Posted on Drudge Report Today, Medical Marijuana not.......

[IntrepidEZJ]

FDA Statement
FOR IMMEDIATE RELEASE
Statement
April 20, 2006
Media Inquiries:
FDA Press Office, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine
Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor's recommendation, even though it is not an approved drug.

Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded 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. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.

FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.

A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html

[IntrepidEZJ]

I'm bumping this continually until a response is issued.

Is this correct or incorrect?

[Stokes]

It is true ... the FDA is in the DEA's back pocket.

Not exactly a revelation, and no real coincidence that the release comes on 4/20.

It's clearly another taxpayer funded 'smack in the face' to the hundreds of thousands of suffering medical Cannabis patients across the nation, despite the will of the people.

They've suppressed clinical trials and ignored respected scientific evidence in the name of furthering the profits of the War on Drugs, all at the expense of the sick and dying.

Another crime against humanity by the US GOV.

from the FDA website: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html

Stokes
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Where love is, there God is also.

-Mahatma Gandhi

[IntrepidEZJ]

My point exactly!

Thank you for pointing out the "coincedence" of it being posted on 4-20!

My local newspaper, which buys it's stories from the AP, even made it a top story.

Makes me sick!

How could we counter?

[Stokes]

The Associated Press is a big part of the problem.

It seems that this widely distributed 'news' was created only in response to an 'Inter-Agency Advisory' released by the FDA.

What a joke!

Pure Propaganda, and nothing more.

Danger, Will Robinson ... Danger, Danger!

http://www.mapinc.org/drugnews/v06/n495/a08.html
_________________
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Where love is, there God is also.

-Mahatma Gandhi

[Stokes]

FDA Delay of RX Pot Petition May be Ploy to Put Off DQA Case

FDA Week
April 21st, 2006

HHS for the sixth time has postponed deciding on a medical marijuana petition under the Data Quality Act, according to the department’s Web site. The string of 60-day delays may mean that the government fears the DQA is judicially reviewable, according to a group that supports a policy of judicial review under the data quality law. Industry observers say possible future court action on the medical marijuana issue could set a judicial precedent on the DQA’s legal scope.

An ASA spokesperson says the group will wait until fall before trying to get the courts to force a decision under the Administrative Procedures Act. The source says judges have a lot of discretion under the APA so waiting for further delays will help the group’s case. If HHS is forced to decide and it denies ASA’s request, the group will ask a court to review the denial under the DQA.

The DQA, sometimes called the Information Quality Act, requires that federal agencies justify regulatory decisions with scientific data. If the government disseminates information that a group believes violates the law, the group may petition the government for a correction. However, Congress did not clearly state if courts could review agency decisions, and the Center for Regulatory Effectiveness, which lobbied for the DQA, have been lobbying for judicial review.

A U.S. appeals court recently refused to review an HHS decision on a DQA petition by the salt industry. But CRE says that was a poor case, and hopes the medical pot case will make its way to the courts (see FDA Week, March 30). The CRE is not involved with the ASA petition.

Bruce Levinson of the CRE interprets HHS’ delay to mean that FDA believes marijuana has the potential for medical use, and HHS fears the courts could review their decision.

“If the agency believed that marijuana did not have medical value, they could have rejected the petition and provided their rationale,” Levinson states in an e-mail. “If the FDA thought that the 4th Circuit case was definitive, they could dismiss the petition without any concern of court action. My only conclusion is that the 6th extension reflects FDA unease with both their own formal position on the medical value of marijuana and with their legal position should the issue go to court.”

Americans for Safe Access, which supports medical marijuana, petitioned HHS in October 2004 under the DQA to correct what it argues are misstatements that marijuana and its constituent compounds have no medical use.

“Specifically, in 2001, HHS issued statements in its review of the Marijuana Rescheduling Petition of 1995 that violate both government- wide data quality standards and the HHS guidelines implementing those standards,” ASA writes in the original petition. “The conclusion of HHS that ‘marijuana has no currently accepted medical use in treatment in the United States’ lacks objectivity, utility, transparency, peer review, and public participation. Thus, HHS has failed to ensure that the information it disseminates is based on sound science, as required by [the DQA].”

After some back and forth, HHS April 2005 said it was not acting on ASA’s request. Instead, HHS said it would consider the request in connection with a petition to reschedule marijuana, which has been pending since 2002. ASA appealed a month later. Since then, HHS has delayed answering six times.

http://safeaccessnow.org/article.php?id=3318
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Where love is, there God is also.

-Mahatma Gandhi