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April 26, 2007

S1082: Will FDA Do Away With Pharma's Competition?

The FDA and the drug companies have been very close for some time now, but a new bill, S1082, introduced in the US Senate by Edward Kennedy and Michael Enzi is proposing to arrange a marriage between Big Pharma and its regulatory agency. The drug companies bring a rich dowry, instalments are already being paid through the Prescription Drug User Fee Act (PDUFA) which has allowed the drug companies to provide major funding for the FDA's activities for some years. Of course in return the FDA had to promise to use that money for speeding new drugs to market.

The new bill, which has already passed the relevant committee and is due to be considered by the Senate later this year - it is attached to the obligatory renewal of the PDUFA - goes even further.


Byron_Richards.jpg


One comment by Byron Richards:

"It is hard for anyone to comprehend that the agency that is supposed to be in charge of drug safety is about to become a drug company. It is astonishing that the FDA will now manage a full scale business activity that uses a “non profit” foundation as a shield to avoid international patent problems, protect proprietary rights of its commercial drug-development enterprise, and massively expands FDA regulatory powers to quickly remove anything from the market that is competition to its own products and licensing agreements."

The FDA has shown clearly over the last few decades that it is practically unable to keep Big Pharma in check or protect the health of the American public. But as if the situation was not already serious enough, the FDA "Revitalization Act" as now proposed by Senator Kennedy seems set to institutionalize the incestuous relationship with the industry the agency is supposed to control.

- - -

US HEALTH FREEDOM ON VERGE OF COLLAPSE

By Byron J. Richards, CCN

April 25, 2007

(Original at NewsWithViews.com)

A new attack against health freedom, drug safety, and dietary supplements was launched last week by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY). It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA’s dysfunctional management and legal team – meaning this legislation was written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.

S1082 is a Trojan Horse bill that pretends to address safety issues. Unbelievably, the bill turns the FDA into a drug development company that will expose Americans to new and dangerous biological drugs that have little testing to prove safety or effectiveness. And to top it off, the bill gives broad new regulatory powers to the FDA that can be used to frivolously attack dietary supplements and forward the FDA management’s anti-American globalization agenda.

On April 18, 2007, S1082 was approved by the HELP committee (which Kennedy and Enzi control) and now moves to the floor of the Senate. In a slick move, Kennedy has attached his long-planned FDA/Big Pharma “reform” measures to the renewal of PDUFA (Prescription Drug User Fee Act). Current PDUFA law expires later this year and must be reviewed by Congress. PDUFA allows Big Pharma to pay the FDA fees to speed the approval of its drugs. The new Kennedy bill will increase these FDA bribes to 380 million dollars in 2008, well over 50% of the FDA budget for new drug approvals. This is like paying the mob for protection. Kennedy, by replacing the existing PDUFA law with this new bill (S1082), is ensuring that his twisted legislation is the one that will be put before the Senate for a vote.


The FDA Drug Company, an Agency with New Regulatory Power

It is hard for anyone to comprehend that the agency that is supposed to be in charge of drug safety is about to become a drug company. It is astonishing that the FDA will now manage a full scale business activity that uses a “non profit” foundation as a shield to avoid international patent problems, protect proprietary rights of its commercial drug-development enterprise, and massively expands FDA regulatory powers to quickly remove anything from the market that is competition to its own products and licensing agreements.

This new FDA business enterprise is called the Reagan-Udall Foundation for the Food and Drug Administration. In previous versions of the Kennedy bill it was going to be an independent drug company within the FDA (the Reagan-Udall Institute for Applied Biomedical Research). In the current bill it is a “non profit” collaboration of the FDA, private industry, government funding, and private funding. It is run directly by the FDA even though it pretends to not be part of the government. Under this scam taxpayers will foot the bill for drug development and then be charged outrageous prices for the drugs. Furthermore, the new bill seeks to allow a massive expanse of FDA regulatory power through this new foundation. For example, on pages 106-107 the bill states:

“The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety….The Foundation shall [take] into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including post approval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.”

