, consider the clinical trials are based on the formulation of the primary pharmaceutical company who owns the patent. Other formulations, such as are utilized by generic pharmaceuticals, have not been tested. The only requirement of generic drug companies is the active compounds be identical and dosages the same. Related Article: Prescription Savings Apps The pricing of generic medications is defined by the product having the same compound as the name brand. This excludes packaging and strength of the medication. Although generic medications have the same effect as name brand medications, they are sold at a lower cost because there is no research cost incurred by any studies. When multiple generic companies work to market an approved product, the competition in the market results in prices as low as 85 percent less than the name brand medication. The IMS Health Institute reported generic medications saved the United States healthcare system an astounding $1.67 trillion from 2007 to 2016.When to Avoid Generic Medications
As a patient, it is important to inform yourself on all aspects of generic medications. Many patients are skeptical that generic medications are as effective as name brand medications. Though generic medications are heavily regulated, there is still a chance a generic medication may not sync well with your body. It is possible to have an allergic reaction to fillers or ingredients in the generic medication, but not in the name brand medication. In some instances, the generic equivalent can cause rashes, skin discoloration or may contain an element in it that would contraindicate with other medications you may be taking. The FDA encourages patients to talk with their doctors, pharmacist, or other healthcare provider about generic medications, based on their own allergies. If you notice any worrying or new reaction after starting to take the generic medication, contact your doctor right away. Your doctor can identify the ingredient you are allergic to and provide you with a viable option. In many instances, patients may show a slow reaction over time, so even if the generic drug seems to be working well initially, practicing long term, ongoing vigilance is best. Related Article: Best Medicines to Buy GenericBy Admin –
