2003, Healthcare and Manufacturing

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”.

Manufacturing

Manufacturing Provider IT Healthcare

Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

JUNE 15, 2022

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Improvement, and Modernization Act in 2003.

Hospital

Hospital Government Provider IT

Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation

FDA Law Blog

JULY 12, 2021

Two states have submitted importation plans to FDA for approval, but the rule and the certification were promptly challenged in federal court by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other interest groups. Among the Order’s mandates for DHHS are several relating to prescription drugs.

Supply Chain

Supply Chain Government Insurance Manufacturing

Primary Care Digest

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation

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