Regulatory Focus™ > News Articles > Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

Posted 06 February 2015 | By Alexander Gaffney, RAC

Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry.


As Focus has previously reported, FDA issued a Federal Register notice in August 2014 announcing that it planned to hold a meeting to discuss the implementation of the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA).

GDUFA, similar to other user fee programs, is meant to allow FDA to collect "user fees"—essentially fees levied on applications and inspections, much in the same way that the DMV charges you to renew your license or inspect your car. In return for those fees, FDA pledged to hire more staff to review generic drug applications, to make improvements to its regulatory review systems and to review applications under a more predictable timeframe.

Since the passage of GDUFA, FDA has released a handful of guidance documents meant to make the submission of generic drug applications, known as Abbreviated New Drug Applications (ANDAs), easier for companies:

A Call for Input

FDA, though, wanted to hear from industry regarding what other types of guidance it might issue to help the pharmaceutical industry.

Asked FDA:

  • "What other GDUFA implementation topics need the development of guidance?"
  • "Are there any topics or issues related to generic drug development other than those related to GDUFA implementation that need the development of guidance?"

The agency also said it would be assessing 180-day "first-to-file" exclusivity determinations, which permit generic drug companies to obtain 180 days of protection from other generic competitors if they are the first to successfully challenge a patented medicine.

FDA said it is considering making that process "public," allowing for more open consideration of whether an applicant might have forfeited their exclusivity rights. Under Section 505(j)(5)(D) of the Federal Food, Drug and Cosmetic Act, a 180-day exclusivity period may be forfeited if a company fails to market an approved drug within 75 days of approval, within 30 months of the date of application, or fails to obtain tentative approval, among other reasons.

More Time Granted

Now FDA is allowing companies an additional 30 days in which to comment on GDUFA-related policies and 180-day exclusivity.

In a notice posted to its website on 5 February 2015, FDA said it would still accept comments on the five draft guidance documents it has issued (see the list under the "background" section of this article) and 180-day exclusivity.

However, FDA said it is "no longer seeking comment" on another category contained in the original call for comments: First generic review prioritization. The agency is working on that issue separately.


Federal Register notice

FDA Website Posting


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