Message in a Bottle

As we went to press, a memo written by John Jenkins, director of the Office of New Drugs (OND) at the US Food and Drug Administration, came over the transom. I think it speaks for itself. I will simply add, once again, that as we enter this presidential election season, we must demand that our aspiring presidents recognize that the "healthcare issue" involves more than just who will pay for consumers' use of prescription drugs, but also how we make and approve those drugs. Here, in its entirety, is Jenkins' memo:

"Over the past several years, the rate of growth in workload for OND has far outpaced our ability to increase our staffing. The workload growth has occurred in many areas, including the number of meetings conducted with sponsors, the number of requests for Special Protocol Assessments (SPA), work related to emerging safety issues and early communication, work related to responses to Congressional inquiries, etc. This workload imbalance was one of FDA's primary areas of focus when we were discussing with industry the PDUFA II and PDUFA IV program, and the PDUFA IV program includes a significant increase in resources to FDA to help address the workload concerns through increased staffing and better IT systems.

Michelle Hoffman

"More recently, we are faced with the increased workload related to the implementation of FDAAA (FDA Amendments Act) and FDA's Safety First/Safe Use initiative. In addition to the resource increases under PDUFA IV, FDA also saw increased appropriations for FY 2008 to help meet the growing workload. The new resources will have a significant impact on our workload-staffing balance in the long term, however, in the short term, CDER is approximately 550 FTEs below its ceiling for FY 2008.

"While we are working hard to recruit and train the necessary new staff (including replacement of staff who depart CDER for various reasons), it will take several years to achieve full staffing and to have all the new staff fully trained and productive. In that interim, it will be necessary for CDER and OND to make careful decisions about our work priorities, and those priorities will be reflective of our stated goals under Safety First/Safe Use to ensure proper balance between our focus on preapproval activities and postapproval safety issues.

"To that end, I have granted permission to OND division and office directors to make decisions to bring their unit's workload into better balance with their existing resources. These decisions will be made on a case-by-case basis since the balance is not the same in all divisions or even the same over time in any given division. We will still strive to meet our PDUFA goals whenever we can, however, in some cases we may not be able to meet PDUFA goals and managers have been given the discretion to make those decisions. We have actually failed to meet many PDUFA goals (e.g., goals related to meetings with sponsors) over the past few years, although we have generally been able to meet most of our application review goals. In the short term, our ability to meet PDUFA goals is expected to decrease. In some cases we may have to cut back on work by declining requests from sponsors for guidance (e.g., meetings, multiple cycle SPA reviews) and in other cases we may decide to go past the PDUFA goal date for review of an application. In cases where we decide to go past the PDUFA goal date the sponsor will be notified by the division management of that plan.

"It is important to note that decisions to miss the PDUFA goal date are separate and distinct from a decision to extend the PDUFA goal date by three months, which is allowed in response to the submission of a major amendment during the last three months of the review cycle.

"CDER faces significant challenges in hiring the 550 additional staff (plus replacements for staff who depart for various reasons) authorized in our budget for FY 2008. First, we have to find qualified candidates for the positions. We are aggressively undertaking that part of the effort through various channels including extensive advertisements and the use of recruitment incentives. Once we have identified a qualified candidate they must navigate through the complex Federal/HHS personnel system before they can receive an official job offer. We have worked to gain permission to streamline that process as much as possible, however, in many cases it can still take months for the paperwork to make its way through the system before an official job offer is made. In some cases, candidates choose to take other positions before an official job offer from FDA can be made.

"Finally, our pay structure often is not competitive to what qualified candidates can make in the private sector. We are working through existing authorities to make FDA's pay as competitive as possible.... As noted above, it is likely to take several years before CDER achieves full staffing and all the new employees are fully trained and productive. It can take 1–2 years, or more, for a new reviewer or project manager to be trained to do the complex work required at FDA. We will be continuously assessing our workload and resources over time and make decisions on our priorities. There is no specific end date since I cannot predict when our resources will be in balance with our work. That is why there is no blanket policy but rather permission to reduce work as needed on a case-by-case basis."

Send your ideas and comments to Editor-in-Chief Michelle Hoffman at mhoffman@advanstar.com