let's get the fda/cam issue put to rest

[Guest guest]

---------- Forwarded Message ----------

 

MUCH ADO ABOUT NOTHING

Let's Get the FDA/CAM Issue Put to Rest

April 27, 2007

 

 

 

The greatest threat to a totalitarian movement, once it gains power,

is factuality. Hannah Arendt: Prophet for our Time

 

Refined Guidance Response

By Lee Bechtel, NHF Lobbyist

 

The National Health Federation is hearing from folks and is aware of

what other groups are saying about the FDA Guidance for Complementary

and Alternative Medicine Products issued by the FDA on February 27,

2007.

 

As the NHF lobbyist, my style is to work from the facts. In dealing

with Members of Congress, their staff, and FDA personnel, credibility

is the only stock in trade. And, things do get around to people

involved in FDA issues in both places.

 

Currently, several groups - other than the NHF - are circulating news

about the " end " of dietary supplements and ability of medical

professionals, State-regulated or not, to practice Complementary and

Alternative medical (CAM) professions, as we currently know it to be

the case.

 

What is being consistently lost in the issue translation in these

messages is what the proposed Guidance really means, to CAM providers

and consumers, the intent of the Guidance, and the federal and State

medical regulatory processes in place that will not mean the " end of

the world " as we know it.

 

The Guidance as drafted does not prevent access to CAM providers. It

does not prevent the use of supplements/herbs etc. by medical

professionals in their practice, with limitation, nor does or would

it directly impact consumers/patients. It would not prevent the use

of healthy foods in a diet recommended by a doctor.

 

What the Guidance does do is present current FDA thinking on how CAM

fits within the current context of FDA food and drug regulation.

Again, Guidance is not a regulation, nor is it a law. It confers no

legal impact on the FDA or the public. Guidance specifically relates

to FDA thinking on the design, production, labeling, promotion, and

manufacturing of regulated products. In this case, products related

to CAM medical practice. This includes FDA-regulated drugs,

supplements, and potentially foods, with severe restrictions.

 

Some groups have raised the concern that the Guidance would cause

problems with a CAM practitioner treating patients, in the confines

of their office, with a food, and recommending a food (in this case

orange juice used as an example) that would be translated into a

drug. Specifically, that a CAM practitioner " prescribing " a natural

food to treat a medical condition could lead to FDA action. The same

logic is being applied to dietary supplements.

 

A few facts. First, a CAM practitioner cannot " prescribe " a food in

any event under State or federal laws, because natural foods are not

regulated as drugs. Foods appear nowhere in the classifications of

drugs, regulated by the FDA and the various States. Dietary

supplements are also foods. A CAM Medical Doctor could be

employing " off-label " uses of FDA approved drugs for patient

treatment, which includes a combination of supplement and natural

foods. Prescribing, within the office, only applies to the drug.

There have been attempts, and will be attempts, to blur the line

between supplements claiming a curative or preventative outcome and

their classification as a drug by the FDA. Recommending foods and

supplements is not, under federal law and most State Medical Practice

Acts, " prescribing. "

 

A question has come up and relates to why CAM practitioners should

not be allowed to " practice off-label uses for dietary supplements " ?

This is a completely implausible situation, for the time being. The

FDA and its counterpart State agencies - unless and until Senators

Durbin and Congressman Waxman get their way - regulate supplements as

foods. Yes, there are State FDA agencies not officially affiliated

with the FDA. But there are no federal or State " on label " curative

uses for foods. There is FDA regulation of food-labeling claims, such

as that a cereal helps the consumer reduce cholesterol levels or lose

weight. Without specific FDA approval of " on label " requirements for

specific preventative, mitigative, or curative disease or conditions

for specific foods, however, there are no " off label " matters for the

FDA to regulate.

 

On the fear that the FDA will go after MDs practicing CAM - keep in

mind, that physician/patient medical records and communications are

protected by the federal HIPPA law. If the FDA wanted to go after a

CAM practitioner, based on evidence of using a CAM treatment regime,

they could not get evidence, without violating this law. The FDA

would have to get a patient's written consent to release records.

 

A person could file a malpractice complaint with a State licensing

board, if the CAM profession is State regulated, and then the FDA

could get this public information.

 

This is the case unless a CAM medical treatment goes beyond an office

setting and is advertised for whatever purpose to the general public

as a treatment/cure for a condition. In the eyes of the FDA, it

becomes marketed as a " drug, " even if there is, in fact, only one

drug involved, either on-label or off-label use, used in the

combination comprising the CAM therapy.

 

This point is important and has been around since the creation of the

National Center for Complementary and Alternative Medicine (NCCAM) in

1998. This creation is, in my view, the basic reason for the Guidance.

 

Could there be Guidance transference to States and their regulation

of CAM practitioners? Sure, but the Guidance and the federal

Administrative Procedure Act (APA), Code of Federal Regulations,

provides legal protection.

 

On this point, the Guidance does raise the issue of how far the FDA

can or would go to preempt State medical-practice laws for licensed

CAM professionals. However, FDA Guidance is not federal regulation,

as is stated in the APA. However, State Medical Boards going after

physicians who practice CAM is an ongoing issue, with exception for

several States. This is because there are no

clarifications/exemptions specified for CAM practitioners who are MDs

and DOs. Naturopathic Doctors (NDs) are licensed in 12-13 States,

but, for the most part, are not granted drug prescriptive authority.

