Abuse, Neglect And Corruption
Need to Reform the FDAMay 2001
By Deborah Reivman
FDA reform is crucial because our very lives are at stake. If we don’t tear down FDA barriers against new drug development, those of us alive today may not benefit from the breakthrough therapies that are being discovered in research laboratories. We are also facing an economic healthcare crisis because FDA policies are denying Americans access to lower cost medications.
We are asking all Foundation members to send President Bush the letter that appears on the next page. This letter urges President Bush to force the FDA to implement the law passed by Congress last year that allowed Americans access to lower priced drugs sold in other countries. The importation provisions of this law were nullified on a technicality by Donna Shalala before she left office, BUT, President Bush can reverse Secretary Shalala’s decision and implement these provisions that would drastically lower the cost of prescription drugs.
On the page following the letter to President Bush is a letter you can send to your Congressional Representative to support a bill that would enable Americans to gain greater access to life-saving medications that are bogged down in the FDA approval process. The name of this bill is the Thomas Navarro FDA Patient Rights Act ( H.R. 3677). This bill would amend the law to restrict the authority of the FDA to issue clinical holds regarding investigational drugs or to deny patients expanded access to such drugs. Thomas Navarro is a child dying from cancer who is being forced to first undergo toxic conventional treatments before the FDA will allow him to try a non-toxic approach that has a good track record of success. We will be featuring a story on the heroic efforts of Thomas Navarro’s parents in a future issue of this magazine, but we are asking members to write their Congressional representatives to get this bill signed into law immediately.
Corrupt bureaucracies will trample basic human rights as long as the citizenry remains passive and apathetic. Please sign the letter on the next page and mail it to President Bush at the address that appears at the top of the letter. Then sign the letter on the following page and mail it to your member of Congress. To find out who your Congressional Representative is, call the U.S. Capital Switchboard at 1-202-225-3121. If you want to discuss this with your Congressmen, you can be connected to his office directly. You can also find out who your Congressional Representative is and send an e-mail version of this letter by accessing the Home Page of The Life Extension Foundation (www.lef.org).
The letter that supports the Thomas Navarro FDA Patient Rights Act can be mailed to:
- The Honorable (Your Congressman’s name)
- United States House of Representatives
- Washington, D.C. 20515
President George W. Bush
The White House
Washington, D.C. 20500
Dear Mr. President:
In the year 2000, legislation overwhelmingly passed in both Houses of Congress that allowed the wholesale importation of prescription pharmaceuticals made in FDA-approved facilities.
This law was designed to drastically cut healthcare costs by enabling American consumers to obtain their prescription drugs at a fraction of the price that is being charged in the United States.
In late December 2000, HHS Secretary Donna Shalala unilaterally decided not to implement the provision of this law that would have given Americans access to lower cost medications. Shalala turned down 23 million dollars Congress had appropriated for the FDA to implement this provision that would have lowered the price I pay for my health insurance and prescription drugs.
Secretary Shalala’s decision means that it is illegal today to import wholesale quantities of FDA-approved prescription drugs into the United States. U.S. consumers are thus forced to pay the highest drug prices in the world because the free market competition this law was supposed to create does not exist.
Your administration does not have to abide by Secretary Shalala’s decision to thwart implementation of the wholesale importation provisions of the new law. Based on your comment in the St. Louis debate that allowing importation of lower cost prescription drugs “makes sense,” I request that you instruct HHS Secretary Tommy Thompson to immediately implement the wholesale importation provision of the law passed last year.
You have repeatedly stated that you believe in the free marketplace. As long as the FDA can block the wholesale importation of lower cost prescription drugs, a virtual monopoly will continue to cause me to pay inflated prices for my prescription drugs and health insurance.
I respectfully urge you to instruct Secretary Thompson to implement this law that was enacted by the United States Congress at the behest of American consumers who were fed up with paying grossly inflated prices for medications they need to stay alive.
Please let me know your position on this issue.
City: ____________ ST: _____ ZIP: ________
The Honorable (Your Representative’s Name)
United States House of Representatives
Washington, D.C. 20515
I am writing to ask that you vote to pass the Thomas Navarro FDA Patient Rights Act ( H.R. 3677).
This bill would amend the Food, Drug and Cosmetic Act to restrict the authority of the FDA to issue clinical holds regarding investigational drugs or to deny patients expanded access to such drugs. Passage of this that would enable Americans to gain greater access to innovative therapies that are bogged down in the FDA approval process.
Thomas Navarro is a child who was told he was dying from cancer. He has been denied a promising therapy because of an FDA ruling that states he must first endure radiation and chemotherapy. Thomas Navarro has to wait for these toxic treatments to fail before being allowed to try promising therapies that are not yet approved by the FDA.
In as much as millions of American lives are at stake, I respectfully request that you expeditiously ask your fellow members of Congress to vote this bill (H.R. 3677) into law so that American citizens do not have to die while potentially life-saving therapies already exist.
Please reply to let me know your position on this issue.
City: ____________ ST: _____ ZIP: ________