Forbes has ranked the top 10 hottest products based on sales volume on Shopbop’s website in August 2018. One of the items on the list is Viagra — the generic version of the sex drug known better as sildenafil citrate. It’s been a year since Viagra became available generically, and while the drug did lead to a price drop, it didn’t lead to a price explosion. In fact, you can still find a decent-quality generic at a much more affordable price than the brand name version.

But getting an inexpensive generic version of a popular drug approved and available for purchase can still be a tricky process. As it turns out, there are a few different things that you need to do in order to make sure that your drug application gets accepted by regulatory agencies. Let’s take a look.

The Generic Drug Application Process

When a drug company finds a new chemical compound that could potentially be used to create a medication that increases blood flow to the penis (a phosphodiesterase type 5 inhibitor or PDE5 inhibitor for short), they have to complete a generic drug application (the “GDA”). The GDA is a form that needs to be submitted to the U.S. Food and Drug Administration (FDA) in the event that the company decides to go ahead and market a generic version of the drug. It’s a fairly straight-forward process, and most companies that are developing a drug for sale in the U.S. already have a GDA on file with the FDA. But while you’re waiting for the FDA to give you the go-ahead to market your drug, there are a few things that you need to keep in mind.

The first is that the FDA doesn’t always have to approve generic versions of drugs that already have been approved for sale in other countries. The agency will usually give its approval after reviewing the evidence that the drug will be safe and effective for its intended use. When developing a generic version of a well-known drug, the company has to prove to the FDA that the new medication is bioequivalent to the branded version — that is, it has to show that the new medication contains the same active ingredients as the branded version and have effects on the body that are essentially the same. This process can take several months.

A second thing that you need to keep in mind is that the FDA doesn’t normally approve new medications that are just a variation of already-existing medications. An exception to this rule is if the new medication has been shown to have superior bioavailability (the ability to be absorbed by the body to a greater extent) or less side effects than the branded medication. If a new drug doesn’t fit into this exception, then the FDA might not approve it. This is why it’s usually best when developing a new medication to seek additional research and evidence of the drug’s effectiveness in the real world. Never mind the fact that a medication that’s been shown in clinical trials to be significantly more effective might not be available for purchase due to drug company exclusivity contracts.

The Regulatory Hurdles Beyond The FDA

While the FDA is a major hurdle that you need to overcome in order to get your drug approved, it’s not the only one. There are several other regulatory bodies (including, but not limited to, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS), the European Medicines Agency (EMA), and the World Health Organization (WHO)) that you need to get permission from before you can begin selling your medication in their respective countries. And, in some cases, the approval process can be incredibly costly and time-consuming.

One of the things that you need to consider is that different countries have varying standards for the approval of generic medications. For example, in the U.S. it’s easier to obtain FDA approval for a new medication than it is in Europe. The reason for this discrepancy is that the EU doesn’t require generic medications to undergo the same rigorous testing that pharmaceutical companies need to have in order to get a new drug approved in the U.S. The standards for approval are different because the FDA considers drug applications to be “new drugs” as long as they’re not copies of already-existing medications. So while it may be easy for the FDA to approve a new medication, that doesn’t necessarily mean that it’s easy for you to market in Europe or Canada where the process can be considerably more burdensome.

The Price Of Good Research

One of the main reasons why getting a medication approved can be so difficult is that the drug companies have to foot the bill for much of the research that goes into the development of new medications. It costs a lot to do clinical research (where humans are involved), and the medications that are the subject of these studies typically have to be tested on humans before they’re approved. This process can take a long time, so if you want your drug to reach patients quickly then you may have to pay for it yourself. Or, at least, the price that you have to pay may be higher than what it would cost to develop and market the medication if it’s already been approved in other countries.

The fact that drug companies have to pay for much of the research means that they’re more likely to pursue medications for profitable uses. That in turn can lead to an over-abundance of medications that are designed to treat mental illnesses and behavioral deficiencies. While many feel that these medications can be useful, there’s also a risk that an over-reliance on such medications won’t do any good in the long run because we don’t yet know how much of these chemicals to introduce into the body.

The Political Stalemate

Getting a drug approved can be difficult because, as we’ve established, it normally requires you to go through several different agencies and organizations to get the final nod of approval. But it’s not just the regulatory process that’s to blame for the political stalemate that sometimes occurs when it comes to new medication approvals. Sometimes, the process can get bogged down in a political game of who-loves-who in the pharmaceutical industry and among healthcare providers.

There are a few occasions where a political argument has gotten in the way of a drug company obtaining approval for a new medication or where there’s been an outbreak of a new disease, and, in those cases, getting an approved medication can be significantly delayed. This is one of the reasons why it’s important to be patient and not to rush the process. At the end of the day, you’re trying to make sure that you help your sick patients, and the government needs to understand that you’re not a profit center but rather a healthcare provider trying to do what’s best for your community.

Forbes recently published a list of the ‘Hottest’ Products Based On Sales Volume On Shopbop’s Website In August 2018. One of the products on the list is Viagra. While the drug did lead to a price drop, it didn’t lead to a price explosion. In fact, you can still find a decent-quality generic at a much more affordable price than the brand name version.

But getting an inexpensive generic version of a popular drug approved and available for purchase can still be a tricky process. As it turns out, there are a few different things that you need to do in order to make sure that your drug application gets accepted by regulatory agencies. Let’s take a look.

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