In an effort to make more medicine, more affordable, and arrest attempts at price gouging, the FDA has started taking steps to increase the number of generic prescription drugs on the market.
Off-brand or generic medications are much cheaper than the original name-brand drugs, despite having the same medicinal qualities. While these drugs are the biggest tool in fighting-off price gouging by pharmaceutical companies, recent high profile cases have shown a lack of competition and medicine shortages, have allowed several drug companies to dramatically increase their prices.
So the FDA decided to step in and implement a two-step plan. First it has posted a list of branded drugs that have no listed patents or exclusivities, for which the agency has yet to approve a generic drug application (known as an Abbreviated New Drug Application or ANDA). Then they implemented a new policy to help expedite the ANDA process for drugs on the list in order to get them to market as quickly and efficiently as possible.
The published list is intended to encourage development of new generics. Some of the drugs on the list include pain-killers, cancer medications, anesthetics, HIV medication, anti-inflammatories, and much more. There has been an issue with some of these drugs being in short supply due to quality problems shutting down manufacturing lines or companies simply abandoning the drugs to pursue higher margin medication. While the FDA doesn’t have the power to control the actual prices of medications, it does review and approve everything going to market.
One of the most well known extreme price hikes was when Turing Pharmaceuticals raised the price of an older drug, Diaprim, which was used to treat infections in patients with toxoplasmosis, often due to AIDS related complications. The price per pill was jacked up from $13.50 to $750, which is a factor of 56.
Another famous price hike was the increase for EpiPens.
“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require.” said FDA Commissioner, Dr. Scott Gottlieb in a statement.
He went on to say, “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
The FDA will now give priority reviews to new generic drugs until there are at least three on the market. It is around that point in which prices plummet, some up to 85 percent off the name-brand price.
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