At the same time, Scott Gottlieb, then FDA deputy commissioner, gave a speech mapping out the agency's preferred approach
to improving drug safety. Gottlieb emphasized the need for better information about safety problems, more analytical tools
to evaluate safety signals, and improved FDA communication about potential safety problems. He encouraged tapping user fees
to provide more resources for drug-safety oversight but cautioned that over-reliance on risk-management plans could be burdensome
for health professionals who have to implement them.
Drug-safety problems often arise from inadequate quality control in manufacturing, a topic that FDA will continue to address
through its "Pharmaceutical CGMPs for the 21st Century" initiative. Since FDA concluded the initial phase of the project in
Sept. 2004, an internal Council on Pharmaceutical Quality has headed up agency efforts to adopt a more risk-based approach
to good manufacturing practices (GMP) inspections, manufacturing supplements, assessing chemistry, manufacturing, and controls
(CMC) data, and overseeing manufacturing quality systems.
FDA published a final guidance in Sept. 2006 describing ways manufacturers can establish quality systems for ensuring compliance
with GMPs. The guidance avoids imposing new requirements, emphasizing instead its voluntary approach to a more risk-based
quality-assurance process. This guidance eventually will be modified to reflect standards for quality drug manufacturing developed
by the International Conference on Harmonization (ICH). FDA supports this more global approach to promoting regulatory flexibility
based on demonstration of quality-control systems that mitigate risks associated with pharmaceutical development and production.
This and other initiatives will be discussed at a workshop in late February to review progress and to update industry on these
At the same time, FDA and other federal agencies are taking steps to enforce quality standards and compliance with FDA rules,
a topic that congressional panels will be revisiting in coming months. The US Department of Health and Human Services Office
of the Inspector General (OIG) is reviewing how well drug manufacturers take requested corrective actions following plant
inspections that uncover GMP deficiencies. And, the growing volume of drugs and medical devices from overseas has raised concerns
about whether FDA can ensure that foreign manufacturers observe its quality and compliance policies. The OIG plans to review
actions taken by FDA when it finds serious deficiencies at foreign plants to ensure that foreign firms comply with enforcement
Concerns that unsafe drugs could threaten public health are driving efforts to halt drug counterfeiting and protect the prescription-drug
supply chain. Several members of Congress back legislation to stiffen penalties for drug counterfeiters, and FDA is ramping
up investigations of these operators.
In addition, FDA seeks to implement its long-delayed rule that requires certain wholesalers to maintain pedigrees on the drugs
they distribute. The agency issued a guidance in November clarifying how the fairly complex tracking program should work.
Manufacturers and authorized distributors of record (ADRs) do not have to keep pedigrees, but FDA is encouraging all parties
in the supply chain to do so. Another FDA guidance explains that agency investigators will focus enforcement efforts on those
drugs most likely to be counterfeited such as very expensive, high-volume, and critical medicines. Small distributors, however,
claim that the pedigree requirement will force them out of business and have gone to court to block the program.
Meanwhile, FDA is continuing its campaign against drug counterfeiting. At a meeting on electronic track-and-trace technology,
FDA Commissioner Andrew von Eschenbach noted that any anticounterfeiting effort requires a multi-layer approach, including
initiatives to ensure product and packaging integrity, increased penalties for counterfeiters, and support from state officials,
in addition to pedigrees and tracking.
Von Eschenbach also discussed the need for more cooperation among drug regulatory agencies to battle fake drugs at a Nov.
2006 international summit in Washington. Directors of medical-products agencies from 20 countries attended the summit. And,
the World Health Organization has launched a new drive to halt the surge in drug counterfeiting, which is particularly rampant
in developing nations.
E-pedigree systems are just one example of how more-effective electronic information systems can address drug safety and other
regulatory challenges. FDA is pursuing a number of e-data initiatives to streamline the drug-approval process, better assess
adverse events, and make it easier for patients and health professionals to obtain current information on approved medicines.
A new Bioinformatics Board headed by deputy commissioner Janet Woodcock is overseeing the development of data and technology
standards to automate the communication of important information. One priority is to overhaul the agency's adverse-event reporting
system. The group also is establishing a standard computerized medical vocabulary and an electronic system for listing drug
products and manufacturing sites.