Are generic drugs safe?

What are generic drugs?

Generic drugs are medications which have been evaluated and approved by the Food and Drug Administration (FDA) of the United States as a genuine copy of brand-name (proprietary) drugs, in dosage, effects, safety, strength, how it is taken, quality, performance, intended use, and side-effects and complications.

Are generic drugs as safe?

Generic drugs use the same active ingredients and dosage, and have the same efficacy. They pose the same risks and provide the same benefits as their brand-name counterparts.

Do they take longer to work?

No, since generic drugs have the exact same composition as brand name drugs, they work as fast.

Are generic drugs as effective?

It is a requirement by the FDA for generic drugs to have the same quality, strength, purity, and stability as brand-name drugs, so they are as effective.

Are generic drugs inferior in quality?

No, generic drugs are not inferior to proprietary (branded) medications. The FDA makes sure the two versions of the drugs are equally effective and safe. Most healthcare providers themselves use generic medications for themselves and their family.

Why are generic drugs cheaper?

Generic drugs are less expensive because their manufacturers do not have to spend for research, development, marketing and promotions, which are very costly.  This large investment is made by the original, “new drug inventor and developer,” who patented the drug to have the exclusive and sole right to distribute and sell it.  When the patent expires, usually after 20 years, generic drug manufacturers apply to the FDA to manufacture and sell the generic version. When the generic version is approved, a greater competition comes into the market and this lowers the cost even more.

Presently, almost 50 percent of the prescription in the U.S. are filled with generic drugs. As always, the integrity and reputation of the manufacturer of generic drugs, anywhere in the world, will reflect the quality of the medications they produce.

How much cheaper are generic drugs?

Generic medications are typically lesser expensive than their branded counterparts, many about 85 percent less. Between 2007 to 2016, the United States health care system has saved $1.67 trillion. The more pharmaceutical companies come up with more generic versions, the greater the competition and the lower the cost of the generics drugs will be.

Do brand name companies make generic drugs?

Yes, about half of the proprietary (brand name) companies also produce generic drugs and sell them at the competitive price of generic drugs in the market. They can reduce the price at this time because they already made the profits with their exclusive rights during the patent period.

Why do generic drugs look different?

Trademark laws in the United States prohibit generic drugs to look exactly like their brand name counterparts. But the laws require the generic drugs to duplicate exactly the active ingredient and dosage in brand-name drugs. The flavor, color and some inactive ingredients may be different.

Do generic drugs expire sooner?

No, generic drugs do not expire sooner or have shorter shelf life. Basically, generic drugs are the same as proprietary medications.

Are generic drugs good for children?

Most of the generics drugs were tested among adults. There are generic drugs used for children, but more studies are being done to make sure generic drugs are as efficacious and safe for children, including infants. For any concern, the prudent option is to discuss the issue with your children’s pediatrician.

Do all brand name drugs have generic version?

No, not all proprietary drugs have generic equivalent. Many come only in the brand-name version. Part of the reason is the duration of the patent of these other brand-name drugs. As long as the patent is in effect, FDA will not allow any generic manufacturer to produce the generic version. But even after the patent has expired, the generic equivalent must also pass through the stringent testing, evaluation, and approval by the FDA to protect the consumers.

Why can’t all drugs start as generics?

The very prohibitive cost of research and development, marketing and promotion, makes it financially impossible for drug manufacturers to produce the original medications and sell them at the “generic price.” This is unrealistic to expect and economically not feasible.

How are generic drugs approved?

According to FDA rules: “Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA’s approval process.”

How does the FDA monitor generic drugs?

Here is the verbatim policy of the U.S.-FDA:  “The FDA Generic Drugs Program conducts a rigorous review to make sure generic medicines meet these requirements. In addition, FDA conducts 3,500 inspections of manufacturing plants a year, ensuring compliance with the agency’s regulations on good manufacturing practices. FDA staff also continually monitor drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (API) to products being sold to consumers, are safe, effective, and high quality. In the event of reports of negative patient side effects or other reactions, the FDA investigates and, when appropriate, may require changes in how a medicine (both brandnname and generic versions) is used or manufactured.”

Are generic drugs outside of the U.S. as good?

Each country’s version of the FDA would have their own rules, criteria and requirements, but basically I suspect they will be similar to those of the U.S. FDA’s. However, I am unable to ascertain this, and therefore cannot verify that generic drugs manufactured outside of the United States are as good. The Philippine Bureau of Food and Drugs (BFAD), in my opinion, is a credible institution that safeguards and protects the health and well-being of the people in our country.

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Philip S. Chua, MD, FACS, FPCS, Cardiac Surgeon Emeritus in Northwest Indiana and chairman of cardiac surgery from 1997 to 2010 at Cebu Doctors University Hospital, where he holds the title of Physician Emeritus in Surgery, is based in Las Vegas, Nevada. He is a Fellow of the American College of Surgeons, the Philippine College of Surgeons, and the Denton A. Cooley Cardiovascular Surgical Society. He is the chairman of the Filipino United Network – USA, a 501(c)(3) humanitarian foundation in the United States. Email: scalpelpen@gmail.com

Dr. Philip S. Chua
Dr. Philip S. Chua

Philip S. Chua, MD, FACS, FPCS, Cardiac Surgeon Emeritus in Northwest Indiana and chairman of cardiac surgery from 1997 to 2010 at Cebu Doctors University Hospital, where he holds the title of Physician Emeritus in Surgery, is based in Las Vegas, Nevada. He is a Fellow of the American College of Surgeons, the Philippine College of Surgeons, and the Denton A. Cooley Cardiovascular Surgical Society. He is the chairman of the Filipino United Network – USA, a 501(c)(3) humanitarian foundation in the United States.

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