6.2: The committee recommends that the new Office of Drug Safety Policy and Communication should develop a cohesive risk communication plan that includes, at a minimum, a review of all center risk communication activities, evaluation and revision of communication tools for clarity and consistency, and priority-setting to ensure efficient use of resources.
The suite of recommendations put forward in this report—to improve the culture in CDER, attract and retain highly qualified staff, improve technological capacity, obtain and benefit from access to data and innovative scientific partnerships, and so on—are all dependent on adequate resources. An agency whose crucial mission is to protect and advance the public’s health should not have to go begging for resources to do its job. Also, the effect on CDER’s work of CDER’s overdependence on PDUFA funding with the strings that are attached hurts FDA’s credibility and may affect the agency’s effectiveness.
7.1: To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for the Food and Drug Administration.
The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report. This preference is based on the expectation that CDER will continue to review and approve drugs in a timely manner and that increasing attention to drug safety will not occur at the expense of efficacy reviews but rather it will complement efficacy review for a life-cycle approach to drugs. Congressional appropriations from general tax revenues are a mechanism by which the public can directly, fairly, and effectively invest in the FDA’s postmarket drug safety activities. However, if appropriations are not sufficient to fund these activities and user fees are required, Congress should greatly reduce current restrictions on how CDER uses PDUFA funds.
The year 2006 marks a major milestone in FDA’s history, public interest in drug safety matters has reached a high point, negotiations in advance of the September 2007 sunset of PDUFA have begun, Medicare part D has enrolled millions of senior citizens in a system that has the potential to yield useful data about experience with drugs, and congressional attention to drug safety issues has become intense. Now is the time to renew and transform