 

Federal preemption is a concern, but the Congress has not allowed

this in the past. Clearly, these are State issues and not directly

related to anything the FDA could do, unilaterally on it own. So,

this is simply another fear based on speculation and not on the

facts. The FDA does not, and cannot, regulate the practice of

medicine/healing arts at the State level of government, within the

confines of a CAM provider/patient relationship. This is not my

interpretation. It is spelled out in the Food, Drug, and Cosmetic Act

(FDCA). This applies unless or until a person, a company, a

partnership of both, or anyone else goes public with a CAM treatment

that infers that the combination therapy would prevent, mitigate, or

cure a medical condition.

 

Remember, the FDA Guidance only reflects FDA thinking. And, that

their bureaucrats and the law and regulations are so out of date with

the current practice of medicine that we are where we are when it

comes to the Guidance issue.

 

Process Lost in Translation

 

Some groups have taken the position to specifically file comments on

the interpretation of CAM used in the draft Guidance document. Others

are asking members to send letters to the FDA requesting an extension

in the filing deadline, and suggesting that Members of Congress

should be lobbied to write letters to the FDA to grant a deadline

extension.

 

There are, in fact, two levels of FDA Guidance. In the current case,

this is a Level 1 Guidance. This means that that document sets forth

its initial interpretations of statutory or regulatory requirements

to guide FDA bureaucrats, and the public, when a complementary and

alternative medical treatment is claimed, in the public domain, to

prevent, mitigate, or cure a type of disease or condition - in other

words, when making a drug claim without FDA approval.

 

Unfortunately, none of these messages have placed the issue in the

context of the real world of public policy, and federal and State

regulatory process. To be clear, this outlines the current federal

Administrative Procedure Act, applying to the FDA and its " Good

Guidance Practices. " The CFR/APA citation is Title 21, Section

10.115. People may read this section for themselves, if they want.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?

fr=10.115 & SearchTerm=good%20guidance%20practices

 

The FDA is not required to review any comments sent in before issuing

a Level 1 Guidance. There is a reason. They have to publish notice

and they can request comments, but are not required to respond. If

they do, this helps with the bureaucratic learning curve. Asking

Members of Congress to ask the FDA to extend the deadline is an idea,

but I seriously doubt there will be any takers. There is a reason,

see below.

 

The FDA is required by the APA to review comments and suggestions for

revisions on any Guidance document issued by the agency, at any time,

for either Level 1 or Level 2 Guidances issued by the Agency, from

any groups/people. So, the draft Guidance is not, even if published

in its proposed form, the end of CAM or the use of supplements, as we

now know them to be.

 

Finally, after a Guidance is finalized, the FDA can issue a

Compliance document. This provides more specificity on what the FDA

meant when it issued a Guidance. And, this would also be open for

public comment, and so forth.

 

As the NHF lobbyist, I suggest that all of the players in the health-

freedom community need to keep an eye of what the FDA is really doing.

 

Spreading fear and misinterpreting the facts, in virtually complete

ignorance of FDA processes and without having done the simplest of

basic legal research does not inform people, nor does it do anyone in

the health-freedom community any good.

 

This is not about protecting the FDA. It is not about an FDA

conspiracy. It is about reliable information and experienced analysis

to be more informed about what Congress and the FDA are doing that

really impact health freedom of choice

 

I would also counsel that people should ask themselves WHERE these

other groups were when the NHF was actively lobbying Congress against

passage of the AER bill last December. The answer - Nowhere to be

found. Lost in action!

 

I would also suggest that the players in the health-freedom community

be more concerned about when the FDA issues a Guidance when

implementing the AER law.

 

This applies to consumers and supplement manufacturers as well as CAM

medical professionals. This event will be serious and will deserve

grassroots participation from all parties involved. This will happen

at some point because it is written into the law. Stay tuned to the

true facts and situation. Don't be a lemming and jump off the deep

end just because some misinformed people point the way off the cliff.

Let this be a lesson to avoid listening to them in the future.

 

This Guidance and clarification actually dates back to the FDA's

Strategic Plan in 2000/2004, but it has taken them until 2007 to

produce this draft Guidance.

 

 

 

 

 

 

 

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Supporting this position, veteran food-and-drug lawyer Todd Harrison

of the Washington, D.C. law firm Venable, says " the FDA's CAM

Guidance document does not contain anything new. Indeed, FDA has long

taken the position that if these products are marketed to cure,

treat, mitigate, diagnose, or cure disease, then the products are

subject to FDA's regulatory authority as a drug, biologic, or medical

device. The document stops short of stating that FDA has the

authority to prohibit a practitioner from using a lawfully marketed

food, dietary supplement, cosmetic, or device to treat or prevent a

disease. "

 

 

 

 

 

 

About the National Health Federation

 

Established in 1955, the National Health Federation is a consumer-

education, health-freedom organization working to protect

individuals' rights to choose to consume healthy food, take

supplements and use alternative therapies without government

restrictions. With consumer members all over the world, and a Board

of Governors and Advisory Board containing representatives from 6

different countries, the Federation is unique is being the only

consumer health freedom organization in the world to enjoy official

observer status with the Codex Alimentarius Commission.

 

 

 

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