Title: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes.
Sponsor: Sen Kennedy, Edward M. [MA] (introduced 4/10/2007) Cosponsors (None)
Latest Major Action: 5/1/2007 Senate floor actions. Status: The committee reported substitute amendment was modified by Unanimous Consent.
To read the complete bill, go to Library of Congress - Thomas. Enter into the Search Box the bill number and click the box for "search by number".
S.1082 legislation sponsored by Sen. Kennedy has now been renamed the Enhancing Drug Safety and Innovation Act of 2007, reports Brenna Hill of the Health Freedom Foundation and American Association (www.HealthFreedom.net).
The bill is being hotly debated and has been delayed by two days due to the introduction of various amendments. The health freedom community is continuing its grassroots efforts to rally public support for defeating the bill, even while some lawmakers such as Sen. Byron Dorgan are proposing much-needed amendments that would vastly improve it.
See NewsTarget for ongoing commentary on this bill
I, John Hammel, invested in a legal consultation and paid one of the top Washington DC lawyers that defends against FDA actions $500 an hour to review the initiative and provide his impression of the proposal.
After reviewing his analysis and consulting with two other attorneys, my take is that this proposal does not warrant a response.
The primary reason for this? The Guidance does not create any new regulations; rather it's an explanation of how the FDA applies the existing regulations.
The Guidance explains the differences between foods, food additives, dietary supplements and drugs, and it explains how the same item may be considered a food, a dietary supplement, or a drug depending on the labeling and claims made.
Analysis and Comments by the NHF - National Health Freedom - Click Here
My Attorney's Review of the Legislation
I am rather surprised that FDA issued this guidance document because it does not tell us anything that we didn't already know, i.e., FDA has the regulatory authority to regulate products and devices that are used in the practice of complementary and alternative medicine.
The key words are "products" and "devices." FDA stops short of stating that it has the ability to regulate the practice of medicine. For instance, any topical or ingestible product that is market for the cure, mitigation, treatment, diagnosis, or prevention of a particular disease condition is considered a "drug" by the agency. There are numerous cases on this point going back decades regarding FDA's regulatory authority over such products so FDA's position is well-founded on this issue.
However, in recent times, FDA has generally ignored this area of medicine and has left it to individuals to pursue the course of treatment they believe is necessary as long as FDA did not perceive that the product or device did not pose a risk to public safety. Thus, this document does strike me to be a new attempt by FDA to reassert itself in this space.
How serious the agency is about reasserting itself is difficult to gauge because the key to determining whether a product is regulated as a drug, medical device, cosmetic, food, or dietary supplement depends on the products intended use.
Specifically, intended use is generally determined by the product's label, labeling, and on occasion advertising. Thus, if a company were marketing its dietary supplement product with appropriate structure/function claims, FDA could not seize the product because practitioners are using it to treat their patients.
Moreover, FDA would be hard pressed to take action against a practitioner because how a practitioner uses an otherwise lawful product is within the practice of medicine, which FDA does not have regulatory authority over. With that said, practitioners that have developed their own line of supplements could be challenged by the agency on this issue.
So, I do have some concern that FDA may be indicating that it could regulate transactions between a doctor and their patient. However, this document stops short of stating that FDA would or could.
The few instances that I know of where the agency has arguably attempted to regulate the practice of medicine is with medical devices and controlled substances, in particular hGH. In the 1990's, FDA went after several doctors who were using TENS units in their practices. The units being used, however, had not received clearance from the FDA.
Thus, FDA's argument is that it was not regulating the practice of medicine, but rather the TENS unit itself. FDA was successful in eliminating those units from the doctors' offices because the devices lacked the proper regulatory clearances to be marketed in the United States. It is another matter, however, where a product is properly marketed but a practitioner is not using the product consistent with its intended use. In this latter scenario, the agency would likely avoid taking regulatory action because the status of the product is legal.
For instance, there are now several TENS devices that have been cleared by FDA. If a doctor chose to use one of those devices in a manner not consistent with its clearance, this is arguably not an FDA issue unless the manufacturer or distributor of the device is promoting it for an off label use. Indeed, the courts have generally recognized a physician's right to use or prescribe a lawful drug for a use not indicated on the particular product's label or labeling.
