April 2008

Sten Westgard, MS

In an AACC teleconference in December 2007 on "New Developments in CLIA and QC," CMS promoted two new approaches for laboratory quality control, primarily their recommendations for "Equivalent QC" as found in their State Operations Manual, as well as the use of risk analysis for establishing "Alterative QC". The presentation suggested that the FDA might be involved in reviewing manufacturer's recommendations for AQC procedures, as stated in one of the slides:

“Manufacturers may validate an alternative QC proposal; If FDA agrees that the validation shows that the alternative is equivalent to traditional QC, then; Labs may use the alternative QC instead of the CLIA-mandated QC.”

In a subsequent follow-up to this, an official at the FDA noted that the organization was waiting on the science to support alternative QC before moving forward with any plans for an alternative QC clearance process.

So the FDA is waiting on us to develop Alternative QC. And we’re waiting on the FDA to approve it. While we wait, equivocal QC practices are now legal and may become the (sub)standard.

FDA’s troubles

In a followup discussion, Westgard Web was able to clarify that the FDA has yet to make any official committment to the cause of Alternate QC. And it is unlikely that any such committment will made in the near future, given the major problems already consuming the agency FDA. In the last few months, the news about the FDA has not been good.

Food Supply:

About one year ago, FDA inspectors scrambled to inspect Chinese factories that were producing contaminated pet food. The pet food killed a number of dogs and cats and sickened thousands of others:

"'The public thinks the food supply is much more protected than it is,' said William Hubbard, a former associate [FDA] commissioner who left in 2005 after 27 years at the agency. 'If people really knew how weak the F.D.A. program is, they would be shocked.'"
[Alexiei Barrioneuvo, "Food imports often escape scrutiny", The New York Times, May 1, 2007]

Drugs:

"The Food and Drug administration cannot guarantee the safety of the nation's drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told the Congressional Subcommittee yesterday. At the current rate, the agency would take more than 13 years to inspect each foreign establishment once ­ and those are just the factories it knows about."

[ Walter Bogdanich, FDA is Unable to Ensure Drugs are Safe, Panel is Told, The New York Times, November 2nd , 2007.]

Medical Devices:

"The Food and Drug administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators. Computer systems at the drug agency are so inadequate that it can only guess the number of the plants, and it cannot produce a list of those that have not been inspected."

[Gardiner Harris, "For FDA, a Major Backlog Overseas", The New York Times, January 29^th , 2008.

One might be forgiven if, after all these stories, we count ourselves lucky that the FDA is not overseeing QC clearance. It appears that the FDA is not able to assure the quality and safety of its current responsibilities, much less expand its scope.

Overstressed, understaffed, pressured by costs ­ sound familiar?

The problem is not that the FDA is incompetent. It's not. Indeed, whenever we encounter officials from the FDA, we are uniformly impressed by their dedication and integrity. Unfortunately, these admirable individuals are not provided the resources they need to the job. The FDA Science Board, composed of experts and former commisioners, reached a similar conclusion in a recently realeased report titled FDA Science and Mission at Risk. Just look at some of their findings:

• FDA does not have the capacity to ensure the safety of food in the nation.
  
• The development of medical products based on “new science” cannot be adequately regulated by the FDA
  
• There is insufficient capacity in modeling, risk assessment and analysis
  
• The FDA has substantial recruitment and retention strategies
  
• The FDA has inadequate funding for professional development
  
• The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate
  
• The FDA has experienced decreasing resources in the face of increasing responsibilities
  
• Recommendations of excellent FDA reviews are seldom followed
  

Come to think of it, this is a rather familiar list, isn't it? Replace “FDA” with “the laboratory” or maybe “CMS” and the findings reflect the same crisis in our own workplace. Perhaps in some ways, the laboratory is even doing better than the FDA.

What would it take to put the FDA back on track? The FDA Science Board's report estimated that the the FDA budget needed major serial increases in its budget:

• $375 million in Fiscal Year 2009
  
• $450 million in Fiscal Year 2010
  
• $460 million in Fiscal Year 2011
  
• $460 million in Fiscal Year 2012
  
• $460 million in Fiscal Year 2013
  

For those of you keeping score, that’s a budget increase of $2.2 billion dollars over five years that the FDA needs, just to handle the regulatory mandates it currently has. In a future fiscal environment that is going to be parsimonious at best, it’s a safe bet that the FDA is not going to get all the money it needs, and that it will not be able to handle everything on its plate for years to come.

Conclusion: We have to be the leaders we’re waiting for.

In other words, we in the laboratory are on our own. Salvation ­ Alternate QC ­ is not going to come from the FDA anytime soon. Instead of waiting, we’d better start working on other (better) solutions to our quality problems.

Luckily, labs are not required to implement Equivocal QC practices. Luckily, there are manufacturers who are building world class quality into their methods so you don’t have to accept bad quality in your testing. And Luckily, there’s you, who is reading this now and take an interest in quality.

We’ve been waiting for you to stand up for better quality and lead us to the future.