To: IAHF List
Subject: LEF Subject to Surprise FDA Inspection on Eve of Congressional Vote on Drug Importation Bill
Date: 23 Jul 2003 17:43:01 -0000
IAHF List: The Life Extension Foundation in Ft.Lauderdale Florida http://www.lef.org has been a serious thorn in the FDA's side for years, and the FDA just subjected them to a 3 day surprise inspection that the Foundation feels was motivated by Pharma lobbying against them.
(LEF is filing a Freedom Of Information Act request with the FDA in an effort to try to procure any internal memos related to the Agency's Inspection. During the inspection, the FDA attacked numerous Foundation dietary supplement products saying they weren't in fact dietary supplements but actually "OTC drugs" and they also attacked the Foundation's magazine articles and advertising calling them "extensions of the product label" saying that "illegal health claims" were being made.
FDA told LEF that as soon as their new Good Manufacturing Practice Regulations go into effect that they intend to "come down hard" on the Foundation. That is a most unwise thing for the FDA to say to LEF, an organization with a solid track record of never backing down in the face of FDA tyranny. FDA appears to be gluttons for punishment. LEF beat the FDA badly following an 11 year court battle in which every single trumped up FDA charge against them was dropped.
Foundation Vice President Bill Faloon feels the likelihood is strong that FDA's surprise inspection was timed to interfere with the Foundation's appeal to the public to call Congress in support of the Drug Importation Bill, which comes up for a vote late tomorrow night (Thursday night), actually in the wee hours of Friday morning (like around 1 am or later.)
See information about this bill below. FDA and their pharma clients hate it because it would cut into Pharmaceutical revenues by allowing Americans to purchase lower cost FDA approved drugs from Canada. IAHF shares LEF's view that the government should not interfere with a free market, whether that market be in dietary supplements or drugs- and that there is no justification for blocking consumers from purchasing either drugs or dietary supplements from any country in the world that they wish to purchase them from.
If you are an American, please call Congress immediately in support of the Drug Importation Act discussed below- there is nothing the least bit "unsafe" about FDA approved drugs sold in Canada- LEF is correct in stating that the high cost of Rx drugs are bankrupting nations world wide.
The solution is to allow consumers to buy them from other countries where they are cheaper and to also allow consumers to use dietary supplements for preventive purposes. I share LEF's concern that the surprise FDA inspection they were just subjected to was highly politically motivated by the Pharma Cartel which hates LEF and IAHF for getting strategic information out to consumers enabling them to fight back.
Drug Importation Bill Vote
Scheduled for July 24-25
Call or Email Your Congressional
America is facing a nationwide economic healthcare crisis. One reason for this are overpriced prescription drugs. These same drugs can be purchased in other countries for far less money.
We are asking all Foundation members to call, fax and/or Email to urge their Congressional Representative to pass The Pharmaceutical Marketing Access Act of 2003. If this bill is passed into law, the cost of prescription drugs will be drastically reduced.
The drug lobby has done everything in its power to defeat this bill. You will read about FDA and drug company atrocities to sabotage this drug importation bill in an Email we will send in a few days.
It is imperative, however, that you reach out to your Congressional Representative immediately. It is too late to write. Please phone, fax and/or Email your Congressional representative right away...before the scheduled vote on The Pharmaceutical Marketing Access Act of 2003.
Corrupt bureaucracies will trample basic human rights as long as the citizenry remains passive and apathetic. Please reach out to your Congressman right now! To find your Congressional Representative, call the U.S. Capitol Switchboard at 1-202-225-3121. You can be connected to your Congressional Representatives office directly and ask them to pass The Pharmaceutical Marketing Access Act of 2003. You can also Email or fax your Congressional Representative by accessing www.house.gov
What follows is a letter that can be Emailed or faxed:
The Honorable ______________________
United States House of Representatives
Washington DC 20515
The high cost of prescription drugs is bankrupting the healthcare system of the United States. The only way of resolving this problem is to allow free market forces to compete for my business.
I ask that you support the The Pharmaceutical Marketing Access Act of 2003. This bill would allow drug wholesalers to purchase identical FDA-approved prescription drugs from other countries.
