With the 2016 U.S. presidential election in full swing, the candidates will surely continue to debate how best to rein in healthcare costs. Recent headlines, like those covering the huge price increases proposed by Turing Pharmaceuticals, have only ratcheted up the temperature in an already heated campaign season.
But what may be getting lost amid the election noise is the actions regulators, particularly the Food and Drug Administration (FDA), are already taking to help create cost savings through competition. The FDA's focus has been on the approval process of Abbreviated New Drug Applications (ANDA), which may allow generic drug companies to benefit from expedited drug approvals.
On Friday (3/11/16) the FDA's Office of Generic Drugs (OGD) announced a prioritization of the review of ANDA submissions. At the top of the list of priorities are potential first generic products, whose reference listed drugs do not have any blocking patents or exclusivities.1 Many view this as the FDA's response to Turing Pharmaceuticals, which proposed raising the current price of its drug Daraprim from $13.50 per pill to $750 per pill. Other companies may consequently think twice before pursuing price hikes of their own.
First Generics Seen as Public Health Priority
The FDA's action also comes less than two months after Dr. Janet Woodcock, Director at the FDA's Center for Drug Evaluation and Research, gave testimony to the Senate Committee on Health, Education, Labor and Pensions on the implementation of the Generic Drug User Fee Amendments of 2012. During her testimony, Dr. Woodcock cited the importance of "first generics," stating that "We consider 'first generics' to be public health priorities as they can lead to increased patient access." The announcement by the FDA officially transformed into an agency policy, the process of expediting first generic applications, which Dr. Woodcock compared to "an express lane at the supermarket."
Dr. Woodcock also cited some of the significant first generic approvals of 2015, including some drugs that are manufactured by companies held by Market Vectors® Generic Drugs ETF (NASDAQ:GNRX).
|Brand Name||Generic Name||Indication||Generic Company||% of GNRX
As of 3/16/16
1 Office of Generic Drugs MAPP 5240.3 Rev. 2
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