New Congress, New Challenges in the Year Ahead - Pharmaceutical Technology

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New Congress, New Challenges in the Year Ahead
Reauthorization of PDUFA will focus attention on drug safety, product pricing, and a host of regulatory issues.


Pharmaceutical Technology


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.

Ensuring quality

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 quality initiatives.

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 actions.

Curbing counterfeiters

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.

Going electronic

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.


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