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S-1082 - Big Pharma's "Drug Safety" Bill Passes the Senate !!

Byron J. Richards, CCN

warted 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.

Hypocrisy Gone Wild

The bill claimed to be a safety bill and all arguments from either side on any issue were always presented as safety related. Thus, every Senator was using the same set of words to describe both sides of the issue. Each side claimed the other was using the safety term hypocritically, resulting in a bewildering debate. All of this was staged to confuse the public and perpetuate a myth that safety legislation was being meaningfully debated.

What was really being debated was the extent to which the Big Pharma monopoly would be allowed to continue, an issue that was too politically incorrect to describe publicly. The debate was actually about how sharply Big Pharma’s exorbitant profits and reckless behavior would be curtailed compared to how many Americans would be exposed to injury and death at the hands of Big Pharma.

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.

The other key vote came on the Durbin amendment #1034. This amendment sought to prevent Big Pharma from placing “experts” on FDA Advisory Committees – which make the final decisions on the safety of drugs. Durbin argued the obvious point that hundreds of millions of dollars are at stake as well as the lives of Americans and that such flagrant conflicts of interest must be stopped. He pointed out that the FDA Advisory Committee that ruled on the safety of Vioxx had 10 “experts” on the Big Pharma bankroll, resulting in over 50,000 deaths. Kennedy and Enzi argued that these conflicts of interest were necessary and a fact of life and needed for science to progress??? The vote was Big Pharma 47 – Americans 47, and in this case the tie went to Big Pharma and the amendment was defeated. 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.

And we headed off a potential attack by Durbin – who for some reason is always trying to get vitamins classified as drugs (more safety hypocrisy). Key to this effort was myself writing for NewsWithViews.com, Mike Adams writing for NewsTarget.com, and John Hammell of the International Advocates for Health Freedom. Support also came from many other groups who forwarded the message. All of our efforts resulted in the following testimony on the floor of the Senate as reported in the Congressional Record.

May 2, 2007:

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.

Waking up the American public to the larger issue of drug safety is a much more challenging task. Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental research foundation. I will fully document in a subsequent article that this is not the case. It is actually the tool by which Big Pharma and Big Biotech will lock in their profits for the next 50 years, as FDA joins them in the drug development and marketing business. This is one of the greatest safety threats in the history of America.

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.

To get information to contact your Senators follow this link:

http://www.senate.gov/general/contact_information/senators_cfm.cfm

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