Through this foundation the FDA is seeking broad new regulatory power that it currently does not possess. This will include the authority to attack any dietary supplement (which are food ingredients) as unsafe based on its use of “Critical Path” technology. This means the FDA will use proteomics (the advanced study of proteins in biological systems) to assess changes in biomarkers (the change in the state of a protein at the molecular level) in order to establish whatever it wants to consider as a risk. The FDA can slant this technology, based on their own personal opinions, to make anything they want appear as a risk – including your favorite dietary supplements that you use to stay healthy.


Deceiving the Public

This new bill panders to concerns of Americans regarding the safety of drugs. This legitimate worry is used by Kennedy and Enzi to garner support when in reality the bill does just the opposite - exposing Americans to almost unfathomable new drug risks and dangers while simultaneously making it possible to remove super safe, therapeutic, and helpful dietary supplements. The entire Critical Path initiative is a plan to race new and untested powerful biological drugs onto the market and experiment on patients all over the country – throwing caution to the wind as far as drug safety is concerned.

While S1082 also pretends to address the issues of drug safety, in reality all the needed Big Pharma loopholes are firmly in place. Additionally, the establishment of a clinical trial database as written in this proposed law will enable Big Pharma to hide experimental and undesirable side effects. Instead of full disclosure we will have a sterilized clinical trial database that will have the net effect of being used as a tool by Big Pharma to promote off label use of drugs. This is a far cry from disclosure that results in safety.

In response to the Kennedy con Charles Grassley (R-IA) immediately attacked the legislation on the floor of the Senate:

“The bill [S1802] does not address the outstanding critical problem that the office responsible for post-market drug safety lacks the independence, lacks the authority to promptly identify serious health risks and take necessary steps that will protect the public. As I think we all agree, the FDA is in desperate need of major overhaul.”

The problem for Grassley, and all Americans, is that his true safety reform measures for the FDA are being held hostage by the HELP committee which is under the control of Kennedy and Enzi. His proposed legislation is S. 468: Food and Drug Administration Safety Act of 2007 and S. 467: Fair Access to Clinical Trials Act of 2007. As Grassley told the Senate:

“Let me be clear: Big Pharma does not like these bills. FDA management does not like these bills. Lobbyists are spending hours upon hours lobbying against these bills…What is wrong with establishing a separate center within the FDA--not outside the FDA, within the FDA--with its only job being that of a watchdog for those drugs already in the market?...What is wrong with supporting a clinical trial registry and results database that also requires sponsors to reveal their negative trials?...I propose there is nothing wrong with any of these proposals.”

The situation is rather grave for all Americans. Kennedy has attached repressive legislation to replace the PDUFA funding thereby ensuring that his agenda will come before the Senate for a vote. The only real opposition to the legislation is coming from Grassley, who is attacking the weakness in FDA reform regarding drug safety and clinical trials. An even greater threat to the public – turning the FDA into a drug company and creating new regulatory powers that can be used to attack dietary supplements and remove them from the market – is being ignored by everyone – until now. Kennedy knows he can defeat Grassley and keep Grassley’s bills from ever seeing the light of day. Can Kennedy defeat the American public? Solving this problem is up to you.


The Secret FDA Agenda – Government Against the People

The FDA is a puppet organization. Its management is a revolving door with Big Pharma, Big Biotech, and Big Agriculture. The behavior of its management team, set by its current leader Andrew von Eschenbach – but fully entrenched in its long and ugly history, is one of acting as a police-force bully to forward the profits of those with money and stamp out all competition (under the false guise of consumer protection). The FDA management fully believes it is above any law that is in its way or any attempt at Congressional oversight. It gives lip service to its safety mission. It is a cult unto itself.

The anti-American FDA is actively seeking to undermine U.S. laws and harmonize our dietary supplement laws with Mexico and Canada. This is being done through the Trilateral Cooperation Charter – an illegal agreement set up with health regulatory agencies in Mexico and Canada. It is part of the campaign towards a North American Union, one which would be a catastrophe for health freedom in this country as dietary supplement laws in Canada and Mexico are far more restrictive than in the U.S.

