FDA Medicine Approval

Fiction:  We must subvert the FDA process by passing bills and initiatives.

“Medical” marijuana advocates claim the FDA study process to make a safe and effective prescription drug would take many years. That is cruel and unfair for ill people to wait for this time consuming process. People should be allowed to use it now, even if it has not been thoroughly studied to see if it is safe and effective.

Fact:  In the interest of protecting patients from unsafe and ineffective drugs, the safety and efficacy process of the FDA cannot be bypassed.

In order for a drug to be accepted as medicine, the drug must first be approved by the Food and Drug Administration (the "FDA"). The federal Food, Drug, and Cosmetics Act, 21 U.S.C.A. §§ 351 to 360, gives the federal government sole responsibility for determining that drugs are safe and effective, a requirement all medicines must meet before they may be distributed to the public. The FDA has not approved crude marijuana as safe or effective, so the drug may not legally be prescribed and sold as a medicine.

There is a strong governmental interest in prohibiting the distribution of crude marijuana as medicine. The federal government strives to protect our citizens from unsafe, ineffective substances sold as "medicines" and from drug abuse, drug addiction, and the abusive and criminal behaviors that marijuana and other illicit drugs often generate.

In Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.D.C. 1994), the United States District Court for the District of Columbia accepted the Drug Enforcement Administration's five-part test for determining whether a drug is in "currently accepted medical use." Id.at 1135. The test requires that:

The drug's chemistry must be known and reproducible;
There must be adequate safety studies;
There must be adequate and well-controlled studies proving efficacy;
The drug must be accepted by qualified experts; and
The scientific evidence must be widely available.
Applying these criteria to crude marijuana, the court found that the drug had no currently-accepted medical use. Drug approval must be based on science and not merely what a group or individual desires

The “medical” marijuana advocates must answer some questions

In order for any substance to be approved as medicine some questions need to be answered:

What peer-reviewed scientific research exists for the listed conditions that provides data on:

        (1) the effectiveness of marijuana use for the condition

        (2) the risks of marijuana use for that condition                      

        (3) the benefits of marijuana use for that condition

        (4) the dosage of marijuana for adults and children for that condition

        (5) the interactions with other drugs and marijuana for that condition

        (6) the impact of marijuana use on other pre-existing conditions

          (7) the alternatives to marijuana use for that condition?

Also, what studies exist that show the frequency of administration, duration of administration, time of administration, in relation to time of meals, time of onset of symptoms, or other time factors, route or method of administration of marijuana for all these medical conditions. These questions must be answered before a drug can be used for medicine. If these studies do not exist, all these conditions should not be included.

Crude marijuana, an impure and toxic substance has no place in the medical armamentarium. It is no more reasonable to consider crude marijuana a medicine than it is to consider tobacco a medicine. Coupled with the medical risk to patients, serious regulatory questions arise that have not been adequately dealt with by “medical” marijuana laws. Those who propose medical uses, or who conduct research on the use of marijuana, have an ethical responsibility not to expose their subjects to unnecessary risks.

The FDA has not approved of smoked marijuana as a medicine, and only the FDA has the power to do this. Smoking is a very poor way to deliver a drug. There is no way to calculate the dose of smoked marijuana because there is no way to determine how much is actually being inhaled. There is no way for the public to determine the strength of marijuana they would use. In addition, the harmful chemicals and carcinogens that are byproducts of smoked marijuana create new health problems. 

Questions of medicine are for the FDA to answer -- not special-interest groups, not individuals, not public opinion. Our medical system relies on proven scientific research. Research is being done on cannabinoids but we are a long way from saying that it is safe and effective. Before the development of modern pharmaceutical science, the field of medicine was fraught with potions. There were as many anecdotal stories about these potions as there are today about smoked marijuana. Many people were convinced that these potions helped them, however, many of these potions were absolutely useless, or conversely were harmful to unsuspecting ill people. Thus evolved our current FDA drug approval process. The FDA process has protected us for 100 years. It is dangerous to undermine it.