Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

Agency: Department of Health and Human Services
Status: Open

Comments: In November 2019, FDA released for public comment its new Draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances. The draft guidance describes FDA's policy regarding the compounding of animal drugs from bulk drug substances including the conditions under which FDA does not intend to take enforcement action for violations of the Federal Food, Drug, and Cosmetic Act's requirements for approval, adequate directions for use, and current Good Manufacturing Practices. We will review the updated guidance when it is finalized and determine if it addresses this recommendation. In August 2020, FDA indicated that, in response to numerous requests from external stakeholders, the comment period on the draft guidance has been extended to October 2020. Once the comments have been reviewed, FDA anticipates finalizing the guidance by the end of calendar year 2021.

Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2019, FDA reported to GAO that when the Draft Guidance for Industry #256 was issued that calendar year, FDA intended to develop a risk-based compliance program to address compounding of animal drugs from bulk drug substances. As part of that compliance program, FDA reported that it intended to consistently document the basis for its decisions about what actions are taken, for example, warning letters, adverse event reports, and complaints. In August 2020, FDA reported that a working group has been formed to develop a risk-based compliance strategy, which will include a process for documenting the basis for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals. FDA anticipates implementing this strategy simultaneously with the finalization of Guidance for Industry #256, which is anticipated to occur at the end of calendar year 2021. We will follow-up with FDA regarding these actions and determine if the actions address our recommendation.

Recommendation: In order to improve the military services' ability to make facility investment decisions in accordance with DOD's strategic direction to include climate change adaptation considerations and additionally, to demonstrate an emphasis on proposing projects with an adaption component to installation planners, the Secretary of Defense should direct the Secretaries of the military departments to clarify instructions associated with the processes used to compare potential military construction projects for approval and funding so that, at a minimum, climate change adaptation is considered as a project component that may be needed to address potential climate change impacts on infrastructure.

Agency: Department of Defense
Status: Open

Comments: In May 2014, DOD concurred with our recommendation. Since then, DOD has made some limited progress toward integrating considerations of climate change into the processes of certain military services' military construction programs. For example, in 2016 briefing slides presented to congressional staff, the Army noted that two military construction projects were sited in a manner specifically designed to mitigate the impacts of climate change. However, as of March 2020, DOD had not provided us with evidence that the department's components have clarified instructions associated with the processes used to compare potential military construction projects for approval and funding. Thus, the recommendation remains open.

Recommendation: Congress should consider strengthening the current consumer privacy framework to reflect the effects of changes in technology and the marketplace--particularly in relation to consumer data used for marketing purposes--while also ensuring that any limitations on data collection and sharing do not unduly inhibit the economic and other benefits to industry and consumers that data sharing can accord. Among the issues that should be considered are: (1) the adequacy of consumers' ability to access, correct, and control their personal information in circumstances beyond those currently accorded under FCRA; (2) whether there should be additional controls on the types of personal or sensitive information that may or may not be collected and shared; (3) changes needed, if any, in the permitted sources and methods for data collection; and (4) privacy controls related to new technologies, such as web tracking and mobile devices.

Agency: Congress
Status: Open

Comments: As of July 2020, Congress has not taken action on this matter.