Why do FDA auditors wear uniforms on investigations?

Fear_Itself · July 19, 2006, 4:21pm

My wife works at a major medical research facility in Boston that participates in drug trials for pharmaceutical companies. She mentioned that the FDA occasionally performs audits on the trials to make sure they are conforming to FDA standards. The odd thing she mentioned was that all the FDA auditors dress in military-style blue and white uniforms, with epaulets and other military-style accouterments.

Is the FDA empowered as a law-enforcement agency? Do they need to be, in order to wear a uniform? Do auditors from other government agencies (like the IRS) wear uniforms? Is it vanity, like the uniform worn by former Surgeon General C. Everett Koop? Or is it just a nice touch to intimidate those being audited?

Nametag · July 19, 2006, 6:21pm

I’m pretty sure your wife is mistaken. While FDA enforcement agents can carry badges and guns, which are useful for performing some of the hazardous duties related to food handlers and black marketeers, I’ve never seen an actual FDA agent in a uniform. What I have seen are Public Health Service officers in uniform, seconded to the FDA. Since both are under the DHHS, this sort of reassignment is procedurally simple.

I have also heard of FDA agents wearing FBI-style jumpsuits when conducting raids (massive inspections of buses at the borders, for instance), but that doesn’t appear to be what you’re describing.

Fear_Itself · July 19, 2006, 6:33pm

[QUOTE=Nametag]
I’m pretty sure your wife is mistaken.
[/QUOTE]
With all due respect, my wife is perfectly capable of recognizing a uniform when she sees one. She described as being similar to a Navy uniform. What’s more, there were more than one FDA auditor conducting the review, and they were wearing identical outfits, which is pretty much the definition of a uniform. The question is not whether they wearing a uniform, it is why.

Terminus_Est · July 19, 2006, 6:54pm

Nametag wasn’t questioning whether your wife saw uniforms. He was suggesting that they could have been PHS officers in uniform, seconded to the FDA.

Fear_Itself · July 19, 2006, 7:14pm

[QUOTE=Terminus Est]
Nametag wasn’t questioning whether your wife saw uniforms. He was suggesting that they could have been PHS officers in uniform, seconded to the FDA.
[/QUOTE]
I apologize. But I doubt that as well; why would the PHS be involved in an audit? It’s not like they were checking for dirty petri dishes; they were reviewing documentation and protocol to insure the data was valid. I don’t see the public health interest, at least not directly.

cerberus · July 20, 2006, 1:16am

USPHS Commissioned Corps

VADM Richard Carmona, MD

ADM John O. Agwunobi, MD, MBA, MPH

HHS and Commissioned Corps

The PHS CC is just like the old starfleet: all officers. They wear a USN type uniform, with similar insignia. They use a hybrid of titles, though:

They serve in Federal Service slots throughout the DHHS: CDC, FDA, IHS,…

There is a sort of equivalence for the General Service grades (GS) and Senior Executive Service(SES)

friedo · July 20, 2006, 2:29am

Nametag is right. The PHS often assists the FDA in investigations, and the PHS wears Navy style uniforms. (Not vanity. All Surgeon Generals wear the PHS uniform.)

The FDA does have civilian Special Agents who wear suits and may carry guns, though.

cerberus · July 20, 2006, 3:00am

The PHS does not assist the FDA: commissioned officers of the PHS fill FDA billets, just like their civilian GS/SES counterparts. When certain things happen, PHS officers are deployed in teams to deal with those things, but day-to-day, PHS officers operate just like their civilian counterparts.

Yeah · July 20, 2006, 4:07am

[QUOTE=cerberus]
USPHS Commissioned Corps

VADM Richard Carmona, MD

ADM John O. Agwunobi, MD, MBA, MPH

HHS and Commissioned Corps

The PHS CC is just like the old starfleet: all officers. They wear a USN type uniform, with similar insignia. They use a hybrid of titles, though:

They serve in Federal Service slots throughout the DHHS: CDC, FDA, IHS,…

There is a sort of equivalence for the General Service grades (GS) and Senior Executive Service(SES)

A few fine points: No one uses the old “Junior Assistant, Assistant, Senior Assistant, Full, Senior, and Director” titles anymore; too weird. Also, the table you reproduce of military rank equivalents of civil service grades is old. In recent years there has been substantial grade inflation in the Civil Service but little or no grade inflation in the military. Consequently, despite the fact that a lieutenant colonel is officially equivalent (the table has not been updated) to a GS 13, I think you will rarely find a Lt Col in a position that a GS13 would otherwise fill.

Also, PHS officers don’t just serve in the HHS (FDA, NIH, CDC [which includes quarantine officers at ports of entry], Indian Health Service). They also provide medical staff to the Bureau of Prisons and the Coast Guard. Many officers are assigned to the EPA and handfuls are assigned to the DoD, the states, USAID, and various other governmental entities.

