Attorney Jonathan Emord Strongly Recommends We Keep Pushing for an Amendment in the House

IAHF List:

Byron Richard's has done a great job in summarizing whats just happened with passage of S.1082 in the Senate. Please take the time to read his carefully reported article below. Given that the vote just went 93-1 Against the American people, (Senator Bernie Sanders I-Vermont was the only Senator with the courage to stand with the American people), it would be easy for you to conclude that your efforts to make calls, send emails and faxes was in vain- and its VERY IMPORTANT for you to realize that its ALWAYS harder to get amendments to a bad bill like this in the Senate than it is in the House- (where the battle goes NOW!)

OUR VOICE WAS HEARD 

Its also very important for you to realize that at the very least we DID get some statements of congressional intent read into the Congressional record in which Hatch, Harkin, and Kennedy sought to address our concerns about the threat of the language impacting DSHEA. While this is better than nothing, its still VERY IMPORTANT to realize that a STATUTE is only one HALF of the law- the IMPLEMENTING REGULATIONS (which in the case of this bill would be drafted by the FDA) are the OTHER HALF. We can't rest easy based on the assurances of Hatch and Harkin that the language in this bill doesn't pose a threat.

Attorney Jonathan Emord has more experience than any attorney in the country in defending DSHEA in court against the FDA, and HE advises us very STRONGLY to KEEP ON PUSHING for an AMENDMENT to this legislation when it moves to the HOUSE. Just now I talked with Norm Singleton in Congressman Paul's office and they're aware of our concerns and will most likely introduce an amendment in our behalf. When I asked Norm if he had any idea how soon the legislation would start moving in the House, he said he did not know, but it can't hurt us at all to proactively express our concerns NOW, in fact we MUST given the head of steam this legislation has behind it- the Hill is crawling with Pharma lobbyists, and the only chance we have of countering their influence is via massive grass roots action!

They'll probably take the Senate language and introduce it in the House as is and just try to ram it through- but we CAN'T LET THEM!

WHAT TO DO NOW:

1. Read Byron Richard's article (below) for your awareness on what just happened in the Senate.

2. Below his article you'll find a Form letter and phone script to fax in to your own congressman and to the members of the Dietary Supplement Caucus.

3. Please alert all your friends and family so we can continue building the size of our grass roots army.

4. I did not make a trip to the Hill during the Senate battle because I knew this would be going to the House where we'll have our best chance of getting an amendment. Your donations to IAHF will help me make this emergency trip to DC, I'm in communication with people on the Hill and am trying to work out the timing on exactly when to go:

IAHF 556 Boundary Bay Rd. Point Roberts WA 98281 USA or via paypal at http://www.iahf.com/index1.html

S1082 – Big Pharma’s “Drug Safety” Bill Passes the Senate

By Byron Richards, CCN

May 9, 2007

NewsWithViews.com

The Senate has sold out the American people.  Anyone voting for change in the last election can now plainly see the shenanigans of a Democratic-controlled Senate.  Under Republicans no FDA reform ever took place.  Big Pharma owns so many Republicans that all meaningful legislation to curtail the deaths and injuries of American citizens at the hands of Big Pharma and the FDA had been completely thwarted for the past six years.  Under Democratic control sweeping FDA reform favorable to Big Pharma was proposed and the majority of meaningful reform was blocked or seriously watered down.  Which is worse?  As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an “elaborate scheme.”

The final passage of S1082 was never in doubt (final vote was 93-1).  In fact, Kennedy and Enzi gave Big Pharma a 40 yard head start in a 100 yard dash; it wasn’t much of a contest.  Their legislation perpetuated the user fees allowing Big Pharma to buy mob-like protection from the FDA.  The bill created the Reagan-Udall Foundation for the FDA to hold FDA-related patents and allowed the FDA to license technology to drug companies – thus turning the FDA into a drug company with vested interests in specific medicines.  None of these blatant conflicts of interest, which are also primary safety issues, seemed to bother any senators at all.

Earlier in the week a fight broke out between a contingent of Democrats lead by Senator Kennedy (D-MA) and a larger contingent lead by Byron Dorgan (D-ND).  However, when the Kennedy clan joined the Republicans their odd Big Pharma-sponsored coalition held an advantage.  This group of Senators undermined the free market and perpetuated the high cost of drugs in this country compared to all others countries – a 50 billion dollar gift to Big Pharma. 