I know pharmaceutical companies are lobbying against allowing consumers to access lower cost medications from Canada and Europe, but I ask that you consider the welfare of your constituents who can no longer afford to bear the artificially inflated costs levied by the pharmaceutical companies. Please do not believe drug company and FDA propaganda that medications sold in Canada and Europe are somehow “dangerous”. This charade has been perpetrated for the purpose of maintaining the quasi-monopoly that forces Americans to pay the highest prices in the world for their prescription drugs.
For factual information relating to the prescription drug cost crisis this nation faces, log on to the Website www.stopfda.org
Please vote for the The Pharmaceutical Marketing Access Act of 2003. I request that you write me concerning your position on this vital issue.
SUMMARY: Pharmaceutical Marketing Access Act of 2003
Americans deserve world class drugs at world market prices!
THE PROBLEM: Americans Cannot Afford Outrageous Prices for Prescription Drugs
The Congressional Budget Office estimates prescription drugs will cost Medicare beneficiaries $1.8 trillion over the next ten years. A $400 billion Medicare band-aid on a $1.8 trillion problem cannot solve the problem.
Two years ago, Congress passed and the President signed into law the Medicine Equity and Safety (MEDS) Act. It was the intent of Congress to allow Americans to import wholesale quantities of lower-cost prescription drugs into the United States. But the promise of this legislation has gone unfulfilled. Even though the FDA largely wrote the bill, they have not implemented the law. What has been the result? Americans continue to pay drug prices that are 30 to 300 percent more than in European and other industrialized nations. Even HHS Secretaries Shalala and Thompson admit that Americans should not have to pay higher prices so that the “starving Swiss” can pay less for the same prescription drugs.
This price disparity is wrong. Despite a second vote in the House in favor of opening pharmaceutical markets (Amendment #150 passed 324 to101 on 7/11/2001 as part of H.R. 2330), prescriptions continue to go unfilled because prices are too high in the United States. Worse yet, the FDA holds a legal dagger over the heads of those Americans seeking better health who attempt to import FDA-approved drugs. Fortunately, with the House drug coverage bill coming to the floor soon, Congress has another opportunity to do the right thing and codify America’s right to open pharmaceutical markets.
THE SOLUTION: Create a Competitive Market So That Americans Can Afford Safe Prescription Drugs
Market Access: Under the Pharmaceutical Market Access Act, the FDA must design and implement a system to grant individuals, pharmacists and wholesalers in America access to FDA-approved drugs from FDA-approved facilities in industrialized nations abroad.
Market Access: Those countries are limited to: the European Union, Australia, Canada, Iceland, Israel, Japan, Lichtenstein, New Zealand, Norway, Switzerland, and South Africa. Note: Mexico is NOT included.
Safety: The Pharmaceutical Market Access Act strengthens America’s commitment to maintaining the safest pharmaceutical drug market in the world. This bill requires all prescription drugs produced at home and abroad to use counterfeit-resistant packaging, similar to the technology used by the U.S. Department of the Treasury. If the technology is good enough to secure U.S. currency, it’s good enough to secure our pharmaceutical chain-of-custody.
Safety: The Pharmaceutical Market Access Act contains language written by the legal team at FDA that requires wholesalers to test each pharmaceutical shipment, unless the packaging uses counterfeit-resistant technology. The FDA’s strict language was written to provide for the safety of imported pharmaceuticals from anywhere in the world.
Safety: The Pharmaceutical Market Access Act strictly prohibits anyone from importing pharmaceutical narcotics, such as OxyContin.
Safety: The Pharmaceutical Market Access Act requires the FDA to implement this program within 180 days of enactment. This frees Americans from an environment where patients forgo pharmaceutical treatments, at risk to their own health, because their prescriptions are too expensive.
STATUTE: The Pharmaceutical Market Access Act recognizes that unaffordable prescription drugs do nothing to improve the health of American consumers. That is an unsafe situation. The bill amends Section 804 of the Federal Food Drug and Cosmetic Act (21 U.S.C. 381) by striking language which requires the Secretary of Health and Human Services to certify that imported drugs pose “no additional risk” to Americans under a market access regime. By contrast, the Secretaries of HHS and USDA are not required to certify “no additional risk” for fruits and meats—food borne pathogens claim thousands of lives each year in the United States. HHS and the USDA have never suggested banning the importation of food. The Pharmaceutical Market Access Act removes this weak language from pharmaceutical legislation and relies on technology and more aggressive safety testing to provide real protections for Americans.
International Advocates for Health Freedom
POB 10632 Blacksburg VA 24062 USA