Skip to Accessibility Tools Skip to Content Skip to Footer
New Hepatitis Drug Process - Available at Pharmacies After FDA Approval.

New Hepatitis Drug Process – Available at Pharmacies After FDA Approval

How do I know a new drug is safe if it’s just been FDA approved?

The FDA approval process is not a quick experience for any drug or drug company. Although the public may not become aware of a drug until just before or just after it has received FDA approval, the drug has gone through a lengthy lifetime already.

Often, it can take scientists years or even decades of research before they believe they have created a drug that can treat or cure an illness. When the drug has been found or created, there is a lengthy process that involves many steps of clinical trials.

Initially, most drugs are tested on animals. This allows scientists and researchers to see side effects of the drugs more quickly than in humans without exposing humans to unknown drugs. For many, this is the end of a drug’s life as some drugs show side effects that are too brutal for any human to endure. They can range from hair loss to blindness, showing the researchers that this drug is not safe for humans, regardless of what it might treat.

If the drug passes the animal trial phase, it begins to be tested on humans who agree to provide detailed reports of the experience, as well as being observed by their doctors. Many drugs do not make it past this phase either, since side effects may only become present in humans. In addition to testing for side effects, the researchers are testing the drug against the illness and comparing whether it works as well as or better than drugs that already exist.

For probably obvious reasons, a drug company is not going to spend millions to market a product that is less effective than something already being sold, nor will they invest in a product that may be harmful to a large number of people if the research in clinical trials shows a high percentage of test subjects experiences some horrible side effect. This is why this stage of testing occurs for a long period of time and is completed more than once. No one wants to risk the health and safety of humans.

All of this takes place before the data can be submitted to the FDA for approval. In some cases, there is enough data or the demand for a quick treatment is strong enough that the FDA approves a drug quickly. Other times, the FDA can demand further testing before gaining their approval. This entire process from discovery/creation to FDA approval can take years, and every FDA approved drug has been studied significantly by many scientists, researchers, and independent parties in order to understand the drug as much as possible before it is approved by the United States FDA for patient consumption.

Does FDA approval mean I can get the drug immediately?

Sometimes. In some cases, the drug is readily available. This often happens when the drug is being created to treat an already existing problem that has no other drug treatment protocols.

Other times, the new drug takes time from FDA approval to reaching the shelves of your local pharmacist. This can be due to the need to manufacture large quantities of the drug after FDA approval, or because the company waits to see how many doctors are prescribing the drug. In addition, not all insurances will cover all newly approved drugs right away. Sometimes, insurance companies wait a number of months or years after a drug is available to the public to find out whether there are any long-term side effects before they will cover the costs of the drug.

Other times, insurance companies decide that another drug is less expensive to them while also being a fair treatment option, and thus, they see no need to cover newer and often more expensive drugs.

Whatever the situation, if your doctor prescribes you a newly approved medication, your doctor and pharmacist can guide you through the process of obtaining it or work with the confines of your insurance company to make sure you receive the best possible treatment for your needs and your wallet.

How do I know if a new drug that has been approved is better than the drug I am currently taking?

You won’t. If you are hearing about a new treatment option, speak with your doctor about it. Together, you and your doctor can decide whether a new drug will be better for you than something you are currently taking.

As is true with any changes to your drug regimen, never start a new drug or stop taking your current medication(s) without discussing it with your doctor. This will allow your ideas and concerns to be considered, as well as your doctor to share with you reasons why a new drug may or may not be the right fit for you.1-3

  1. "New Hepatitis C Drug Approved By FDA, Sovaldi (Sofosbuvir) By Gilead". N.p., 2013. Web. 19 Mar. 2016.
  2. "New Hepatitis C Drugs Coming In 2015". N.p., 2015. Web. 19 Mar. 2016.
  3. "What Is The Process For New Hepatitis Drugs To Become Available At Pharmacies After FDA Approval?". HEP. N.p., 2015. Web. 19 Mar. 2016.