What You Need to Know About Generics Drugs
Common Questions about Generic Drugs
Q: What are generic drugs?
A The term “generics” is used to describe prescription drugs that contain the same active medicinal ingredients and provide the same clinical benefit as the equivalent brand-name drug.
Q: Why should I take generic medications?
A Generic medications can save you a lot of money and still give you the same benefits as the branded version.
Q: What is the difference between branded and generic medications?
A Essentially just the name. When branded medications come onto the market, they have patent protection which means they have the right to be the sole source of that drug for a certain period of time. This allows the pharmaceutical company who invested a lot of money into developing the medications a chance to recuperate their investment. Once that patent expires, many drug manufacturers will start to produce the generic versions of that drug which contains the same ingredients.
Q: How do you know that the generic medications will work the same as the branded versions?
A The Food and Drug Administration (FDA) ensures that all generic medicine performs the same in the body as the branded versions. This means it must have the same dosage, form and route of administration, safety, effectiveness, strength and labeling. It also has to meet the same high standards for quality and manufacturing. If the generics can not meet these high standards, they are unable to be marketed and sold to consumers.
Q: If the generics are the same as the branded medications, why do they look different?
A Due to trademark laws in the United States, generic medications are not allowed to look the exact same as other drugs already on the market. Both the generic and branded medications share the same active ingredients but other characteristics like color may differ. These changes in appearance do not affect the performance, safety or effectiveness of the generic medication.
Q: Why do generic medications often cost less than the branded versions?
A When branded medications request approval from the FDA to be sold they must submit a lot of clinical study data on how their medication performs in both animals and humans. These studies need to show that the chemical molecule and active ingredients they want to sell are safe in humans. These studies cost a lot of money to perform and therefore to recoup some of that cost the branded medications are more expensive. For generic medications, as long as the chemical molecule of the drug and all the active ingredients are the same, they do not need to redo any of these clinical studies (the branded manufacturers already proved it is safe) and can go straight to market. The reduction in these upfront research costs means that generic medications are typically sold at a substantial discount, even though they have the same therapeutic effect as the branded version.
Q: How safe is a generic medication?
A Generic medications are as safe as the branded versions. Both must be manufactured according to the same Good Manufacturing Practice (GMP) requirements and will test the same critical quality parameters of the product (impurity levels, elemental impurities such as heavy metals, sterility testing). This rigorous testing is required regardless of where the product is manufactured.
Q: Are all branded medications made in the U.S.?
A No. Many branded medications are produced abroad in places like Europe, India and Asia. Just because the “owner” of the drug (eg. Pfizer) has a location or headquarters in the U.S. does not mean that the manufacturing facility is in the U.S. It is also not required to manufacture in the U.S., as long as the manufacturing facility can meet the standards of the FDA and produce quality medications that also meet the standards of the FDA, you can have a manufacturing facility anywhere.
Q: Why are lots of generic medications manufactured in India and China?
A Generic manufacturing is a booming industry in both India and China. There are now over 500 FDA-approved drug manufacturing facilities in China and India combined. So why are companies looking to China and India more often to produce medications? This has a lot to do with finding ways to reduce overhead costs. Simply put, drug manufacturers can product the same quality of product in India or China for less money. Luckily for you, this has nothing to do with quality of the product. Regardless of which country a medication is made, drug manufacturers are required to follow the same strict regulations set forth by the FDA. This means that all 500 facilities in India and China are required to follow the same struct manufacturing standards and regulations required by the FDA as any those in the U.S.
Q: How do you know if your medication is safe/FDA-approved?
AA If you are getting your medication from a licensed pharmacy than you are getting an FDA-approved medication. Licensed pharmacies are only able to sell FDA-approved products and it is illegal to sell prescription medications that are not FDA-approved.
Q: How does the pharmacy, patient and FDA know whether a product is counterfeit?
AA The FDA checks products that are imported into the US and products made within the US. They do this by frequently checking the serialization information on the product to ensure it’s safe. This requires a very comprehensive system that tracks the medication at every step through the supply chain process to ensure the medication was produced properly and to FDA standards. To avoid the possibility of buying a counterfeit medication, ensure you are buying your medication from a trusted source like a licensed pharmacy.
Q: How do I know if a pharmacy is licensed?
A Just because a pharmacy has “licensed” in its title does not always mean they are telling the truth. To ensure you are getting safe medications from a licensed pharmacy you can look up their licenses through your state board of pharmacy. Once you have located the licenses also ensure the pharmacy requires a valid prescription from your doctor, provides a physical address and telephone number in the United States and has a licensed pharmacist to answer any questions you may have. If you cannot confirm that the pharmacy is licensed in the US, you should NOT use that pharmacy.
Click to see all of Marley Drug’s 50 state pharmacy licenses. You can also access this information on your state board of pharmacy’s website.