Hinchey Leads Bipartisan House Coalition In Calling For FDA

April 28, 2006

One week after the Food and Drug Administration (FDA) issued a baseless, one page press release claiming that marijuana had no medical benefits, Congressman Maurice Hinchey (D-NY) led a bipartisan group of 24 House members in calling on the agency to explain its reasoning and show scientific proof to support its view.

Hinchey, who has offered an amendment in the House three times that would bar the federal government from prosecuting medical marijuana patients, doctors, and suppliers in states where medical marijuana is legal, and his colleagues said the FDA's action appears to be politically motivated and defies the results of a White House-commissioned Institute of Medicine (IOM) study from 1999 that detailed the benefits of medical marijuana use.

"Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials," Hinchey and his colleagues wrote in a letter sent today to FDA Acting Commissioner Andrew von Eschenbach. "It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date."

On April 20, the FDA issued a one-page press release without any documentation to back up its claim that, "...No sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." This statement fails to take into account the IOM report from 1999, which found that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials.

"We saw it with the agency's decision on the emergency contraceptive, Plan B, and we're seeing it again with medical marijuana: the FDA is making decisions based on politics instead of science," Hinchey said. "The FDA should not be a political entity. Rather, the agency should be in the business of ensuring all Americans have access to safe and effective drugs, including medical marijuana."

Hinchey and his colleagues noted in their letter to von Eschenbach that the FDA has an Investigational New Drug (IND) Compassionate Access Program, which allowed some Americans with certain medical conditions to apply to the agency to receive marijuana from the federal government. Seven people are currently still in the program and routinely receive marijuana from the federal government. The House members suggest that the IND is an example of how the FDA could allow for the legal use of marijuana without having to go through the series of steps many other drugs go through before getting approved.

Hinchey intends to offer his medical marijuana amendment for a fourth time when the House takes up the Science, State, Justice, and Commerce Appropriations bill for Fiscal Year 2007. The measure would prohibit the U.S. Department of Justice from spending any funds in its budget to prosecute patients, doctors, and others who are associated with the use of medical marijuana in states that allow the drug from medical purposes.

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The text of the letter from Hinchey and his House colleagues to FDA Acting Commissioner von Eschenbach follows:

April 27, 2005

Andrew C. von Eschenbach, M.D.
Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. von Eschenbach:

We are troubled by the FDA's April 20th press release in which the agency states that "[N]o sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." The timing and the lack of substantial information included in this release lead us to conclude that this was a politically motivated statement rather than one based on scientific evidence and fact.

Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. In conjunction with the lack of scientific evidence, it is troubling that your release seemed to defer to the DEA's medical opinions on the drug despite the fact that determining the medical importance of a drug is not in the DEA's jurisdiction.

After deferring to the DEA, your release reads that, "FDA is the sole federal agency that approves drug products as safe and effective for intended indications." Why then has the FDA failed to respond to the 1999 Institute of Medicine (IOM) report which concluded that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials? It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date. Additionally, this release failed to make note of the FDA's Investigational New Drug (IND) Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana. Currently, seven people still enlisted in this program continue to receive marijuana through the federal government. The existence of this program is an example of how the FDA could allow for the legal use of a drug, such as medical marijuana, without going through the "well-controlled" series of steps that other drugs have to go through if there is a compassionate need.

In light of our concerns over this release, please inform us if there is new scientific information that disputes the IOM study, including the results of the evaluation, any scientific paperwork generated in the study, the length of time the evaluation occurred, and whether the DEA or any other federal agencies aside from the ones mentioned in the letter had a role in the evaluation. If, as the press release leads us to believe, there is in fact no evaluation, please let us know what motivated the FDA to write a release that lacks scientific review. It disheartens us to see the FDA veer off course in this area of public health especially at the expense of many terminally ill Americans. We understand that FDA's mission is to protect public health, which is why we respectfully request that you respond to these questions on this very important issue.

Sincerely,

Maurice Hinchey (D-NY)

Ron Paul (R-TX)

Barney Frank (D-MA)

Sam Farr (D-CA)

Tammy Baldwin (D-WI)

Raúl Grijalva (D-AZ)

Robert Wexler (D-FL)

Dennis Kucinich (D-OH)

John Conyers (D-MI)

Maxine Waters (D-CA)

Dana Rohrabacher (R-CA)

Jim McDermott (D-WA)

Tom Lantos (D-CA)

Jerrold Nadler (D-NY)

John Olver (D-MA)

Lois Capps (D-CA)

Julia Carson (D-IN)

Peter Stark (D-CA)

Jan Schakowsky (D-IL)

George Miller (D-CA)

Zoe Lofgren (D-CA)

Tom Allen (D-ME)

Barbara Lee (D-CA)

Gary Ackerman (D-NY)



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