Double talk became the order of the day.  On the one hand it was funny to watch, as Democrats attacked each other.  On the other hand it was sad to watch, as this pathetic debate will result in window-dressing reform, with enough Big Pharma loopholes to drive a Mack Truck through.  Attempts by well meaning senators to correct flagrant flaws in the legislation were either watered down to the point of nonsense or blocked entirely. 

Many key issues were not addressed, such as the FDA’s legal position to prevent citizens from suing drug companies, the massive (and oftentimes illegal) off label promotion of drugs by the legion of Big Pharma sales reps, medical journals that are full of fraudulent Big Pharma promo pieces that misrepresent the safety and efficacy of drugs currently on the market, and a large percentage of doctors on the take from Big Pharma.

Big Pharma Wins Key Amendment Votes

On the final day it all boiled down to two keys votes.  One vote was on the Grassley amendment #1039 which would have given true power to scientists in the FDA responsible for regulating the safety of drugs already on the market.  The FDA and Big Pharma were adamantly opposed to this amendment.  The vote was Big Pharma 47 – Americans 46, defeating the amendment.  This vote was not only a sell out of Dr. David Graham and other FDA scientists who have gone to Congress as whistleblowers to save American lives, it was an “acid-test” vote on who is truly on Big Pharma’s payroll.  Click here to see how your senators voted.

Two-faced senators threw a dog bone to those promoting safety, as a second Grassley amendment that called for stiffer civil penalties against Big Pharma wrongdoing was approved.

The Senate has punted when given a major opportunity to protect the health and well being of Americans.  S1082 is the best “safety” legislation that Big Pharma money could buy. 

The Voice of Health Freedom was Heard

Many thousands of Americans flooded the Senate with objections to a clause relating to the Reagan-Udall Foundation for the FDA, which could be used to target dietary supplements by evaluating them as drugs for safety purposes.  While Enzi refused to change the language, we created such an uproar that assurances are officially in the Congressional Record that this legislation is not to be used to harass dietary supplements. 

Mr. HATCH. My office has been inundated by calls from people throughout the country who believe that this legislation, specifically the provision establishing a Reagan-Udall Institute, will overturn the Dietary Supplement Health and Education Act of 1994. That has not been my reading of the bill, but I wonder if other Senators have heard similar concerns?

Mr. HARKIN. Yes, I have received a good many calls as well. And, I have to say that I would be very concerned, as I know the Senator from Utah is, if anything in the bill we are considering, S.1082, would overturn DSHEA, a law we fought side-by-side to see enacted.

Mr. ENZI. It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall Foundation for the Food and Drug Administration. That simple purpose of that nonprofit Foundation is to lead collaborations among the FDA, academic research institutions and industry designed to bolster research and development productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make the development of those products more predictable and manageable.

Mr. KENNEDY. That is exactly the purpose of the Foundation, which was included in the drug safety legislation Senator Enzi and I introduced last year. The Foundation will be financially supported by industry and philanthropic donated funds. A chief scientist at FDA will promote intramural research and coordinate it with efforts at the Foundation.

Mr. HATCH. That explanation is very helpful. What, specifically, would the role of the Foundation be with respect to dietary supplements?

Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall Foundation will in no way override, overturn or conflict with the Dietary Supplement Health and Education Act. Nothing in this bill would have that effect.

Mr. ENZI. Yes, we took great pains to make certain there would be no conflict with DSHEA. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.

Mr. HARKIN. So to make this absolutely clear, what you are saying is that the bill we are debating would in no way interfere with consumers' access to dietary supplements?

Mr. HATCH. To add to that point, it seems that the language could, in fact, help dietary supplement consumers, because it would allow collaboration between government and industry to conduct research on issues that might be helpful to supplement consumers?

Mr. KENNEDY. Yes, that is the case.

Mr. ENZI. I agree with Chairman Kennedy's assessment.

Mr. HATCH. I thank you for those assurances and that clarification.

Mr. HARKIN. This has been a very helpful discussion, because Senator Hatch and I could never support legislation that would interfere with DSHEA and we are glad to receive the assurances of the chairman and the ranking Republican on the committee.

On May 1 we sent out another urgent call to action because Durbin was planning an end run around DSHEA that would further attack dietary supplements.  Once again the people flooded the Senate and on May, 3, 2007, Senator Hatch responded to the concerns we raised.  The Congressional Record states:

Mr. HATCH. Mr. President, a number of questions have been raised about how the Durbin amendment on food safety, adopted yesterday by a unanimous vote, would affect regulation of dietary supplements….

