2005N-0410 Prescription Drug User Fee Act (PDUFA): Public Meeting
FDA Comment Number : EC5
Submitter : Mr. Robert Spiller Date & Time: 12/07/2005 06:12:45
Organization : Mr. Robert Spiller
Category : Individual Consumer
Issue Areas/Comments
These comments are addressed to PDUFA, but could be applied to any regulated product user fee program. [paragraph]

PDUFA III has clearly accelerated product approvals, but it has not proportionately added to the resources necessary to police the enlarged field of sponsors and products thus approved. Future PDUFAs should set equally firm performance standards for detecting and enforcing against the rare violators and the rare defective, unsafe or ineffective products that will be the inevitable result of more approvals. [paragraph]

The five-year plan for PDUFA III seems to have kept ORA budget amounts flat, and allocated zero PDUFA funds to post-approval risk management by ORA. Any plan that generates extra funding for review and approval functions, but that does not at least proportionately provide for necessary increased resources for surveillance and enforcement of those products will ultimately result in impaired regulatory control of the (now-expanded) regulated product and regulated sponsor base. Any future PDUFA should establish some measure of product and sponsor compliance with the laws FDA enforces, and some measure of to what extent and to what effect FDA's enforcement resources are succeeding at requiring compliance with the laws FDA is obliged to enforce. [paragraph]

Of course, 'compliance' is harder to measure than counting days or approvals. But the agency could begin by crude measures of compliance: How many approved products necessitate withdrawal or more restrictive labeling? How many deaths per 1,000,000 uses of an approved product? How many approved products per 1,000,000 distributed required Class I recall? How many adverse events are later discovered to have been un-reported as required? How many material untrue statements per 100 applications? What percentage of product labels that are carefully reviewed turn out to be misbranding labeling? What proportion of advertised products are lacking a required approval or license? [paragraph]

For each measure of compliance, the agency might score itself by how it directed enforcement action at each category of non-compliance, and whether the year-to-year trend for each category was responding to enforcement action. [paragraph]

It is fair to both the consuming public (that suffers from the violations and mistakes) and to the industry that benefits from the increased flow of approvals, to require application of PDUFA funds to the product regulation necessitated by the laws FDA enforces. [paragraph]

FDA is not only an accelerant to progress in products, it is a regulatory agency, assigned by law to enforce the requirements of the law to those products, and to the people and organizations that make and sell them to the public. Any failure to ramp up FDA's compliance and enforcement resources to match increased regulated products and firms will ultimately result in damage to the public, reduced trust of the regulated industry and reduced sales of regulated products, so the law-complying regulated industry should be more than willing to support this necessary element of any future PDUFA. [paragraph]

Thank you for protecting the public. Please design future PDUFAs to continue that protection.