Cinemaphiles will remember Richard Widmark as LCDR Clinton Reed, USPHS, in Elia Kazan’s Panic in the Streets (a photograph of Widmark in uniform can be seen at: http://www.infonet.com.br/sysinfonet/images/secretarias/Cinema/richard6.jpg )

Monty · July 20, 2006, 5:57am

Nobody uses those titles anymore? It’s rather odd, then, that they’re still listed in the Corps’ instructions?

Anyway, I understood the case to be that Junior/Assistant/etc. were the actual ranks and that Commander/Lieutenant/etc. were the courtesy titles.

Monty · July 20, 2006, 5:58am

BTW, Yeah, thanks for the photo. I was looking for a good image online to show the Corps crest. The shoulder board in that photo you’ve linked to shows it nicely.

cerberus · July 20, 2006, 12:36pm

Based on my experience at CDC/ATSDR, the GS/PHS chart is correct, with a bit of wiggle: The LCDR/O-4 people I know generally serve as GS-12/13, and the CDR/O-5 people I know generally serve at GS-13/14. Moreover, the CAPT/O-6 people I know serve at GS-14/15, and the RADM people I’ve worked with/seen serve in the SES… in the CDC, the RADM people are Center Directors and above.

The PHS is a uniformed service, but not a military service. It’s basically a set of professional officers, analagous to the medical and engineering officers of the armed services. Unless you’re an intern or something, you’ll actually start at O-3 or so, some start at O-4. Adding to the weirdness is that PHS officers have two grades: a temporary grade, and a permanent grade. So some of those officers wearing O-4 are in reality O-3’s.

And yes, while the PHS titles are still listed, noone uses them, though on paper, the correct title for the O-7/8/9/10 is assistant surgeon general, deputy surgeon general and Assistant Secretary of Health.

Both the Assistant Secretary of Health and the Surgeon General are in HHS, and report to the Secretary of DHHS. The non-HHS assignments are a small proportion of PHS strength.

The device that you see on the boards combines two elements: the fouled anchor and the cadeucus (staff of Hermes). The fouled anchor is an anchor with a chain wrapped about it, and symbolizes a ship in hazard. For some odd reason, the US military and PHS insist on using the wrong staff: the Staff of Asclepius(one Snake) is the proper symbol for medicine.

Yeah · July 22, 2006, 5:52am

[QUOTE=cerberus]
Adding to the weirdness is that PHS officers have two grades: a temporary grade, and a permanent grade. So some of those officers wearing O-4 are in reality O-3’s.
[/QUOTE]

The business of having a temporary and a permanent grade is not all that wierd. The army (and, for all I know, all the other services) used to have the same system. In some ways, the PHS is a bit of a throwback.

[QUOTE=cerberus]
The device that you see on the boards combines two elements: the fouled anchor and the cadeucus (staff of Hermes). The fouled anchor is an anchor with a chain wrapped about it, and symbolizes a ship in hazard. For some odd reason, the US military and PHS insist on using the wrong staff: the Staff of Asclepius(one Snake) is the proper symbol for medicine.
[/QUOTE]

I wouldn’t be surprised if someone DID make a mistake, but some people argue that the staff of Hermes was chosen deliberately. Here is a quote from the Student Encyclopedia Britannica referring to the flag of the PHS: “Quarantine flag adopted 1894. The fouled anchor and caduceus (Mercury’s staff) device represents the service’s original function of providing care for merchant seamen. The same badge in white on a blue field stands for the surgeon general of the Public Health Service.” http://www.britannica.com/eb/article-9018504 (Mercury, AKA Hermes, was the Roman god of merchandise and merchants.)

cerberus · July 22, 2006, 6:23am

The mistake dates back to a US Army medical officer designing a new uniform: he went with the two-snake design (the staff of Hermes), which has nada to do with medicine, but rather is associated with communications and commerce (Hermes was a messenger god). It just sorta stuck after that.

In particular, John Churchill of London, the prolific medical publisher, used a
caduceus printer’s mark on the title page of many of the medical and scientific books he exported to the United States (13). The mark may have symbolized Churchill’s desire to unite medicine and literature because it consisted
of two serpents labeled “medicina” and “literis” and a motto “Irrupta Tenet Copula” (unbreakable bond unites) (23). Nevertheless, John Churchill clearly saw the caduceus as his printer’s mark and not the symbol of medicine be-cause several of his medical books also included prominent representations of the Asklepian (13).

In the United States, however, an erroneous mental connection between Churchill’s caduceus and medical practice seems to have developed. By the late 19th century, several United States–based publishing houses, assuming that the caduceus was a symbol of medicine, had copied or adapted Churchill’s
caduceus printers mark and were prominently displaying it in their medical books (13). Apparently, this misunder-standing was sufficiently widespread in the medical community in the United States to have stimulated the publication of papers condemning the adoption of the caduceus and the neglect of the Asklepian (24, 25).

