Comment Letter on Generic Drug User Fee

Docket No. : FDA-2012-N-0882-0002

Leslie Kux, Assistant Commissioner for Policy
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Generic Drug User Fee (GDUFA); Public Meeting; Request for Comments.

Dear Ms. Kux:

On behalf of the members of the Medical Imaging and Technology Alliance (MITA), we thank you for this opportunity to provide comments on FDA’s Generic Drug User Fee Act (GDUFA). We are pleased that FDA continues to seek input from industry during reauthorization of GDUFA. Promoting an efficient and appropriately funded review agency is in the best interest of the public health and the generic drug industry which supports and promotes public health.


MITA is the leading organization and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. The industry is extremely important to American healthcare and holds unique concerns marked by a continual drive for innovation and marketization cycles, complex technologies, and multifaceted supply chains—all with the goal of providing patients with safest, most advanced medical imaging currently available.

General Comments

MITA strongly encourages FDA to continue taking into account the special characteristics of positron emission tomography drugs and the unique processes required to produce and distribute these drugs during the development of the generic user fee program.

MITA supports GDUFA and the need to for user fees to provide the resources necessary to enable FDA to conduct timely reviews of generic applications. However, we must ask the Agency to consider the negative ramifications such a policy will have if applied without modification for commercial and academic producers of Positron Emission Tomography (PET) radiopharmaceutical drugs. These producers do not operate like conventional drug manufacturers. Due to the short radioactive half-lives (2 hours or less) of PET drugs they are produced by a geographically distributed group of ~150 academic and commercial sites, producing fewer than 100 drug doses per day per site.

PET Drug Distribution

PET drugs are produced by tagging substrate compounds with positron-emitting isotopes which are produced in cyclotrons. Because radioactive half-lives of PET drugs are less than two hours, the drugs must necessarily be administered to patients shortly after production. To accommodate these unique demands, PET drugs are produced on-demand in facilities within close proximity to the requesting medical facility. As such, these production facilities are geographically decentralized and divided into small scale operations, typically staffed with 2 to 8 individuals.

If a manufacturer is named as the applicant in an approved drug application (NDA or ANDA), they will necessarily require multiple manufacturing establishments across regions to account for the short half-live of PET drugs. The most common PET drug, fludeoxyglucose F 18, requires a manufacturer to operate 40 to 50 cyclotron facilities in order to provide a nationwide supply. An establishment user fee, when multiplied 40 or 50 times, would place unreasonable burden upon the manufacturers of these PET drugs, rendering multi-cyclotron PET production economically infeasible.

Continuing prior GDUFA Exemptions for PET drugs

Prior iterations of PDUFA and GDUFA have provided the following fee reductions and exemptions for PET drug manufacturers. MITA requests FDA continue these policies with the current negotiations:


  • Signed into law as part of FDASIA on July 9 2012, GDUFA currently provides PET human generic drug manufacturers an exemption from payment of all user fees. MITA urges FDA to continue this arrangement for GDUFA going forward.

Small Business Fees

  • MITA supports the adoption in GDUFA of an application fee waiver for small businesses submitting their first human drug application for review and who do not have another product approved under a human drug application.
  • MITA also requests specific inclusions in GDUFA for public health and barrier-to-innovation waivers. The limited financial resource of an applicant should be an important indicator of whether user fees are a barrier to innovation or whether a waiver or reduction is necessary to protect the public health.

As outlined above, we request FDA continue with its prior policies for considering the unique nature of PET drug manufacturing and distribution in developing this generic drug user fee program and respectfully urge FDA to utilize the previously defined fee structure and exemptions established for PET drugs under GDUFA.

* * *

MITA appreciates the enormous complexities associated with implementation of user fee guidelines. We thank you for considering these comments and recommendations, and MITA looks forward to actively engaging in continued dialog with FDA as the process proceeds.

Terri Wilson
Director, PET & Molecular Imaging

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