Limited Resources, Expanding Imports Challenge Regulators - Pharmaceutical Technology

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Limited Resources, Expanding Imports Challenge Regulators
The rise in overseas manufacturing undermines FDA oversight of drug quality.


Pharmaceutical Technology



Jill Wechsler
Twenty years of expanding assignments and declining budgets have changed the US Food and Drug Administration from the world's gold standard for drug regulation into a "debilitated, underperforming organization," according to the agency's advisory Science Board. In a scathing analysis issued in December 2007, the panel asserted that FDA suffers from "serious scientific deficiencies" and cannot meet its regulatory responsibilities, according to Gail Cassell, Eli Lilly vice-president and chair of the science board subcommittee that produced the report, "FDA Science and Mission at Risk."

The main culprit is inadequate funding. FDA lacks the staff and resources to support regulatory functions and to keep up with scientific discoveries important to understanding and ensuring the safety of medical products and the nation's food supply. Fast-expanding user fees have made up for some of the deficit, but increased reliance on industry payments has created inequities within the agency. An analysis by panel member and attorney Peter Barton Hutt reveals that budget increases during the last 20 years have been lost to inflation. FDA has gained only 700 appropriated staffers during this period, although its work was expanded by hundreds of statutes, executive orders, and other mandates.

A key FDA need is an information technology (IT) system able to process and integrate vast amounts of scientific information. FDA's IT budget generally totals about $200 million. This amount is much less than the $500 million that the Centers for Disease Control and Prevention (CDC) spends in this area, according to science panel member Dale Nordenberg, a former CDC IT official now with PriceWaterhouseCoopers. The report says that FDA probably requires another $200 million to be able to assess reams of clinical-trial data and track thousands of manufacturing sites around the world.

The many specifics in the report about how scientific research supports FDA assessment of clinical trials, manufacturing facilities, and product applications inspired Senate Health Committee Chairman Edward Kennedy (D-MA) to term the analysis a "wake-up call" to provide FDA with the resources needed to do its job. Rep. Henry Waxman (D-CA) called on FDA and administration leaders to tackle these problems.

Flat funding

Only a few days later, though, Congress approved long-delayed funding legislation for fiscal year 2008 (which began Oct. 1, 2007). The legislation boosted FDA's total budget funding to $2.2 billion—$1.7 billion without user fees. In light of heavy spending cuts across the federal government, FDA was fortunate to receive any budget increase at all. The extra funds are largely intended to expand food-safety programs. Agency advocates seek $2 billion in FDA appropriated funding in five years, and this year's budget takes only a small step toward achieving that goal.




The Center for Drug Evaluation and Research (CDER) has a $682.8-million total budget for 2008, almost half of it ($356 million) from user fees. The Center for Biologics Evaluation and Research (CBER) will have a $237-million total budget, with $81 million from user fees.

Although these may seem like large amounts, Congress uses the appropriation process to specify how FDA should spend the money and to micromanage agency policies. CBER is instructed to spend much of its added funds on pandemic influenza preparedness. Almost half of CDER's $40-million increase in appropriated funds is earmarked for drug safety, and much of that is directed to CDER's Office of Surveillance and Epidemiology. The Office of Generic Drugs gained $6 million more to boost its budget to $42 million.

Congress also provided an added $4 million to oversee direct-to-consumer (DTC) advertising instead of implementing a new user-fee program established by the FDA Amendments Act (FDAAA) of 2007. The user-fee program would have collected $6.5 million from manufacturers for timely DTC advertising reviews. The critical path initiative will receive $7.5 million—much less than the Senate initially proposed. Some of the money is earmarked for grants to universities and nonprofit organizations. For example, $563,000 will go to the Critical Path Institute and the University of Utah to support research about warfarin dosing.


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