Healthy Skepticism Library item: 15062

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

GAO: High-Risk Series: An Update
Pharma Live 2009 Jan 22
http://pharmalive.com/news/index.cfm?articleID=599731

Full text:

In January 2007, GAO detailed 27 high-risk areas and, in March 2008, added a 28th—planning for the 2010 Census. In the last 2 years, progress has been made in most of the 27 areas, although the extent varies. Overall, federal departments and agencies, as well as Congress, have shown a continuing commitment to addressing high-risk challenges, including taking steps to help correct several of the problems’ root causes.

In particular, the Office of Management and Budget has led an initiative to work with agencies to develop corrective action plans for high-risk areas. GAO has determined that sufficient progress has been made to remove the high-risk designation from one area: the Federal Aviation Administration’s (FAA) air traffic control modernization. Since 2007, FAA has continued to make progress in addressing the root causes of its past problems and has committed to sustaining this progress in the future.

Continued attention from the executive branch and Congress is needed to make additional progress in other areas. This year, GAO is designating three new high-risk areas. The first new area is modernizing the outdated U.S. Financial Regulatory System. As a result of significant market developments that, in recent decades, have outpaced a fragmented and outdated regulatory structure, significant reforms to the U.S. regulatory system are critically and urgently needed.

The current regulatory approach has significant weaknesses that if not addressed will continue to expose the U.S. financial system to serious risks. Determining how to create and implement a regulatory system that reflects new market realities is a key step to reducing the likelihood that our nation will experience another financial crisis similar to the current one. The second new area is protecting public health through enhanced oversight of medical products.

Concerns have been expressed about FDA’s ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and medical devices. GAO’s work examining a variety of issues at FDA echoes the conclusions reached by others that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.

The third new area is transforming EPA’s processes for assessing and controlling toxic chemicals. EPA does not have sufficient chemical assessment information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. Actions are needed to streamline and increase the transparency of the Integrated Risk Information System and to enhance EPA’s ability under the Toxic Substances Control Act to obtain health and safety information from the chemical industry.

The full report is available at http://www.gao.gov/new.items/d09271.pdf