The FDA would also like to harmonize our dietary supplement laws with the evolving international standards set by Codex, thus branding therapeutic nutrition as dangerous and risky and needing to be sold by Big Pharma or removed from the market altogether (if it competes with a blockbuster category of drugs). Codex is planning to use the same proteomics and biomarker technology that will be used by the FDA’s Critical Path Initiative to remove therapeutic dietary supplements from the international market and force their policies on America, thereby superseding the sovereignty of American law on threat of trade sanctions. The FDA fully supports draconian Codex guidelines to regulate dietary supplements and is working with the Germans to concoct technology to brand nutrients as drugs. The FDA management is as bad as any government agency can get. Under the leadership of Andrew von Eschenbach it has plummeted to an all time low.


What You Can Do

1) Call, fax, phone, and write your Senators and tell them you are opposed to bill S1082 - Food and Drug Administration Revitalization Act. Tell them you want no legislation of any kind that will enable the FDA to frivolously attack dietary supplements. Tell them you do not want Big Pharma funding the FDA with user fees for drug approvals. Demand an independent office within the FDA to monitor drug safety. And tell them you want full disclosure by Big Pharma of all their clinical trials. Tell them you support the Grassley legislation (S467 and S468) which offers true reform of the FDA.

2) Tell your Senators you are completely opposed to any law that would enable the FDA to act as a drug company, such as S1082, which is proposing the formation of the Reagan-Udall Foundation for the FDA.

3) Sign this petition demanding congressional oversight of the FDA’s Trilateral Cooperation Charter – a key point the FDA is using to illegally support the formation of the North American Union while at the same time undermining health freedom. This is the FDA’s front line attack that undermines American law and seeks to harmonize us with the laws of other countries. We must win this battle to stop Codex and preserve our health freedom – including access to therapeutic dietary supplements and all alternative health options.

If S1082 becomes law and the FDA is allowed to enter relationships with foreign countries without any Congressional mandate or oversight we can kiss health freedom goodbye – as well as our dietary supplements. It is time for dietary supplement companies and trade groups to get their heads out of the sand and quit jockeying for position in the New World Order at the expense of the future well being of their own customers.

The issue of health freedom is an issue for all Americans who believe in our constitution and our founding documents. America is the last bastion of health freedom on earth. If we fall, the world will be plunged into a Dark Ages of health. Our future health will be dictated by a multinational sickness industry driven by profits for drug and biologic companies with little to do with real quality of health. This is a crossroads – a moment in time. Health freedom is fundamental to all other freedoms as without health freedom the minds and bodies of a population are easy to control.


- - -


After the bill was to be voted on 30 April in the Senate, it seems now that there is some more time to contact your senators to make sure the vote does not go in the wrong direction.

Sen. Kennedy's S.1082 - the latest news

History and Status

Senator Kennedy's legislation S.1082 has been modified in committee with several key provisions and it has since been renamed the "Enhancing Drug Safety and Innovation Act of 2007." Previous names include: Prescription Drug User Fee Act (PDUFA) and the FDA Revitalization Act.

This modified version of the bill is expected to be on the Senate floor for most of this week. Both Democratic and Republican leadership have committed to passing a "clean" bill without amendments. But Senators are being offered the opportunity to add amendments though the leadership is expected to oppose nearly all floor amendments.

The bill, as it was been sent to the floor, has been vetted with the respective House committees. This is a "must pass" bill because without it new drug and device approvals are suspended. There are two ways to fund the drug approval process. Either the taxpayers are burdened with the cost or the drug and device manufacturers pay from their profits. Currently the manufacturers have to pay, per PDUFA.

When the AIDS community in the early 90s was concerned about drug approval, they petitioned to allow the industry to be taxed so the FDA could hire people to speed the process. In 1992, the Prescription Drug User Fee Act was passed and now must be approved every five years.

Points of the Bill

S. 1082, as reported on the Senate floor has added reforms designed to prevent another Vioxx scandal. There is a new structure for adverse events reporting (strictly for new drugs and devices), evaluation and safety provisions covering labeling and review and enforcement. None of these provisions mention dietary supplements the bill itself is for new drugs and devices and it does not cover foods (functional foods or dietary supplements).

