Senator: FDA’s Backlog of ANDAs is Causing “Harm” to Consumers

October 8, 2015

On September 28, 2015, Sen. David Vitter (R-LA) sent a letter to FDA’s Acting Commissioner, Stephen Ostroff, MD, in which he stated various concerns regarding an extensive backlog of Abbreviated New Drug Applications (ANDAs). Additionally, the Senator told the Agency that it needs to make reducing this backlog a top priority and “dedicate enough resources” to do so.

FDA currently has a backlog of more than 3,000 ANDAs that are awaiting approval. With 86% of prescriptions being filled as generics in the US, and with the recent increase in the price of generic drugs, Sen. Vitter says this poses a problem.

In his letter, the Senator claims that this backlog is not only detrimental to drug manufacturers, but more importantly, to consumers. Without the availability of these generic products, many consumers are allegedly forced to pay significantly higher drug prices. Vitter says this is unacceptable and “the bottom line is that this extensive backlog serves as a major obstacle to a market-based, competitive response to manufacturers who choose to run up prices.”

Vitter concludes the letter urging “that approval requests be fast tracked for generic drugs that may potentially provide immediate relief from high prices due to market manipulation or exploitation.

In response to this letter, FDA has announced that it is making some forward progress with its generic drug review program, and has approved more than 50 “first generic drugs”, the initial product introducing competition to the related brand name product. Additionally, FDA says that additional staff members have been hired.

Do you have a generic product on its way to approval? We can help with that. Using our novel approach, combining scientific knowledge with extensive regulatory expertise, we have a proven track record of helping our clients achieve successful interactions with FDA. To learn more about how we can help you, contact us today.

Generic Drugs Agency Alerts

January 4, 2016

FDA: Major Rule on Generic Drug Labeling Changes to Come in Summer 2016

In November 2013, the FDA introduced a proposed rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” Last month, the Agency announced the...

Read the Full Article
Generic Drugs Agency Alerts

August 29, 2016

FDA Issues Guidance Regarding the Agency’s Refuse to Receive Policy for Certain Abbreviated New Drug Applications

On Wednesday, August 24th FDA released a final guidance document, entitled “Abbreviated New Drug Application Submissions – Refuse to Receive for Lack of Justification of Impurity Limits,” which...

Read the Full Article
Agency Alerts General Regulatory

September 15, 2015

FDA Reviews First NDA for “Digital” Medicine Product

FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication...

Read the Full Article