On Episode 1 Lanton Law speaks with STACK CEO Jonathan Ogurchak about privacy trends, healthcare efficiencies using SAAS and whether healthcare is ready for tech disruption.
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The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
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The Consumer Financial Protection Bureau (CFPB) issued an announcement that it is “invoking a largely unused legal provision to examine nonbank financial companies that pose risks to consumers. The CFPB believes that utilizing this dormant authority will help protect consumers and level the playing field between banks and nonbanks. The CFPB is also seeking public comments on a procedural rule to make this process more transparent.”
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Massachusetts Attorney General Healey has agreed to Optum’s Atrius Health acquisition for a price of $236 million. With this Optum has taken another step in its acquisition of Massachusetts’ largest independent physician organization.
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In an interview with Pharmacy Times, Ron Lanton, JD, principal at Lanton Law, discussed the recent Johnson & Johnson legal settlement in Texas to resolve opioid claims. Lanton said this decision could be significant but working with prescribers is an essential step to shifting the opioid epidemic.
To access the video and the entire text of the interview click here.
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We have a new micro webinar on the corporate practice of medicine.
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Check out our micro webinar on the upcoming FTC comment and period on pharmacy benefit managers.
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The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.”
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In the first episode of Pharmacy Focus: Oncology Edition, the Times spoke with Ron Lanton, JD, principal at Lanton Law. Although it is still too early to know how the program differs from private-sector efforts to improve cancer treatments, Lanton said the program has some interesting goals and approaches.
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The U.S. House has passed the Marijuana Opportunity Reinvestment and Expungement Act otherwise known as the MORE Act. The proposed bill removes marijuana from the list of scheduled substances under the Controlled Substances Act and eliminates criminal penalties for an individual who manufactures, distributes, or possesses marijuana.
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President Biden has invoked the Defense Production Act as a means to increase mineral production that is used to manufacture electric vehicle batteries.
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According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
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At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise.
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On March 15, 2022 President Biden signed the Consolidated Appropriations Act of 2022 into law. The announcement can be viewed here. This $1.5 trillion omnibus appropriations bill is important as there are several provisions applicable to hospitals and health systems contained within; namely touching on issues such as 340B eligibility and telehealth.
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