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Keeping you afloat amidst the rising sea of regulations

FDA and Duke University to Explore Expanded Use of Real-World Evidence for Drugs in Public Workshop

On September 13, 2017, FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will bring stakeholders to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and decision making. Topics in general will include an update on FDA’s activities to address the use of RWE in regulatory decision and development of a framework for handling challenges related to accepting RWE. Panelists are expected to discuss opportunities to improve data development activities, study designs, and analytical data to create robust RWE.

California State and Local Cannabis Rules Take Different Paths

Over the past month, California has been a veritable hotbed of activity regarding the regulation of cannabis for both medical and adult use. Most notably, on June 27, Governor Jerry Brown signed into law the Medicinal and Adult-Use Cannabis Regulation and Safety Act to harmonize and reconcile the state’s requirements for medical and adult use, which previously imposed different standards based on the cannabis’ use.

Phil English and Byron Dorgan Quotes on Healthcare in Fierce Healthcare Article

Arent Fox former Senator and Congressman, respectively, discussed a newly released report that shows the benefits of group purchasing organizations on the cost of health care. The report is the 11th annual edition from The Healthcare Group Purchasing Industry Initiative (HGPII). Phil English, an Arent Fox Senior Government Relations Advisor, serves as the HGPII national coordinator while Byron Dorgan, an Arent Fox Senior Policy Advisor, is the national co-coordinator.

HOPPS Proposed Rule Recommends Big Changes to 340B Program

The Centers for Medicare & Medicaid Services (CMS) has released its annual proposed update to the hospital outpatient prospective payment system (HOPPS) for calendar year 2018 (the Proposed Rule). The official version of the Proposed Rule will be published in the Federal Register on July 20, 2017, and comments are due on September 11, 2017.

FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Amendments).

45 Hospital and Health Care Executives Outline the Hospital of the Future

Health Care partner Tom Jeffry, and 44 other health care executives, spoke to Becker’s Hospital Review about the key trends disrupting the traditional hospital and how institutions can prepare for the future. “Looking towards the future, hospitals will devote more space and technology to accommodate advances in diagnostics and surgical procedures. New technologies will continue to reduce inpatient admissions as well as the number of days inpatients remain in the hospital.

South Carolina Hospital Settles With OIG Over Alleged EMTALA Violations Involving Psychiatric Emergencies

AnMed Health, a hospital located in South Carolina, recently agreed to pay almost $1.3 million dollars and enter into a settlement agreement with the HHS Office of Inspector General (OIG) to resolve allegations that it violated the Emergency Medical Treat

Bitcoin for Care: Healthcare Hopping on the Blockchain

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

FDA Issues Draft Guidance For Product Identifier Requirements

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Will Opioid Manufacturers Become the Next Big Tobacco?

With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction.