GDUFA Implementation and
Kim Dettelbach (Senior Counsel, FDA’s Office of
Chief Counsel)
Dave Read (Acting Deputy Director, Office of
Generic Drug Policy, OGD/CDER)
September 18, 2012
What can FDA do? What can
Industry do?
There is little obvious connection between the text
of the GDUFA commitments and 505(j), i.e., that
part of Hatch-Waxman most relevant to generic
drugs. With one exception, the GDUFA
implementing statute did not change H-W in any
way.* And the GDUFA Commitment Letter really
only adds one new category of expedited ANDA
that arguably is related to H-W.
*The period to obtain TA without forfeiting 180-day exclusivity was extended to 40
months for ANDAs filed between 1/9/10 and 7/9/12.
The Commitment Letter
Pursuant to the CL, FDA has three obligations regarding review
prioritization that touch on Hatch-Waxman:
#1: Expedite year 1 + 2 FTF PIV ANDAs.
#2: Expedite all FTF PIV ANDAs within 30 months of submission to
avoid forfeiture.
• The above obligations overlap and are familiar. Prior to GDUFA, OGD
worked hard to make sure FTFs don’t “slip through the cracks.”
#3: Expedite at submission and over the course of review ANDAs that
are/become eligible for approval as a result of no blocking
exclusivities, patents and/or applicable stays.
• The italicized portion is new. It usually concerns a subsequent applicant
that becomes eligible for approval based on a change with respect to the
What can FDA do? What can
Industry do?
Areas for Discussion
• Forfeitures of 180-day exclusivity
• Premature Paragraph IV notifications and similar
• FDA’s use of dockets for Hatch-Waxman issues
• When to bring in the Office of Chief Counsel;
and when not to
Forfeitures of 180-day
Exclusivity (6 events)
• Failure to obtain a tentative approval within 30
• Failure to market within a specified time after
• Expiration of all patents with which exclusivity is
• Withdrawal of the ANDA
• Amendment of all paragraph IV certifications
• Entering into an agreement that is in violation of
antitrust laws as determined by FTC
Forfeiture (cont.)
 Agency has no influence with respect to 5 of these 6
 Failure to obtain TA within 30 months is the forfeiture
event of prime concern to industry. The Agency is very
aware of its role in getting ANDAs tentatively approved
and is taking steps to minimize forfeitures on this basis
 GDUFA Commitment Letter goals are about actions,
not approvals and tentative approvals. However, the
CL does state that: “FDA will strive to review and act
on all ANDAs that are submitted on the first day that
any valid Paragraph IV application for the drug in
question is submitted within 30 months of submission
to avoid causing first applicants to inadvertently forfeit
180-day exclusivity eligibility…”
Forfeiture (cont.)
Our Mutual Goal – the Agency, like industry, wants as few “failure
to obtain TA” forfeitures as possible
The Agency is doing its part by adding review resources and
expertise at every level to ensure applications are taken up and
reviewed more quickly and complete responses (or approvals or
tentative approvals) are given on a 10 month clock
Industry must do its part by submitting higher quality applications,
taking advantage of Agency resources available for presubmission consultation when appropriate, and following advice
that FDA provides
We expect forfeitures under this prong to
decrease under GDUFA.
Even under the best of circumstances, occasional forfeitures are
DTR1 making forfeiture
Query: Is the current process for the agency
decisions satisfactory?
Slide 7
At this point I'll give a farly detailed description of the current process.
Some breif discussion of why this is a more complex question than it first appears.
Read, David T, 9/12/2014
Read, David T, 9/12/2014
Premature Paragraph IV notifications
and similar H-W practices
We understand that that the generics market is very competitive and
companies look for ways to make the system work for them; however,
certain “clever” strategies such as the following are counterproductive
and divert resources from review of applications – Premature paragraph IV notification (sent before the agency has sent a
letter officially acknowledging the ANDA as received)
• Contrary to both the statute and the regulations (despite strained
arguments to the contrary)
• A source of considerable confusion since notice kicks off time to
bring lawsuits; diverts review and other resources
– Abuse of NCE-1 process
– Untimely notification of litigation status; delay of notice until after
someone else’s suit has been resolved
– Untimely notification of launch triggering 180-day exclusivity.
FDA’s use of dockets for Deciding
Hatch-Waxman issues
• File 505(q) petition for issue falling within scope of
• For issues of general or widespread interest that we
discover or that are brought to our attention, we will
sometimes open a public docket
• Mixed message from industry
– We are sometimes asked to use this method more
– Others object to this process
• This process is public, transparent, and leads to wellconsidered decisions with input from interested parties
Slide 9
It is somehwta resource intensive, but has the significant benefit of creating both an opportunity for public comment and an AR of the
final decision.
Read, David T, 9/12/2014
When to bring in the Office of Chief
Counsel. . . and when not to
• On any given day, there are thousands of ANDAs
pending before the agency.
• It is therefore a “big ask” to request that OCC turns its
attention to one of these for more routine matters
• In general, you should not approach OCC unless there is
a significant legal issue or an issue that you believe has
been resolved incorrectly
• BUT if you believe we have made an error or are about
to make an error and/or are contemplating suit, we want
to hear from you
• If you do approach OCC, come prepared!