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Generic Medicine Imports: What's The Impact?

What Are Generic Medicines? Generic medications are drugs produced to be similar to their brand-name medications. This similarity will consider the quality, performance, components, safety, strength, dosage form, and designated use. It helps establish bioequivalence, which implies that generic medications function similarly and provide the same clinical advantages as the brand-name types.

Therefore, generic medicine can be used as a substitute for its equivalent brand-name.



How are generic medicines different from brand-name drugs? Not only do generic medicines appear different in their colorings and flavorings, but they cost less than brand-name drugs. Generic medicines do not have to undergo repeated clinical human and animal trials to prove their effectiveness. Yes, they go through inspections, but not as many as the brand-names. This is precisely why generic medications are also referred to as "abbreviated new drug application." Also, various generic medicine companies are frequently being approved for marketing a single product. This approval would then fuel competition in the market and usually result in lower prices.

What Do the Reduction Costs Mean? Even though generic medications have similar characteristics and benefits as their equivalent brand-names, they are sold at a substantial reduction, estimating about eighty to eighty-five percent less. According to an IMS Health Institute report, generic drugs had saved the United States healthcare system $1.67 trillion between 2007 and 2016. Current Status on Proposals According to Human Services Secretary Alex Azar, The United States Food and Drug Administration in 2019 was proposing plans to enable prescription, generic medicine imports from Canada. The administration also intends to establish a more straightforward drug manufacturer process to import its FDA-approved medications manufactured overseas and placed on other nations' markets. "This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drug makers new flexibility to reduce list prices," Azar told HealthDay journalists. These proposals, according to Azar, will be "historic." Why would the United States Food and Drug Administration choose Canada? One analysis showed that Canada's generic medications are about 28% of the United States' cost. In contrast, another study of the 200 top-selling single-source brand-name medications discovered that Canada's generic drugs are 35% of those in the United States. Therefore, drug prices in Canada are lower than those in the United States. This is mainly because of the Canadian Patented Medicine Prices Review Board in 1987 managed the pricing of brand-name and generic medications not to be too high. Current Legal Status of Import of Generics The United States generic medicine market suffers from a severe lack of competition. With the increase of evergreening and biosimilars, entry barriers are only getting higher when it comes to the drug industry.

This problem is made even worse by possible collusion and market manipulation by drug companies. It is complicated to distinguish between two companies colluding and a company merely trying to mimic its competitors without extensive investigation. And competition matters. A study from the FDA found that drug prices drop 55% with two competitors, 33% more with 5, and another 13% with 15 competitors. Even worse, the lack of generics producers in the market has lead to severe drug shortages in markets lacking competition. “The prevalence of drug shortages for FDA-approved drugs, vaccines, and biologics has been as high as 12 percent in recent years, and most have involved markets that had been served by three or fewer producers.” (Bollyky). Impact of Import Deregulation The solution is simple. The FDA currently stringently regulates imports of drugs into the United States deregulation of drug importations would massively increase the number of producers in the market. Market competition will drive the market to equilibrium, keeping prices low, and preventing supply shortages. It’s time that we stand up to crony capitalism and big pharma. This is a non-partisan issue and a win for both sides of the political spectrum.



Democrats have made healthcare a top point and are calling for massive reform to fix our unaffordable healthcare system. Republicans have criticized government overreach and espoused deregulation for decades; Now is their chance to deliver free choice for consumers.

Amid the coronavirus pandemic, we have seen our country grow more and more divided and unproductive over the issues that matter most to Americans today. Let’s make sure this doesn’t become one of them.

By Michelle Diaz and William Liaw



Works Cited:


Thompson, Dennis. “FDA to Allow States to Import Prescription Drugs From Other Countries.”

WebMD, WebMD, 18 Dec. 2019,

-from-other-countries.

Center for Drug Evaluation and Research. “Generic Drugs: Questions & Answers.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers.

Newman, Tricia, et al. “10 FAQs on Prescription Drug Importation.” KFF, 19 Mar. 2020, www.kff.org/medicare/issue-brief/10-faqs-on-prescription-drug-importation/.

imshealth.com. Quintiles IMS Institute: Reports. Available from: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports

Rowland, Christopher. “Investigation of Generic 'Cartel' Expands to 300 Drugs.” The Washington Post, WP Company, 10 Dec. 2018,

www.washingtonpost.com/business/economy/investigation-of-generic-cartel-expands-to-300-drugs/2018/ 12/09/fb900e80-f708-11e8-863c-9e2f864d47e7_story.html?noredirect=on.

Center for Drug Evaluation and Research. “December 2019.” U.S. Food and Drug Administration, FDA, 2019,

Bollyky, Thomas J. “Can Drug Importation Address High Generic Drug Prices.” Hutchins Center Working Paper , May 2017.

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