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Will the Real FDA Please Stand Up?

This e-mail grabbed my attention this week:

TAKE ACTION: FDA Whistleblowers being Fired – HELP THEM.

[Organization] has received an appeal for help to prevent the firing of courageous, honest FDA scientists who risked their careers to save lives by informing Congress about serious safety concerns involving dangerous, FDA-approved drugs and medical devices.

FDA employees should not be afraid to speak honestly and freely about misconduct that threatens the health and safety of all Americans.

This isn’t the FDA that FDA Matters has known and followed for 30 years. Yet claims like the one in this e-mail are persistent and come from many sources.

Many FDA critics—inside and outside the agency—believe the FDA is corrupt, industry-beholden, and arbitrary in its decisions. They allege that the agency is insufficiently concerned about safety and that managers have too much power to overrule staff and suppress dissent.

FDA Matters has itself raised questions about workplace problems at FDA. There are links below to columns on "Dissent and Efficiency: Difficult Trade-offs for FDA," "Why Do Some People Dislike the FDA?" and "FDA: A Hit and a Miss" (about Avandia). Nobody would take the position that all 12,000 FDA employees are happy, fulfilled or satisfied with their work.

Nonetheless, I have always found FDA employees to be committed to the American people and dedicated to the public health needs of patients and consumers.

After spending four years as a government manager in the 1980’s and over a decade as a manager in the private sector, I believe FDA is like most companies or organizations: encompassing a broad range of competency and commitment and having its fair share of job dissatisfaction. From my government experience, I also remember how hard it can be to re-assign government workers who lack commitment or are incompetent or disruptive.

So, would the real FDA please stand up? Is it my very positive experiences or the dark accusations of ethical lapses, industry coziness and harmful suppression of disagreements? How can two such disparate views co-exist?

Forming a consensus and "speaking with one voice" are logical and sensible for FDA, but not an accurate reflection of what usually happens when well-trained, analytically-oriented people with different perspectives gather to make a decision. For example, reviewers focused on the risk-benefit of a medical product are often at odds with reviewers whose focus is safety.

The situation can become more confused when data is open to different interpretation. In such a clash, some people will feel they were not heard or that their views were not considered seriously enough. This is understandable and inevitable. Further, no one can deny that FDA has made some bad decisions and might have done better if it had listened to dissenting views.

However, aggrieved employees may also feel that malicious agency thinking and dictatorial managers have kept their views from becoming the FDA’s position. It is this generalization–from a single instance to the entire agency–that fosters the corrupt image of FDA propounded by agency critics.

I am not persuaded that these critics are right. FDA is making progress in handling dissent and in encouraging managers to be more open-minded. As happened with the Avandia decision, the agency is trying to be honest about disagreements. I am still impressed by the FDA’s self-evaluation of its poor performance in the ReGen medical device approval.

To me, these are hopeful signs, as well as indications that FDA values the nation’s public health above all other interests. FDA makes mistakes, but there is no conspiracy. The agency is fully committed to serving the American people. 


Some related columns:

Dissent and Efficiency: Difficult Trade-offs for FDA
May 9th, 2010

FDA has a reputation for being tough on dissent, whether it comes from employees or regulated companies. It is often alleged that FDA employees with contrary views are re-assigned, marginalized or ousted. Within the regulated industries, there is a widespread belief that arguing with FDA has adverse consequences for a company.
Whatever the truth has been in the past, FDA is trying to develop an institutional cultural that welcomes and accepts dissent from employees, industry and other stakeholders. It is difficult, even messy, to do this. Yet, FDA’s reputation and authority rests on showing that it listened to all competing views–without unreasonably slowing the decisionmaking process. Read the rest of this entry

Why Do Some People Dislike FDA?
October 15th, 2009

Yesterday, I received separate posts from three organizations that are anti-industry, one of which dislikes FDA and one of which hates FDA. They are not alone in these feelings. There are many groups and individuals who believe that industry and physician professional societies run FDA. I don’t accept their premise or the “facts” from which they launch attacks. Read the rest of this entry

FDA: A Hit and A Miss
September 26th, 2010

FDA Matters has watched FDA handle the Avandia decision differently from any prior controversy. I like the new approach. In the same week, FDA provided a status report on its long-overdue social media and Internet communications policy. Because the agency’s efforts have been glacial, the prospect of useful guidance is dim. I think this is a serious problem. Read the rest of this entry

One Response to “Will the Real FDA Please Stand Up?”

  1. The e-mail discussed in this column was a result of long-standing allegations at FDA’ medical device center (CDRH). This update (January 31, 2011) comes from Devices & Diagnostics Letter, published by FDA News:

    OIG Denies Request to Conduct Third Investigation of CDRH
    HHS’ Office of Inspector General (OIG) is rejecting a request to investigate, for the third time, claims from CDRH scientists that they faced retaliation when they raised concerns about the approval of an imaging device. The Project on Government Oversight made the request in a Jan. 13 letter to HHS Secretary Kathleen Sebelius. The two previous investigations were based on criminal wrongdoing rather than regulatory misconduct, the letter says, so the case should be re-examined. In denying the request, OIG is standing by “the results of its original investigation and its subsequent special inquiry,” an agency spokesman said.

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