When drugs are taken off the market because of concerns about their safety, it makes headlines.
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Most of the drugs that are taken off the market are removed for reasons other than safety.
However, sometimes drug makers choose to remove drugs from the market even if there is no problem with their safety profile. In fact, from 1994 through 2015, 215 drugs were withdrawn from sale, and only 5.1 percent of them were withdrawn for reasons of safety or effectiveness.
When manufacturers withdraw drugs from the market, that isn’t necessarily the end of the story. It is possible to reintroduce them. Until a few years ago, this could be done through a simple request to the FDA. However, more recently, the FDA has changed its policy for reviving discontinued drugs.
Why Do Companies Stop Making Certain Drugs?
A manufacturer that makes branded drugs may choose to discontinue a drug because generic drugs have been introduced and have essentially ended the branded drug’s market share. Sometimes a company removes a drug from the market because of ongoing drug patent litigation, or because the settlement of such litigation requires that they wait a certain number of years to market the drug.
Why Do Companies Choose to Reintroduce Drugs to the Market?
After a drug has been effectively mothballed, it isn’t removed from the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the so-called Orange Book). Drugs that have been removed are annotated with the symbol “@” next to the name in the Orange Book.
A discontinued drug may be remarketed, for example, when ownership of the New Drug Application (NDA) or Annotated NDA has been purchased by another company that is interested in reintroducing the drug. If a new use is found for a discontinued drug, the manufacturer may choose to remarket it.
With the cost to develop a new drug often exceeding $1 billion, more companies are developing research programs to uncover new uses for existing drugs – of which there are many thousands. Manufacturers are finding that this is a relatively inexpensive way to increase flow in the pharmaceutical pipeline.
Repurposing old drugs is far less expensive than developing new drugs from scratch.
The FDA’s New Process for Reintroduction of Discontinued Drugs
Today, when a drug manufacturer decides to reintroduce a discontinued drug to the market, it takes more than a phone call to the FDA. First, the manufacturer must notify the FDA that it wants to remarket a dormant drug. Before approving or denying the request, the FDA will ask several key questions about the drug, such as:
- When was the drug originally launched?
- When was the drug removed from the market?
- When was the last time the drug was manufactured?
- Will the drug use the same supplier of the active pharmaceutical ingredient (API)?
- Will the same manufacturer make the reintroduced drug?
- Will the same process and equipment be used to make the drug?
Manufacturers are asked to submit requests for remarketing drugs at least two months before the planned relaunch so the FDA has time to process the request.
Repurposing old drugs for rare diseases is a form of pharmaceutical innovation that is gaining importance, due to the extremely high cost of developing new drugs. Repurposed therapies can, in fact, be transformative, as was the case with monoclonal antibodies, which went from being a cancer treatment to a treatment for multiple sclerosis. There’s every reason to believe that discontinued drugs will continue to find new purposes as well.
With artificial intelligence being used for text mining of scientific literature, researchers may be able to infer connections between drugs and conditions that have never been tested before. It could allow old drugs to be used to treat different diseases without the huge price tag involved in creating new drugs from scratch. Reintroduction of discontinued drugs could prove to be an effective way to help more people and provide lucrative additions to pharmaceutical companies’ product portfolios.
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