Tag Archives: gao

GAO: FDA designation doesn’t ensure safety

Ammonium Hydroxide and Phosphoric Acid, both GRAS. Photo by Benny BNut via Flickr.

On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.

The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”

Schneider’s version of the highlights of the GAO report:

  • The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
  • The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
  • Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
  • The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The GAO said nanomaterials and imported additives were of particular concern.

(Hat tip to OMB Watch in general and Matthew Madia in particular)

Is U.S. ready for Haiti-style mass casualty event?

The GAO’s latest release, “State Efforts to Plan for Medical Surge Could Benefit from Shared Guidance for Allocating Scarce Medical Resources (20-page PDF),” is the result of an evaluation of the nation’s medical capacity to deal with “mass casualty events,” a response they refer to as a “medical surge.” Read the one-page summary here. The release is a summary of a similarly titled 2008 report, but it has gained extra relevance in the light of the U.S. response to the similar circumstances of the 2010 Haiti earthquake.

The report found that states were making good progress in developing bed reporting systems and coordinating with military and veterans hospitals, as well as in selecting alternate care sites and registering medical volunteers. It also noticed that they were lagging when it came to planning for altered standards of care.


IoM: We need clear guidelines for disaster triage
What really happened at Memorial after Katrina?
AHCJ presentation: How prepared is your city for a health disaster? (Audio)
Protecting the Public’s Health from Disease, Disasters, and Bioterrorism

GAO looks at ‘extraordinary’ drug price hikes

In a new report (pdf), the Government Accountability Office looks into what caused hundreds of extraordinary increases in prescription drug prices during the past decade. The GAO defines an “extraordinary” price increase as a single hike that more than doubled a drug’s price, an event that occurred regularly throughout the past decade. In their summary of the report (pdf), the GAO summarizes the relevant numbers thus:

From 2000 to 2008, 416 brand-name drug products—different drug strengths and dosage forms of the same drug brands—had extraordinary price increases. These 416 brand-name drug products represented 321 different drug brands. The number of brand-name drug products that had these extraordinary price increases represents half of 1 percent of all brand-name drug products. The number of extraordinary price increases each year more than doubled from 2000 to 2008 and most of the extraordinary price increases ranged between 100 percent and 499 percent. Almost 90 percent of all brand-name drug products that had an extraordinary price increase sustained the new higher price—by either having another increase in price or remaining at the increased price.

More than half of the these extraordinary increases came in drugs in the central nervous system, anti-infective, and cardiovascular classes. According to the report, limited competition and a lack of equivalent drugs (either from generics or brand-name competitors) may be to blame for the price increases. Industry consolidation is also an issue, analysts said, as several drugs jumped in price after their parent company’s acquisition had been finalized.

Related: FDA approval causes drug price to skyrocket

GAO looks into why nursing home evals are flawed

The Government Accountability Office has followed up its May 2008 report that found a high level of inconsistency in nursing home evaluations (PDF) with a blockbuster sequel: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment (PDF).

In this report, the GAO seeks to figure out exactly what’s causing state inspectors to miss serious violations on at least 15 percent of their surveys. The answers? Bad survey methodology, workforce shortages, inexperienced surveyors, bad survey documentation, odd state practices and, most interestingly, outside pressure from stakeholders like those in the nursing home industry.

The entire report deserves a close review, but for now we’ll settle for a few cherry-picked highlights. Keep in mind that while the federal government sets and enforces standards, much of the process, including hiring, training and review of surveyors, is left up to the discretion of the states. For the report, the GAO surveyed 98 percent of state agency directors (Pennsylvania’s Deputy Secretary for Quality Assurance asked that state’s surveyors not respond) and 61 percent of eligible nursing home surveyors.

Practices vary, as do the reasons behind them

“Forty percent of surveyors in five states and four directors reported that their state had at least one practice not to cite certain deficiencies.”

