Laying the Foundation

Whenever a new FDA commissioner is named, the pharmaceutical industry wonders how drug regulation will change. The big question is, Will the pendulum swing toward increased scrutiny of safety concerns, or toward faster approvals? The current commissioner, however, is being asked to address a more prosaic issue first, relating to the everyday management of the agency's work, particularly the people and resources involved.

Laura Bush

In recent years, a few lawmakers have loudly criticized the agency for failing to meet all its responsibilities. Now, in a new report, the General Accountability Office (GAO) has made a calm and comprehensive analysis, rightly pointing out the gaps in the agency's own knowledge of what it has, does, and needs.

In the report, the GAO said the FDA should develop a comprehensive assessment of the agency's staffing resources, particularly contractors; an assessment of the extent to which the agency is meeting its responsibilities; and an evidence-based estimate of the resources needed to fulfill its mission. Currently, the agency lacks data in many of these areas.

Given the scope of the agency's work, it is not surprising that the FDA cannot easily trace every dollar or every contractor hour worked. As the report succinctly captures, the agency's workload, and even its mission, keep getting larger. To wit:

• Since 1999, 11 laws have expressly expanded FDA's medical product oversight responsibilities. Other laws indirectly increase the agency's work.

• The number of drug, biologic, and device applications grew 30% from 1999 to 2008, and the number of products approved or cleared for marketing grew 55%.

• Adverse event reports increased 228% from 1999 to 2008.

• Companies requested 885 more meetings about drugs and biologics in development (an increase of 56%).

• The number of foreign establishments registered to produce medical products increased by 1,921 (up 23%).

• Meanwhile, rapid advances in science and technology have increased the complexity of the medical products submitted to FDA for approval.

Yet clearly, it makes sense for any organization to have a good handle on how well it is fulfilling its mission, and how it is getting it done. If the FDA does not know where the gaps lie, it cannot ensure that it is using its resources well, or even make accurate budget requests.

In its response to the report, the FDA agreed to gather the information requested. The Pink Sheet also reported recently that FDA Commissioner Margaret Hamburg has proposed an agency reorganization that includes creating a new office of budget. "I intend to make the development and presentation of the agency's funding needs and performance goals among my highest personal priorities," she is quoted as saying.

People often disagree about whether the best way to regulate drugs is to put greater emphasis on safety, on the one hand, or on speed, on the other (to get new treatments to patients faster). But perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively. A key step to doing that is to accurately assess how, and how well, the work is getting done.

By carrying out the analysis the GAO has requested, the FDA will set a solid foundation for addressing its gaps, defending its funding needs, and then tackling the issues before it. Because certainly, the FDA has plenty of work on its hands.

Laura Bush is the editor in chief of BioPharm International, lbush@advanstar.com