FDA could analyze public health consequences of its decisions better

A new report from the National Research Council lays out a framework for the U.S. Food and Drug Administration to systematically evaluate and compare the public health consequences of its decisions concerning a wide variety of products. Moreover, the risk-assessment framework provides a common internal language to discuss potential options and draws extensively on well-vetted risk literature to define the relevant health dimensions for FDA decision making.

FDA must make decisions daily, from determining whether a certain drug should be approved to deciding what resources should be allocated for inspections of food production facilities, the report says. The committee that wrote the report said the framework is intended to complement, rather than replace, other risk-based approaches at FDA and is designed to serve as a general guide while providing consistent risk information to support a variety of decisions.

The new framework, while easily articulated, would require FDA to invest thought and effort to implement properly. It consists of three steps: careful definition of the decision options, or characterization of the public of each option, and structured comparison of the consequences to inform and the public.

The committee applied the risk-characterization framework to four hypothetical case studies: deciding whether to withdraw a vaccine from the market, evaluating the potential public health consequences of foodborne illness, helping determine testing priorities for a laboratory, and choosing whether to improve existing surveillance of two . For each, the committee illustrated how its framework could be applied; defined the specific options to be compared; developed a risk-attribute table to characterize the public health consequences of alternative decisions; and illustrated how the risk characterizations could be used to compare the specific decision options.

The committee recognized that precise predictions of different consequences may be difficult to develop in cases where data are lacking or scientists are uncomfortable making the necessary judgments. However, decisions in which risk information could be valuable are made regularly. The committee recommended that FDA use experts who are trained in and comfortable with decision analysis, risk assessment, risk management, and specifically the assessment of uncertainties to facilitate the use of the framework.

add to favorites email to friend print save as pdf

Related Stories

Forest Service Web-based tool helps manage environmental risk

Sep 25, 2009

The U.S. Forest Service Eastern Forest Environmental Threat Assessment Center (EFETAC) recently launched the Comparative Risk Assessment Framework and Tools (CRAFT), a user-friendly, Web-based support system that helps natural ...

New warning OK'd for birth control patch

Jan 21, 2008

The U.S. Food and Drug Administration has approved a warning for the Ortho Evra Contraceptive Transdermal Patch label concerning the risk of blood clots.

FDA should adopt risk-based approach to food safety: report

Jun 08, 2010

The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal ...

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

Oct 24, 2014

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments