Is There a Need to Test New Drugs On Animals? The FDA Modernization Act 2.0

From a murderous cough syrup to a blinding mascara, the importance of pre-testing drugs and other biological products is accepted despite the problems involving pre-testing on animals. Thankfully, a recently passed bill has resolved the issues involving animal testing…or has it?

Is There a Need to Test New Drugs On Animals? The FDA Modernization Act 2.0
Animal testing has remained shrouded in questions of ethics. Do recent advancements in technology have any answers?

The need to control and test drugs before humans consume them is a big part of modern medicine. People in the past have had to go through much trauma from using untested or poorly tested drugs and even cosmetics.

In 1933 Lash Lure, a cosmetic product meant to help darken and beautify women’s lashes ended up irritating and blinding some of its users. This unfortunate incident may have been prevented if the product had been pretested before use on humans.

Pre-clinical tests, as they are called, are tests that scientists carry out before humans can test or use substances. Currently, many large drug companies use animals in their preclinical tests as they are the most widespread and fully legal option.

However, there has always been strong opposition to how these tests on animals are carried out. Many modern scientists also believe there are better options than animal testing.

Some argue that animal testing is unethical and can’t give the best results even though it has been used for a long time. So, where do we really stand at the moment?

Do We Need Drug Tests?

It goes without saying that drugs are indispensable in today’s world. These mostly artificial substances help to improve people’s health and cure diseases. They are vital because they cause the desired effect, and no one wants drugs that don’t make us better or, at the very least, provide some relief.

However, there is also the need for these drug substances to be kept safe, controlled, and marked fit for human use. To that effect, countries usually have an agency or an organization that the government puts in charge of regulating drugs and other drug-like substances. The United States, for example, has the FDA which is responsible for ensuring the safety and efficacy of drugs and other biological products before humans use them. Before the FDA was established, the government created laws to prevent people from consuming harmful drugs and non-food substances. They also made rules that punished offenders if they broke these drug laws.

The first set of rules, the Food and Drug Act, was passed on the 30th of June 1906 and signed by President Theodore Roosevelt. This act made it illegal for the commercial trading of harmful or contaminated food, drugs, and drinks between states in the USA. It was, however, not enough to control the use of drugs, as many negative incidents happened even after the act became law.

One such occurrence was the 1912 case of  Mrs. Winslow’s Soothing Syrup, which was laced with morphine and ended up killing many infants. In another 1937 incident, an elixir Sulfanilamide containing diethyl glycol–a poisonous substance, led to over 100 deaths, many of whom were children.

FDCA of 1938

At this point, it was obvious that the Food and Drugs Act needed to undergo substantial change. And so, in 1938, the FDA passed an adequate bill into law–the Food, Drugs, and Cosmetic Act (FDCA). It added provisions for animal testing of drugs, proper branding, and even factory inspections.

This act, having undergone several amendments over the years, has helped stop the incidence of mass deaths from substance intake and has aided in enhancing the government’s ability to uphold the law.

Are Animal Tests the Answer?

Since the times of great Greek philosophers and scientists such as Aristotle and even the great Hippocrates, animals have helped foster advancements in science and medicine.

Animals have been used to test and validate specific claims on drugs and cosmetic substances as well as determine their safety before humans use them. The advantages of using animals as test subjects are numerous. Testing drugs on animals gives scientists comprehensive information on the expected results in humans. Mice, rats, dogs, monkeys, and apes are some of the most popular animals used for these tests. Biological similarities in some animals and their likeness with the human body systems make them good test subjects.

However, carrying out these tests and sourcing the needed animals is not as ethical as it should be. There are often cases of animal cruelty and the illegal trade or transportation of animals. And oftentimes, the drug’s cost and resulting efficiency might not be worth it as oftentimes, a drug goes through all the needed animal phases only to end up unfit for humans. It is on record that as much as 90% of drugs that pass animal tests fail when tried on humans. Hence, the need for alternative models for drug testing.

A Reform: The FDA Modernization Act 2.0

The first FDCA document of 1938 only had the option of animal tests as a method of drug testing, but there has been a recent change in that regard. The United States Senate has become one of the first to openly support the move from animal testing to other drug testing methods.

On the 29th of September 2022, the US Senate passed a unanimous vote in favor of an amendment bill proposed by senators Rand Paul (R-KY) and Cory Booker (D-NJ). The amended bill, now law, replaces a few phrases from the original 1938 FDCA document, which was in use for 85 years.

The new bill replaces the words “preclinical” and “animal” with a more flexible “non-clinical.” These little changes have a great impact and mean that scientists can use other methods besides animal testing to try new drugs. This is good news for animal lovers, as using animals as test subjects might soon become a thing of the past.

Whereas the former 1938 law only recognized animal testing as the prescribed method of testing new drugs, the new law opens the door for more non-animal testing methods.

What are some of these methods?

Alternative Testing: What Are Our Other Options?

The changes to the FDCA bill would be useless if there were no alternatives to animal testing drugs. One important factor to consider when testing drugs is how well the test subject can mimic the human body systems or cells.

While animal systems are similar, they aren’t exactly perfect and are sometimes time-consuming. However, ‌newer alternatives exist, such as the use of in-vitro methods and computer models, of which the latter can mimic specific organs or processes in the human body.

One groundbreaking invention in this regard is the organs on chips technology, a brainchild of Havard cell biologist Donald Ingber M.D., Ph.D., and his team. The technology mimics specific organs in the body and allows scientists to observe their drugs’ effect on these organs.

However, the downside to these alternatives is that their technology is not perfect yet. And, there is a need to be very specific regarding the human consumption of substances. Also, there is the issue of the rate of adoption or incorporation of these technologies into the already existing drug regulatory systems we have in place.  

Final Verdict

Senators Paul and Booker’s bill had numerous organizations pledge support even before being passed into law. Some notable mentions include; the CATO institute, the Center for Contemporary Science (CCS), and People for Ethical Treatment of Animals (PETA). Individual support from influential personalities like English primatologist Jane Goodall also set the tone of the act’s importance and helped bring attention to it.

The unanimous support that the bill has garnered is a pointer to the need for alternatives to animal testing in today’s world. However, there are still some concerns about the efficiency and reliability of new technology because these new models are not fully proven just yet. Making the change from an established system to novel models that makes many claims but has its own problems doesn't seem to be as easy as we’d thought.

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