Is the US Food and Drug Administration (FDA) Approval Process Subverted by Passing Bills and State Initiatives That Legalize Medical Marijuana?
General Reference (not clearly pro or con)
The US Food and Drug Administration (FDA) stated in its Aug. 2004 website section titled “Protecting Consumers, Promoting Public Health”:
“At the heart of all FDA’s regulatory activities is a judgment about whether a new product’s benefits to users will outweigh its risks. Science-based, efficient risk management allows the agency to provide the most health promotion and protection at the least cost to the public.
No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.”Aug. 2004 - US Food and Drug Administration (FDA)
The US Office of National Drug Control Policy (ONDCP), stated on its website page titled “Statement on Marijuana as Medicine” (updated Mar. 4, 2002):
“Designating medicine through ballot initiatives would undermine the long-established process which ensures that substances provided to the American public as medicines have undergone rigorous scientific scrutiny.
This procedure protects Americans from unproven, ineffective, or dangerous treatments. Allowing a purported medication to circumvent federal approval does a grave disservice to the public, because the process guarantees that drugs are safe and effective, that the benefits outweigh risks, and that physicians have had sufficient information to permit accurate prescription.
Making an exception for marijuana would create a dangerous precedent. Medicine must be based on science rather than ideology. Misusing ballot initiatives to exempt medications from proper testing would also give a sales advantage to anyone seeking to market medical products without investing in the requisite scientific research.”Mar. 4, 2002 - Office of National Drug Control Policy (ONDCP)
The Partnership for a Drug-Free America stated in its 2002 Position Statement on Medical Marijuana:
“Voters should not circumvent recognized scientific and medical processes by deciding what constitutes safe and effective medicine via the ballot box. The established processes of the Food and Drug Administration are the foundation on which medicine is defined in this country; together, the medical and scientific communities have established procedures through which all drugs must pass before they can be considered safe, sound and effective ‘medicine’. Marijuana has yet to go through this process.”2002 - Partnership for a Drug-Free America
Rick Doblin, PhD, President of the Multidisciplinary Association for Psychedelic Studies (MAPS), stated in a July 14, 2003 article in Reason magazine:
“As long as NIDA [National Institute on Drug Abuse] is the sole source of supply [for legal cannabis], the FDA [Food and Drug Administration] process will rightly be perceived by the public as obstructed, further fueling efforts by states to circumvent federal authority over the medical uses of marijuana through ballot initiatives or state legislation.”July 14, 2003 - Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin, PhD
David Borden, Executive Director of The Drug Reform Coordination Network, wrote ProCon.org in 2002:
“The FDA was intended to control new medicines, not medicines that had already been in use for hundreds or thousands of years. Morphine wasn’t approved by the FDA. Marijuana should not have been removed from the pharmacopoeia in the first place, and the AMA opposed its banning.”
David Borden additionally wrote on Apr. 21, 2004: “Advocates have resorted to initiatives and lobbying because the government has blocked most medical marijuana research. Studies involving marijuana require a license from the DEA as well as a legal marijuana source.
The only current legal domestic source for marijuana is the National Institute on Drug Abuse (NIDA), however, NIDA has been unwilling to provide marijuana to studies which it is not also funding. DEA has also refused to grant licenses to allow legal marijuana imports for medical research. The same officials who cite insufficient research to meet the FDA’s standards for drug approval have played a role in making sure that the research doesn’t take place.
Recently some studies have been allowed, but not enough to allow the FDA process to proceed at a reasonable pace.”2002; Apr. 21, 2004 - David Borden