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FDA grapples with 'Wild West' CBD market

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Cannabidiol is appearing in all kinds of consumer products as the U.S. Food and Drug Administration struggles to come up with guidelines for regulating substance.
These gummy worms displayed at the Cannabis World Congress & Business Exposition trade show in May contain 10 milligrams of CBD.

Source: The Associated Press

During a 10-hour, jam-packed public hearing, top officials from the U.S. Food and Drug Administration said the agency is unsure how to rein in the cannabis market's newest fad: cannabidiol.

Acting FDA Commissioner Ned Sharpless explained during the May 31 hearing that in response to the growing cannabidiol market, the agency is establishing a working group to increase its knowledge of CBD and address unanswered safety concerns regarding the consumption of CBD products.

While the FDA is still grappling with some of the finer points of CBD regulation, the agency is adamant about two things: CBD is a drug, and using that drug in commercial products is illegal.

The agency's tough-on-CBD rhetoric seems to be having little effect, however. Stores and websites continue to illegally market the products with little interference from the FDA. Some witnesses at the May 31 hearing described the market as "the Wild West."

"Ladies and gentlemen, the genie is out of the bottle and it is probably impossible to force it back inside," said Colorado lawyer Dave Rodman, whose law firm represents cannabis growers, investors and dispensaries.

Story: US FDA grapples with dosing, drug interaction questions in new CBD terrain

Must read

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Sanofi CEO Olivier Brandicourt will step down in September.

Source: Sanofi

Sanofi poaches Novartis' Paul Hudson to take over as CEO Brandicourt steps down

Sanofi poached Paul Hudson, Novartis AG's head of pharmaceuticals, to take over as CEO after Olivier Brandicourt said he will retire from the helm at the French pharmaceutical company.

Recruiting top scientists to handle emerging technologies is FDA's greatest concern

Recruiting and retaining top scientists with the expertise needed to review applications for emerging technologies is the U.S. Food and Drug Administration's greatest concern right now, the agency's top leaders said.

US Supreme Court blocks billions in Medicare spending cuts for certain hospitals

The U.S. Supreme Court stopped billions of dollars in Medicare cuts for hospitals that serve high volumes of low-income patients, saying the U.S. Department of Health and Human Services violated notice-and-comment rules when making the changes.

Analysis backs up Pelosi drug price idea; FDA provides Right to Try clarity

House Speaker Nancy Pelosi's proposed plan for a scaled-back version of Medicare drug price negotiations got some new support from a group of patient advocates, and regulators provided new clarity for patients on the Right to Try Act.

Science academies: Climate change poses big risks to human health in Europe

The report also found that moving to a zero-carbon economy could, annually, prevent hundreds of thousands of premature deaths in Europe and about 3.6 million deaths globally caused by air pollutants emitted from fossil fuel-fired power plants.

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ASCO meeting

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The 2019 American Society of Clinical Oncology meeting that took place from May 31 to June 4 brought together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on site and an additional 3,200 abstracts to be published online.

S&P Global Market Intelligence's Healthcare news team covered dozens of clinical trial results throughout ASCO week.

Merck, AstraZeneca, Amgen studies stand out from the pack

From AstraZeneca PLC and Merck & Co. Inc.'s Lynparza in pancreatic cancer to Merck & Co. Inc.'s Keytruda in lung cancer and Amgen Inc.'s new KRAS inhibitor, study results showed that targeted drugs have the ability to raise the life expectancy of patients around the world.

Merck, Bristol-Myers face off with advanced melanoma combo data

Results from clinical trials in patients with advanced melanoma highlighted the ongoing rivalry between best-selling cancer immunotherapies Keytruda and Opdivo — from Merck and Bristol-Myers Squibb Co., respectively — both presented at ASCO's annual meeting.

AbbVie-Roche drug combo halts blood cancer progression

AbbVie Inc. said a combination treatment with its drug Venclexta and Roche Holding AG's Gazyva showed promise in a phase 3 trial with chronic lymphocytic leukemia.

Takeda drug stops lung cancer growth 7 months into treatment

Takeda Pharmaceutical Company Ltd. said its next-generation, small-molecule tyrosine kinase inhibitor TAK-788 showed promise in a phase 1/2 clinical trial in patients with non-small cell lung cancer.

Ovarian cancer diagnosed, treated earlier after ACA

Women under the age of 65 were more likely to receive an early-stage diagnosis and treatment for ovarian cancer after the Affordable Care Act became effective, according to a study released at the 2019 Annual Meeting of the American Society of Clinical Oncology.

Essential Healthcare is a weekly collection of critical developments across the pharmaceutical, biotechnology, healthcare provider, healthcare technology and medical equipment industries that draws on exclusive analysis and value-added content from the Healthcare News team at S&P Global Market Intelligence. Subscribe now to get Essential Healthcare delivered to your inbox every week.