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By Tom Angell for Marijuana.com
Mike Liszewski of Americans for Safe Access told Marijuana.com that FDA’s current approval process for botanicals is “unworkable” and that as a result, very few have been approved. “O’Neill’s appointment could lead to an overhaul of rules pertaining to botanical medicine, which could create a much friendlier environment for research and approval of cannabis and other botanicals,” he said.
Marijuana law reform advocates finally got some potentially good news out of President-elect Donald Trump’s transition team this week following a series of ardent legalization opponents being named to Cabinet-level positions.
Bloomberg News reported on Wednesday that Jim O’Neill, a marijuana legalization proponent, is being considered to lead the U.S. Food and Drug Administration (FDA) under the Trump administration.
If O’Neill is formally appointed and then confirmed by the U.S. Senate as commissioner of food and drugs, it could bode extremely well for future efforts to reform federal marijuana laws.
The FDA is responsible for conducting the scientific analyses of cannabis’s harms and medical benefits that rescheduling rulings are based on. Before the most recent denial of a rescheduling petition by the U.S. Drug Enforcement Administration (DEA) in August, FDA concluded that marijuana has a “high potential for abuse” and “no currently accepted medical use in treatment.”
But there is in fact a lot of scientific research showing marijuana to be medically beneficial and relatively safe. Presumably, under O’Neill’s leadership, FDA would more seriously consider and weigh that literature before making future reclassification recommendations.
O’Neill, a close associate of tech financier and Trump transition team member Peter Thiel, has been active in the movement to reform marijuana laws. For example, he was a founding member of the board of directors of the Coalition for Cannabis Policy Reform, a California-based legalization advocacy organization.
(Full disclosure: The author of this article served alongside O’Neill on the CCPR board.)
On the campaign trail, Trump repeatedly pledged to respect state marijuana policies. But he has already named several ardent cannabis law reform opponents to his Cabinet.
For example, he selected U.S. Sen. Jeff Sessions of Alabama, who recently said “good people don’t smoke marijuana,” to be attorney general. He picked Congressman Tom Price of Georgia, who has regularly voted against medical cannabis amendments, to lead the Department of Health and Human Services. And this week Trump signaled that Gen. John Kelly, another critic of legalization, would lead the Department of Homeland Security. He also tapped Scott Pruitt, the Oklahoma attorney general who led a federal lawsuit against neighboring Colorado’s marijuana law, to lead the Environmental Protection Agency.
With O’Neill at FDA, however, marijuana law reformers would have a key ally in position to help shape the Trump administration’s position on cannabis policy.
O’Neill, who is not a medical professional, previously served in the Department of Health and Human Services under the George W. Bush administration. According to Bloomberg, he is a proponent of a concept called “progressive approval” for drugs, through which substances could be available on the market as soon as they are deemed safe for use even if there isn’t clear data showing them to be effective in treating any particular condition.
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety — and let people start using them, at their own risk, but not much risk of safety,” he said in a 2014 speech. “Let’s prove efficacy after they’ve been legalized.”
Medical cannabis advocates are hopeful that O’Neill would apply his consumer freedom philosophy to natural, plant-based medicines in addition to synthetic pharmaceuticals. Mike Liszewski of Americans for Safe Access told Marijuana.com that FDA’s current approval process for botanicals is “unworkable” and that as a result, very few have been approved.
“O’Neill’s appointment could lead to an overhaul of rules pertaining to botanical medicine, which could create a much friendlier environment for research and approval of cannabis and other botanicals,” he said.
But alluding to possible conflicts that could arise if marijuana’s status under the Controlled Substances Act is changed and it becomes legally available with doctors’ prescriptions, Liszewski said it would remain a key question as to whether existing state-legal cannabis businesses would be protected from harassment by the Justice Department.
“It’s important that whatever positive reforms are made at FDA under the Trump administration should not justify a crackdown on state medical cannabis programs by other parts of the federal government,” he said.
At this point, however, O’Neill’s name is only being informally floated in the press, and the Trump transition team has not officially signaled intent to place him in the FDA post. If he is formally nominated early next year, he would sit for a confirmation hearing in front of the Senate Committee on Health, Education, Labor and Pensions before facing a vote by the full body.