In Section 221, the Reagan-Udall Foundation, a federally chartered nonprofit organization, is created to assist the FDA with its mission to discover solutions to problems. The foundation would not be involved in developing new drugs and the language outlining the functions of the foundation is quite clear. In (c)(1), it states that the foundation will take into account problems identified by the FDA to find solutions to problems in the development, manufacturing and evaluation of the safety and effectiveness including post-approval of drugs and devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics. Under DSHEA, the FDA is already responsible for the safety of food/food ingredients (functional foods and dietary supplements) therefore this foundation is designed to help the FDA through research, find better ways of conducting and improving safety and best manufacturing practices of dietary supplements, as envisioned in the provisions of DSHEA.

There are provisions that talk about intellectual property and patents, but they are referencing things like computer software not actual drug products. This language is very similar to what was used when AAHF helped to create National Center for Complementary and Alternative Medicine (NCCAM) in 1998.

There are also provisions that expand clinical trial registry data and make all results -- good and bad -- available to the public, plus deal with drug developmental problems for pediatric patients. They also cover the expanded access to medical research databases and more complete coordination of efforts across the federal government health research organizations.

There is an extensive conflict interest section (Subtitle D), addressing only personal conflicts of interest not institutional bias. In AAHF's opinion, this is the key flaw that needs to be addressed. We find it very troublesome that the agency that would approve a drug or device is also responsible for reporting the problems associated with those approvals. If these post-approval activities were transferred to another appropriate agency, like the Agency for Healthcare Research and Quality (AHRQ), many of the criticisms of the current system would be reduced.

The legislation covers devices in much the same way and authorizes fees collected from drug companies to be used by the FDA and specifics and expands budget amounts for the agency.

It is important to remember that many integrative health care practitioners use FDA approved drugs and devices in their medical practices. It would be counter productive to cripple new developments of products that may be useful. AAHF is dedicated to the right of the consumer to choose and the practitioner to practice.

We encourage you to write your Senator, using our letter, highlighting the request to move adverse event reporting and other enforcement provisions to AHRQ. Please edit and tell your story.

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
Fax: 703.294.6380
P.S. Don't forget to JOIN, DONATE, TAKE ACTION, and TELL-A-FRIEND!

- - -

Update (9 July 2007):

Special Alert From Vitamin Lawyer Ralph Fucetola

I just received this message from Ron Paul's office. HR.2900 should now be the
focus of our activities.

Speaker Pelosi's office in DC is: (202) 225-4965
If you are not from her district, email her at: AmericanVoices@mail.house.gov

Please reference HR.2900 and ask that it be "brought up under a regular order" to be considered by the House WITH amendments.

Currently the bill is scheduled for 40 minutes of debate and NO amendments, which means Ron Paul's important Health Freedom Protection Act, HR.2117, would not be allowed to become an amendment to this House bill which is now the House companion bill to S.1082, the FDA "revitalization" bill that breezed through the Senate last month. That Senate bill was amended to protect Dietary Supplements and we want to make sure the House bill will also be amended to protect supplements and natural remedies.

To do that, HR.2900 must be "brought up under a regular order" so it can be fully debated and amended.

Please forward this widely.

Ralph.


- - -

Related Articles:

1, Feds eye control of vitamins, supplements – even water!
2, FDA Wants to Eliminate Natural Health Care
S1082 Update Tuesday's Activity. Fight Erupts on Senate floor
As the Senate continues to debate the Big Pharma-friendly sweeping reform of the FDA a new problem for Big Pharma's prize Senators has erupted and quickly turned into confrontation on the floor of the Senate. At stake is at least 10 billion dollars per year in exorbitant Big Pharma profits. In one corner is Big Pharma-puppet Orrin Hatch (R-UT), representing the Kennedy/Enzi drug cartel. In the other corner is a majority of Senators lead by Byron Dorgan (D-ND).

S1082 - THE VOICE OF THE PEOPLE IS BEING HEARD
Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is known all over Capital Hill as Big Pharma-designed legislation. It is running into all sorts of credibility problems. A vote is likely on Monday delayed due to all the opposition flooding the Senate by "we the people."

S1082 UPDATE - SENATE STABS AMERICANS IN THE BACK
For approximately four days Americans lived in a delusional state that they may soon pay drug prices the same as every other country in the civilized world. Euphoria over breaking the Big Pharma monopoly turned to disgust as the chameleon, Senator Edward Kennedy changed sides and lead a contingency of Democrats against fellow Democrats lead by Byron Dorgan.

