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FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

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Supreme Court Divided on Sales Taxes for Online Purchases

A closely divided Supreme Court struggled on Tuesday to decide whether internet retailers should have to collect sales taxes in states where they have no physical presence.

Brick-and-mortar businesses have long complained that they are disadvantaged by having to charge sales taxes while many of their online competitors do not. States have said that they are missing out on tens of billions of dollars in annual revenue under a 1992 Supreme Court ruling that helped spur the rise of internet shopping.

By the end of arguments on Tuesday, it was not clear whether there were five votes to overrule the 1992 decision, Quill Corporation v. North Dakota, which said the Constitution bars states from collecting sales taxes from companies that do not have a substantial connection to the state.

Several justices expressed concerns about imposing crushing burdens on small businesses that sell goods on the internet and about making them liable for back taxes. Justice Sonia Sotomayor said the case before the court, South Dakota v. Wayfair, No. 17-494, raised “a host of questions” and “a whole new set of difficulties.”

Sounding almost plaintive, she added that Congress, rather than the Supreme Court, was the right forum in which to settle the matter.

“Is there anything we can do to give Congress a signal that it should act more affirmatively in this area?” Justice Sotomayor asked.

But Chief Justice John G. Roberts Jr. said that “it would be very strange for us to tell Congress it ought to do something in any particular area.”

Both he and Justice Elena Kagan said the fact that Congress has so far chosen not to act was itself a telling indication that it was satisfied with the current system.

The chief justice added that the marketplace may already be addressing the problem.

“The bigger e-commerce companies find themselves with a physical presence in all 50 states,” he said, “so they’re already covered.”

The tenor of the argument was a surprise, as three members of the Supreme Court had indicated that they may be ready to reconsider the Quill decision. Justices Clarence Thomas and Neil M. Gorsuch havewritten about their uneasiness with the ruling and the constitutional justifications for it.

Justice Gorsuch seemed prepared on Tuesday to reconsider the Quill decision. “Why should this court favor a particular business model?” he asked.

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