For the edification of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That definition includes a proviso that supplements are to be considered foods, except in the instance when a product makes a drug claim. In other words, by Federal law, dietary supplements are generally considered to be foods.

It is for this reason that the language of the original Durbin amendment establishing a new adulterated food registry could have been read to apply to dietary supplements.

This raised problems for me, and indeed for our colleague Senator Harkin, since we had spent more than 2 years working with Senators Durbin, Kennedy, and Enzi to draft, pass and enact the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the-counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis.

As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109-462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin.

Consequently, the amendment we adopted yesterday contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language and thus last year's law would not be superseded. To reassure those who are interested in the Dietary Supplement Health and Education Act, DSHEA, I wanted to take a moment to outline those changes.

First, there is new language in the section establishing the adulterated food registry to express the sense of the Senate that: (1) DSHEA has established the legal framework to ensure that dietary supplements are safe and properly labeled foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act has established a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States; and (3) the adverse events reporting system under that act will serve as the early warning system for any potential public health issues associated with the use of these food products.

In addition, language contained in the Durbin amendment modifies the definition of supplement contained in 201ff of the FFDCA so that supplements will not be considered foods for the purpose of the new adulterated foods registry. This in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods. On the contrary, all it would do is exempt supplements from the registry.

These changes, all contained in the amendment which was approved yesterday, make clear that there are no new dietary supplement requirements in the Food and Drug Administration Revitalization Act. It is my hope this will reassure the many who have expressed concern that Congress was inadvertently repealing Public Law 109-462.

The voice of the people has been heard.  Let us not forget these promises nor let the FDA forget them – as the questionable language regarding the Reagan-Udall Foundation for the FDA still remains. 

The battle now moves to the House and then to a conference committee.  The legislation is being ramrodded through before the general public knows what is happening.  Mainstream media, a primary client of Big Pharma, is intentionally failing to explain the true meaning of S1082.  There is still time for Americans to determine their fate.

Related articles:

1,  Fight for Your Health: Exposing the FDA’s Betrayal of America

     (read free – documents FDA corruption)

2, S1082 – Senate Stabs Americans in the Back 5-7-07

     (The Senate shoots down fair drug pricing for Americans)

3, What is Really Going On at the FDA 5-7-07

     (S1082 - explains the user fee scam and anti-American FDA activities)

4, S1082 - The Voice of the People is Being Heard 5-4-07
     (Citizens are flooding the Senate – Why FDA wants to be a drug company)

5, Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07

     (S1082 – Big Pharma vs American Citizens – Senators used as pawns)
6, Dietary Supplements Threatened, Freedom in Danger 4-30-07
     (S1082 – How drug-safety legislation threatens dietary supplements)

7, U.S. Health Freedom on Verge of Collapse 4-25-07

     (An overview of S1082 and how it undermines health freedom)

The People’s Amendment: S.1082 WHEN ITS INTRODUCED IN THE HOUSE - Please Amend to Protect Dietary Supplements May 7, 2007 The Honorable (Congressman's First and Last Name) Address
Address

Dear Congressman (Last Name);

The issue of drug safety is of the utmost importance to myself and all Americans. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use S.1082 (or whatever number the bill is assigned in the House)  to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. This bill authorizes the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. I am sure you and other Senators were not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with a simple amendment. I am not put at ease by the statements of assurance made by Senators Hatch and Harkin in the Congressional Record relative to my concerns given that a statute is only one half of the law. As long as the FDA gets to make implementing regulations, I want an AMENDMENT to the language as recommended by Attorney Jonathan Emord: 

Proposed amendment to S1082 (Or Whatever they call it in the House):
“The bill, S1082, is hereby amended to eliminate any reference to the terms food or food ingredients within Subtitle B - Reagan-Udall Foundation for the Food and Drug Administration, such that food and food ingredients will not be subject to any jurisdiction or control by the Reagan-Udall Foundation for the Food and Drug Administration.”

Intent of amendment:
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.

(Please FAX the form letter in to the following members of the Dietary Supplement Caucus, also call your own congressman via 202-225-3121 Capital Switchboard to express your concerns, and get their fax number so you can also fax this in to them. 

DIETARY SUPPLEMENT CAUCUS

Congressman Ron Paul  fax  (202) 226-6553

Congressman Dan Burton fax   (202) 225-0016

Congressman Peter De Fazio fax   202-225-0032

Congressman Chris Cannon fax   (202) 225-5629

Congressman Frank Pallone fax  202-225-9665

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