The important question to ask is how did the caduceus become popular so quickly in the United States. The role of the USAMC is crucial. In 1902, at the suggestion of an assistant surgeon, Captain Frederick Reynolds, a new uniform code was established, and the caduceus became a collar insignia for all personnel in the USAMC. From Captain Reynold’s correspondence with the Surgeon General’s office,
it is apparent that he was unaware of the distinction between the caduceus and Asklepian when he recommended the combined use of the “cock of Aesculapius”
and the caduceus. His statement to the Surgeon General that the Medical Corps of “several foreign powers, notably the English” all displayed the caduceus was also erroneous. In fact, no other western medical military service of that time displayed the caduceus; they all used either the Asklepian or symbols based on the Christian cross (13).

Thus, the adoption of the caduceus by the USAMEDD seems to have been simply a misunderstanding of classical mythologic iconography. Ironically, this mistake was al-most avoided. In March 1902, when Captain Reynolds initially suggested the switch to the caduceus symbol, the Surgeon General, G.W. Sternberg, dismissed his request outright. However, Captain Reynolds was persistent and, later that year, he sent a second letter to the new Surgeon General, W.H. Forwood; this time, his proposal was approved. Thus, on 17 July 1902, the “caduceus of gold” was adopted as the branch insignia of the USAMC (13, 26).

Apricot · July 22, 2006, 7:32am

Well, I’ve been audited by the FDA, the food part, not the drug part.
The investigator wore a nice uniform, similar to a forest service uniform. Durable polyester, dark green, khaki accents, gold buttons.
I supplied her with a lab coat and a hard hat and a hair net, but the uniform seemed appropriate. All our factory workers wear uniforms to maintain cleanliness, and to keep them from having to go home in sticky clothing and do their own laundry. It seemed appropriate that the inspector also be in a clean uniform.

cerberus · July 22, 2006, 7:52am

The PHS does have a role in food safety, but the uniforms are basically US Navy, which supports navy blue(almost black), white and khaki/tan. The PHS does have a field utility uniform akin to BDUs, but I’m not aware of any olive in the PHS uniform kit.

godzillatemple · July 22, 2006, 10:23am

FWIW, I work for a medical software company, also in Boston, and the last time we were audited by the FDA (about 4 years ago) the auditor showed up in regular suit and tie. Maybe because our company produces a “Class 2 medical device” (which is how our software is defined by the FDA) and we are not a research facility, they didn’t need to send anybody in a uniform…

Yeah · July 22, 2006, 3:05pm

[QUOTE=cerberus]
The mistake dates back to a US Army medical officer designing a new uniform: he went with the two-snake design (the staff of Hermes), which has nada to do with medicine, but rather is associated with communications and commerce (Hermes was a messenger god). It just sorta stuck after that.
[/QUOTE]

According to the PHS (http://www.usphs.gov/html/history.html) The PHS seal was apparently developed by John Maynard Woodworth, the first Supervising Surgeon of the Marine Hospital Service, early in his tenure which began in 1871. The PHS site goes on to say, “The caduceus … is often used today as a symbol of medicine, and it is tempting to think that Woodworth intended it to be interpreted in this way. However, the use of the caduceus to represent medicine was not so common in 1871, and it was more often associated with the god Mercury and used to symbolize trade or commerce.”

cerberus · July 22, 2006, 7:41pm

Use of the caduceus in medicine is wrong, incorrect, and reflects either indifference to, or ignorance of, the context of the caduceus.

At the time of its adoption by the US military and US PHS as a symbol, no-one else used it that way, and there were people within the US establishments that opposed it.

At best, the cadusceus was “appropriated” by Dr. Churchill in his publishing concerns, and even there, it was being used in a way not consistent with its historical and cultural context and meaning:

Last time I checked, Hermes didn’t practice medicine. Maybe the idea of a fast courier makes sense in the business of EMTs, ambulances and life flights, but the staff of Hermes has nought to do with medicine.

Asklepius, however had strong connections to medicine, and the Asklepian is the correct symbol for medicine.

As for the PHS Commissioned Corps, the use of the uniform varies. Depending on the circumstances, USPHS officers are actually directed to not wear the uniform. It is not unusual, for example, for EIS officers to wear discreet civvies in the course of field investigations. Additionally, officers billeted to HHS agencies typically do not wear their uniforms every day. Although in recent years, that has changed a bit, with PHS officers being encouraged to wear the uniform more often. And I imagine that people assigned to PHS-dedicated offices wear it every day.

Finally, it is possible that there are civilian GS employees filling FDA regulatory jobs, and that some of these civilian employees are doing field inspection work.

But I still am not aware of a “park service” style PHS uniform. Something else was going on there. If it isn’t black(navy blue), white or tan/khaki, it isn’t a PHS uniform, though possibly at times the PHS will wear Navy-style BDUs in the field.

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Why do FDA auditors wear uniforms on investigations?

The business of having a temporary and a permanent grade is not all that wierd. The army (and, for all I know, all the other services) used to have the same system. In some ways, the PHS is a bit of a throwback.

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