 


posted by Sepp Hasslberger on Thursday April 26 2007
updated on Wednesday November 24 2010

URL of this article:
http://www.newmediaexplorer.org/sepp/2007/04/26/s1082_will_fda_do_away_with_pharmas_competition.htm

 


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Readers' Comments


Anyone who values the few freedoms we still have, must take the time to act NOW. Our government regulatory agencies are becoming blatant whores, bought and controlled by FDA pimps and their mafia bosses, Big Pharma. The proposed bill, S1082, making the "marriage" official will be the death knoll to alternative therapies. Big Brother will then with the blessings of the government and the FBI control the means by which Americans can exert any personal discretion about their health care. This is paternalism driven by rampant greed the worst of the the worst!
Call. Write. Protest. Before we have to pay extortionary prescription prices for Vitamin C...if it can be bought at all, that is.

Posted by: Stella Reinwald on April 27, 2007 10:17 AM

 


(Found on the Alternative Medicine Forum Yahoo group)

From: "Merrill Goozner"
Sent: Tuesday, May 08, 2007
Subject: Urgent Action Needed on Conflicts of Interest at FDA


Dear colleagues,

We've worked together in the past. I'm asking you to take a few moments out of your busy day today to take action on a measure that would reduce the impact of financial conflicts of interest at the Food and Drug Administration.

Later today, Senators Durban (D-IL) and Bingaman (D-NM) will offer an amendment to the FDA prescription drug user fee reauthorization bill today that places restrictions on the FDA's ability to waive financial conflicts of interest of scientists who serve on its 30-plus advisory committees. While this amendment does not go as far as we'd hoped, it does represent a step forward and would set the stage for a better bill to come out of conference committee later this year.

Contacting Senator Ted Kennedy would be especially helpful. His office has been very reluctant to consider changes in the status quo when it comes to eliminating conflicts of interest from FDA advisory committees.

I know many of you have real problems with the overall thrust of the bill. It does not scrap user fees in favor of general revenue funding. It does not go far enough in enhancing the safety monitoring capacities at FDA. It does not restrict direct-to-consumer advertising.

Still, if any of you have time today, it would be helpful if you could email your senators and Sen. Kennedy asking them to support the Durbin-Bingaman amendment that would reduce conflicts of interest on FDA advisory committees.

The Durbin-Bingaman amendment would:

Limit the number of waivers to one per Advisory Committee meeting.

Spells out a process to allow experts with a financial conflict to present information to the Advisory Committee but not deliberate or vote with the committee.

Enhances FDA's outreach activities for identifying non-conflicted experts to participate in Advisory Committees.

To reach your senator, you can their email addresses and a form on this page:
http://www.senate.gov/general/contact_information/senators_cfm.cfm

You should also send an email to several key staff for key senators, including Sen. Kennedy and Sen. Dodd on the Democratic side and Sen. Enzi and Sen. Hatch on the Republican side.

Those aides are:

Sen. Kennedy (David_Bowen@help.senate.gov and David_Dorsey@help.senate.gov)
Sen. Dodd (Tamar_Magarik@help.senate.gov)
Sen. Enzi (Amy_Muhlberg@help.senate.gov)
Sen. Hatch (Patricia_Deloatsche@help.senate.gov)

Thanks as always for your help on these issues.

Sincerely,

Merrill Goozner
Director, Integrity in Science
Center for Science in the Public Interest
tel: 202-777-8374

Posted by: Sepp on May 9, 2007 11:40 AM

 


To Whom it may concern: I wish to report a adverse drug reaction - cymbalta, lunesta- which my wife Sharon Coalson was prescribed - Nov. 28, \'06 which resulted in her suicide of dec. 12,\'06 -- lunesta prescription filled dec. 4, \'06. she had taken 5 lunesta tablets as prescribed with cymbalta as prescribed and experienced a reaction which led to her suicide. i have supoenaed her medical records and have her list of medical instructions from her doctor. she indicated she was experiencing anxiety when she began taking the lunesta. is there anyone i can report this reaction to.

Posted by: Tony M. Coalson on October 10, 2007 03:48 PM

 















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