“… over 40 percent of surveyors in four states reported that their states’ informal dispute resolution processes favored concerns of nursing home operators over resident welfare.”

“… directors from seven states reported that pressure from the industry or legislators may have compromised the nursing home survey process, and two directors reported that CMS’s support is needed to deal with such pressure.”

“If surveyors perceive that certain deficiencies may not be consistently upheld or enforced, they may choose not to cite them.”

“Fifty-four percent of surveyors nationwide reported on our questionnaire that supervisors at least sometimes removed the deficiency that was cited, and 53 percent of surveyors noted that supervisors at least sometimes changed the scope and severity level of cited deficiencies. Of the surveyors, who reported that supervisors sometimes removed deficiencies, 13 percent reported that supervisors always or frequently removed deficiencies — including 12 states with 20 percent or more of their surveyors reporting that deficiencies were removed.”

The survey – the length and complexity of which was cited as a contributor to incorrect deficiency reporting – includes 200 standards grouped into 15 categories, which are then rated based on a scope and severity grid.

Scale is always an issue

About 1.5 million Americans live in nursing homes. That’s more than live in Maine, Hawaii, South Dakota or any one of eight other states. Combine this with state budget issues, and you can see how scale would be a serious obstacle to consistency.

“More than two-thirds of state agency directors reported on our questionnaire that staffing posed a problem for completing complaint surveys, and more than half reported that staffing posed a problem for completing standard or revisit surveys. In addition, 46 percent of state agency directors reported that time pressures always, frequently, or sometimes contributed to understatement in their states.”

Does CMS new survey system fix anything?

When the GAO sent out its questionnaires, eight states had begun adopting QIS, which is CMS’ new, and theoretically improved, nursing home survey method (PDF). While the sample size is small, early returns aren’t promising:

There was no consensus among the eight state agency directors who had started implementing the QIS as of November 2008 about how the new survey methodology would affect understatement.44 Three directors reported that the QIS was likely to reduce understatement; three directors reported that it was not likely to reduce understatement; and two directors were unsure or had no opinion… Similarly, there was no evidence that the QIS resulted in higher-quality documentation or improved surveyor efficiency.

Covering the Health of Local Nursing HomesSlim guide:
Covering the Health of Local Nursing Homes

Check out AHCJ’s latest volume in its ongoing Slim Guide series. This reporting guide gives a head start to journalists who want to pursue stories about one of the most vulnerable populations – nursing home residents. It offers advice about Web sites, datasets, research and other resources. After reading this book, journalists can have more confidence in deciphering nursing home inspection reports, interviewing advocacy groups on all sides of an issue, locating key data, and more. The book includes story examples and ideas.

AHCJ publishes these reporting guides, with the support of the Robert Wood Johnson Foundation, to help journalists understand and accurately report on specific subjects.

Other resources

AHCJ resources

  • Aging Nation: Troublesome Health Care Issues
  • Headlines an advocate for seniors would like to see
  • The impact of aging upon health care
  • Covering nursing homes and other issues of aging
  • How will retiring boomers affect the national health agenda?
  • You Can Run, but You Can’t Hide: Policy and Problems in Long-Term Care
  • Biology of Aging: Sources and Resources
  • GAO: Flu-fighting plan needs better measures

    The United States Government Accountability Office today released the catchily titled “Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement” report. See the highlights here.

    It does not specifically address the response to the H1N1 pandemic but instead reviews compliance with the Homeland Security Council’s 2006 “Implementation Plan for the National Strategy for Pandemic Influenza.” The GAO analyzed 60 randomly selected action items from the 324 recommended in the report and sought to measure both how the completion of those items was monitored and how many had actually been completed.

    The GAO found that while the Homeland Security Council had reported that the majority of the action items were complete in 2008, it was “difficult to determine the actual status of some of the 49 designated as complete.” To rectify this, the GAO recommended that “future progress reports would benefit from using measures of performance that are more consistent with the action items’ descriptions.”