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The FDA's CAM "Guidance" - Interview with Senior FDA Science Advisor Philip Chao PDF Print E-mail
Written by John Weeks   

The FDA's CAM Guidance:  Interview with the FDA's Co-Author and Senior Scientific Adviser Philip Chao

Summary: The February 27, 2007 Federal Register informing the public that the FDA was issuing a "Guidance" document on complementary and alternative medicine. The issuance has caused a furor on the internet and among the natural health and integrative medicine community. What's up? Over 90,000 protest messages, to one account, have been received. In the eye of the storm is on Philip Chao, senior scientific advisor for the FDA and a co-author of the FDA's Guidance document. I queried Chao three times about questions on the Guidance raised by both level-headed observers, and some who are well over into the hysterical. Here is a composite of those Integrator interviews with Chao.
Amidst the myriad calls to investigate the meaning of the Guidance for Industry on Complementary an Alternative Medicine Products and Their Regulation by the Food and Drug Administration issued by the Food and Drug Administration (FDA), one interviewee shared this long-time experience with the FDA: "Every time I have called up someone there, they have been available and very helpful."

Image This has been my experience of
public official Philip Chao. Chao works inside the FDA, a part of the United States Department of Health and Human Services. He wears the title of senior scientific advisor in the FDA's office of policy and planning. Chao was the only official referenced in the Federal Register announcement. (Did he draw the short straw?) He has taken the brunt of the heat since. I spoke with Chao at the beginning, middle and end of my research process. Now, I know from the tone of much I hear orally on have read online that to accept that tone as anything but hidden maliciousness is to give the lamb long odds of a good nights' sleep after lying down with the lion. I jokingly asked him at one point if it was really true that his middle name was "Darth Vader." Chao said: "No it is not. But from some of what is being said and written, that depends on who you are asking I guess."

I thought it would be good to get Chao's perspectives on the record. I believe I have asked all the key questions that were put to me by people I interviewed. Your comments, as always, are welcome.
______________________________

Integrator:  What was your role in preparing the Guidance?

Chao: I was one of the people who wrote it.

Integrator: Does this document change any law or regulation?

Questions on Changes in Laws, Referral, Medicalization

Chao: This Guidance on complementary and alternative medicine like all such FDA documents only represents FDA thinking. It does not change any law. It's all there in the black box at the beginning of the document. The document represents the FDA's current thinking on the topic.  As it says, the document "does not create or confer any rights for or on any person and does not operate to bind FDA or the public." Laws are made by Congress.

Integrator:
There are some assertions on the internet that this document will put use of supplements and use of alternative therapies in the hands of medical doctors only, and will require a medical doctor's prescription.
Image
Chao:  This document does not require licensed physicians to dispense. It does not effect who prescribes or dispenses. Nor does it talk about the subject of referral. Nor does it turn supplements into drugs.

Integrator:  The document says that juice may be considered a drug by the FDA in some situations. Does this mean that the FDA could swoop in and raid a practitioner if they were using a juice or a supplement as part therapy for a disease for which that agent was not specifically approved? Or if a practitioner used some device for a medical purpose that does not have FDA approval?

Non-regulation of Practitioners and "Off-Label" Uses

Chao: Listen, the FDA does not regulate practitioners. We regulate drugs, devices, biological products, foods, cosmetics, devices, dietary supplements. If a product falls within a statutory definition of one of these categories, then the product may be subject to regulations pertaining to that product. We do not regulate how practitioners prescribe products. The practice of medicine is a state matter.  If the makers of these products make claims that they are good for a disease, then that is a concern for us. Look at the allopathic side. Doctors can prescribe for off-label use. We don't regulate that. It's a state matter.

Integrator
: So that is what the use of a supplement or cranberry juice that is not approved for medical purpose - off-label use. Many are concerned that your introduction of the concept of "CAM products" may be the initiation of a new category, that over time this could have specific new meaning and case-thinking attached to it. They are concerned that this is part of an FDA plan of some kind.

New paradigms - Is "CAM Products" a new category?

Chao: The only reason the guidance uses this concept is we have a sister agency, NCCAM (NIH National Center for Complementary and Alternative Medicine) which has a classification system for CAM. We thought the domains created an organizational sytructure for discussing CAM products. The Guidance uses the term "CAM products" as a matter of convenience as seen on page one, instead of "products used in CAM."

Integrator
: So this is not setting up a new category?

Chao: The statute tells us what we can do. We use the legal tools we have. We can't unilaterally change the statute.

Integrator:  There are some who are concerned that they are engaged in new paradigm way of using health promoting therapies and approaches that are not exactly structural and function situations, that deal with disease, but deal with disease in a new paradigm fashion and that these will be at risk.

Chao
If someone wants to introduce a new paradigm, they wound need to change the law. We can't unilaterally change the statute.

The FDA and the Dark Side

Integrator:  A couple of other things. There is some concern about this coming out under the Center for Biologics Evaluation and Research. Usually dietary supplement issues are managed by either the Center for Food Safety and Applied Nutrition or the Center for Drug Evaluation and Research.

Chao: Four Centers were involved. It's right there on the second page of the document. [Those mentioned, plus the Center for Devices and Radiological Health.]

Integrator: A technical but meaningful thing on the date for the closure of comments. One interested party figured out that Federal Register notice was on February 27, 2007, the document says that there will be a 90 day comment period which would take us to May 29, 2007. Yet the comment period only runs until April 30.

Chao: Yes there is a discrepancy. Several people have pointed this out. When we drafted this in December it said 90 days. There is a discrepancy.

Integrator: Do you plan to extend to the 90 day point?

Chao:  There has been no decision to do so yet.

Integrator: Can't you see how, with a suspicious public out there and all this hoopla that just extending to 90 days from February 27 makes some sense. It's kind of a minor technical thing, really. Of course then, you might want to turn off the spigot that has sent a hundred thousand messages your way.

Chao:  There has been no decision to extend.

Integrator
:  (joking) A last question. Is your middle name Darth Vader?

Chao:
No it is not. But from some of what is being said and written, that depends on who you are asking, I guess.

Integrator: Thanks for your time. You have been very helpful.

   
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