I have also seen FDA as well as the Drug Enforcement Administration ("DEA") take issue with the off-label use of controlled substances, in particular anabolic steroids and hGH. However, the Controlled Substance Act does provide a reasonable basis for the agencies to regulate the practice of medicine when it comes to these particular substances. So, I do not consider this situation analogous.
In Summary
While I am surprised that FDA issued this guidance document, it does not contain anything new regarding FDA's position that the products and devices used by complementary and alternative healthcare practitioners are subject to its regulatory authority. Indeed, FDA has steadfastly taken the position that if these products are marketed to cure, treat, mitigate, diagnose, or cure disease; the products are subject to FDA's regulatory authority as a drug, biologic, or medical device.
The guidance 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. However, there is some implication that if the product is the practitioner's own product that FDA could take issue with it even if the product is properly label in the first instance. Whether FDA is willing to actually pursue a practitioner over an otherwise legal product is doubtful because it raises serious issues of whether FDA is attempting to interfere in the practice of medicine.
With that said, if the product is being marketed unlawfully, FDA believes it has the authority to pursue the unlawful use of the product because it is not attempting to regulate the practice of medicine but simply removing an unlawfully marketed product from the marketplace.
For Health Freedom, John C. Hammell, President International Advocates
for Health Freedom 556 Boundary Bay Road Point Roberts, WA 98281-8702 USA
http://www.iahf.com jham@iahf.com 800-333-2553
N.America 360-945-0352 World
To read the Summary and Major Provisions of S.1082, click here.
Wednesday, May 2, 2007: Senate resumes consideration of S. 1082, the F.D.A. Authorizaion bill.
To view comments by Dr. Mercola, click here.
Bill S1082: The Food and Drug Administration Revitalization Act (also called the Prescription Drug User Fee Act of 2007) is one of the greatest scams and con jobs ever foisted on the American public. Current FDA management is grossly incompetent on the subject of drug safety. This new legislation drastically increases FDA management's power. Each day innocent citizens die at the hands of Big Pharma oftentimes while the FDA hides known risks and condones the very drugs that cause harm all in the name of profit at the expense of human health. See my extensive analysis of this legislation. To view the article by Byron Richards, click here.
By Byron Richards
Con Job Unfolding New Threat to Dietary Supplements Emerges
Posted May 1, 2007: 5:30 PM Pacific
On Monday, April 30, 2007, Senator Edward Kennedy, consistently stumbling on his words and unable to look up (its hard to look anyone in the eye or speak clearly when you are lying through your teeth), sought to convince the American public that bill S1082 was true and meaningful drug safety reform.
The latest information is that Kennedy and Enzi will now consider various amendments to S1082, which may last a day or two. Kennedy will evaluate these amendments, not on the basis of meaningful reform, but on the basis of how many votes he needs in order to get S1082 to pass. He is expected to reject Senator Grassley's meaningful drug-safety amendments there could be some fireworks (tune in to C Span if you want to watch). A full Senate vote could happen tomorrow, although it is most likely to be later this week.
Don't be deceived, this is Big Pharma backed legislation concocted in close harmony with the dysfunctional FDA management team and is designed specifically to bring riskier medications onto the market with hardly any safety or effectiveness testing. As Kennedy and Enzi both stated on the floor of the Senate today drug safety will now depend on the FDA linking to health care databases and looking for trends. Yes, that's right, the inept FDA will now track safety "real time" as the drug companies perform their experiments on the public. In other words, the practice of medicine will now officially be one large clinical trial.
A New Threat to Dietary Supplements Emerges
Senator Kennedy announced that he was working with Senator Richard Durbin (D-IL) to include Durbin's food safety legislation as an amendment to this already overbroad package of FDA reform. For those of you who may not know, Senator Durbin is the number one vitamin-hating senator in the Congress. His currently proposed food bill (S654) would have the net affect of repealing DSHEA (current supplement law that gives us our health freedom) and reclassifying and regulating dietary supplements as drugs. Originally, it was not included in S1082.
At this time, nobody knows what Kennedy and Durbin are crafting but it can't be good.
Thus, health freedom and dietary supplements are now under assault from several aspects of this legislation. Keep up the pressure and keep flooding the Senate with objection to S1082.
S. 468: Food and Drug Administration Safety Act of 2007 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes.
S. 467: FACT Act A bill to amend the Public Health Service Act to expand the clinical trials drug data bank.