News from the FDA

Required Labeling about Antibiotic Resistance

A final rule outlining new labeling regulations, designed to help reduce the development of drug-resistant bacterial strains, is on display at the Federal Register. This final rule is aimed at reducing the inappropriate prescription of antibiotics to children and adults for common ailments such as ear infections and chronic coughs.

The new rule applies to all systemically absorbed human antibacterial drugs and requires statements in several places in the physician labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria. The rule also requires a statement in the labeling encouraging physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. This is part of ongoing efforts at FDA to encourage the development of new antimicrobials while preserving the usefulness of already existing ones.

An electronic version of the final rule can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1463-nfr00001.pdf.

More information about antibiotic resistance can also be found on FDA's website at www.fda.gov/oc/opacom/hottopics/anti_resist.html.

Improving the Development of Innovative Medical Products

The FDA announced on January 31 a broad initiative to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining FDA's standards of consumer protection. This is an FDA-wide initiative, involving all four of FDA's medical product review centers (drugs, biologics, devices, and veterinary medicine).

The FDA intends to achieve this goal through new actions in three major areas:

'Reducing the delays and avoidable product development costs by avoiding multiple cycles of FDA review when possible, through early communication and other steps to improve the quality of new product applications
'Improving the quality and efficiency of the review process, by adopting a quality systems approach to medical product reviews
'Facilitating new product development, by providing clearer up-to-date guidance for particular diseases and for emerging technologies.

To address the problem of marketing delays and increasing product development and review costs, the agency will begin by analyzing the root causes of product approvals that require more than one review cycle. Remedies to the problem include improving the quality and frequency of communications between the FDA and sponsors of drugs, biological products and medical devices, and implementing a continuous marketing application pilot project.

With respect to the second overall goal of this initiative, the FDA will establish a continuous improvement/quality systems approach to medical product reviews across the agency. This approach will include such initiatives as enhanced reviewer training on good review practices, institution of peer review within the the FDA review process, and further development of standards for the review process.

To achieve the third broad objective, the FDA will support the development of new technologies by creating clearer guidance for product approvals in priority areas. These published guidances will be designed both to help innovators develop new products and high-quality successful marketing applications for particular diseases, and to improve the FDA review process for emerging technologies.

In addition, the FDA believes it can help speed potentially important emerging technologies to the market by reducing regulatory uncertainty and increasing the predictability of product development. Toward this end, FDA will clarify the regulatory pathways ' pathways expected to cut across the FDA's product centers – in three emerging areas of technology: cell and gene therapy, pharmacogenomics and novel drug delivery systems. Additional information about these innovations, as well as FDA's report itself, can be found on FDA's website at http://www.fda.gov/. The full report is at: http://www.fda.gov/bbs/topics/NEWS/2003/beyond2002/report.html.

Collection of Race and Ethnicity Data

The FDA has published a draft Guidance for Industry to recommend categories for collecting effectiveness and safety data during clinical trials for ethnic and racial demographic groups.

FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. An analysis of modifications of dose or dosage intervals for specific groups is also required when manufacturers submit a new drug application for approval by FDA. To accomplish this, the FDA recommends that the drug manufacturers use the Office of Management and Budget (OMB) race and ethnicity categories during clinical trial data collection to ensure consistency in evaluating potential differences in drug response among racial and ethnic groups.
Although the regulations governing medical devices do not include requirements for the collection of demographic data comparable to those for drugs, for those cases in which race and ethnicity data are necessary to determine the safety and effectiveness of a device, FDA encourages sponsors to collect the data in accordance with the OMB information collection standards discussed in this guidance document. Sponsors are also encouraged to discuss any race or ethnicity issue with the appropriate review division within the Office of Device Evaluation, Center for Devices and Radiological Health, when developing their study protocols.
An FDA Talk Paper on
the subjects can be found at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01193.html.

Required Labeling about Antibiotic Resistance

A final rule outlining new labeling regulations, designed to help reduce the development of drug-resistant bacterial strains, is on display at the Federal Register. This final rule is aimed at reducing the inappropriate prescription of antibiotics to children and adults for common ailments such as ear infections and chronic coughs.

The new rule applies to all systemically absorbed human antibacterial drugs and requires statements in several places in the physician labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria. The rule also requires a statement in the labeling encouraging physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. This is part of ongoing efforts at FDA to encourage the development of new antimicrobials while preserving the usefulness of already existing ones.

An electronic version of the final rule can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1463-nfr00001.pdf.

More information about antibiotic resistance can also be found on FDA's website at www.fda.gov/oc/opacom/hottopics/anti_resist.html.

Improving the Development of Innovative Medical Products

The FDA announced on January 31 a broad initiative to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining FDA's standards of consumer protection. This is an FDA-wide initiative, involving all four of FDA's medical product review centers (drugs, biologics, devices, and veterinary medicine).

The FDA intends to achieve this goal through new actions in three major areas:

'Reducing the delays and avoidable product development costs by avoiding multiple cycles of FDA review when possible, through early communication and other steps to improve the quality of new product applications
'Improving the quality and efficiency of the review process, by adopting a quality systems approach to medical product reviews
'Facilitating new product development, by providing clearer up-to-date guidance for particular diseases and for emerging technologies.

To address the problem of marketing delays and increasing product development and review costs, the agency will begin by analyzing the root causes of product approvals that require more than one review cycle. Remedies to the problem include improving the quality and frequency of communications between the FDA and sponsors of drugs, biological products and medical devices, and implementing a continuous marketing application pilot project.

With respect to the second overall goal of this initiative, the FDA will establish a continuous improvement/quality systems approach to medical product reviews across the agency. This approach will include such initiatives as enhanced reviewer training on good review practices, institution of peer review within the the FDA review process, and further development of standards for the review process.

To achieve the third broad objective, the FDA will support the development of new technologies by creating clearer guidance for product approvals in priority areas. These published guidances will be designed both to help innovators develop new products and high-quality successful marketing applications for particular diseases, and to improve the FDA review process for emerging technologies.

In addition, the FDA believes it can help speed potentially important emerging technologies to the market by reducing regulatory uncertainty and increasing the predictability of product development. Toward this end, FDA will clarify the regulatory pathways ' pathways expected to cut across the FDA's product centers – in three emerging areas of technology: cell and gene therapy, pharmacogenomics and novel drug delivery systems. Additional information about these innovations, as well as FDA's report itself, can be found on FDA's website at http://www.fda.gov/. The full report is at: http://www.fda.gov/bbs/topics/NEWS/2003/beyond2002/report.html.