Category: Healthcare

Off-Label Use Gets Congressional Hearing

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug Administration (FDA) can provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data […]

User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization.  The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in […]

Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit Organizations

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in adopting legislation aimed at addressing pharmaceutical price increases and other recent industry concerns. Diabetes Drug Pricing Reports February […]

Texas Becomes 50th State to Recognize Physician-Patient Relationship Established through Telemedicine

On May 27, Texas Governor Greg Abbott signed S.B. 1107 (the “Bill”), making Texas the last state in the nation to allow for the establishment of a physician-patient relationship through a virtual visit. The recently passed legislation eases the regulations surrounding the delivery of telemedicine services in Texas, and has […]

FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding its planned research titled, “Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The FDA explained that direct-to-consumer […]

Maryland Enacts Landmark Drug Price Gouging Legislation; Nevada Governor Considers Drug Pricing Bill

Maryland became the first state to enact legislation that outlaws “price gouging” in the generic drug market. H.B. 631, enacted on May 27, 2017 (the “Act”), has two components: (1) a prohibition on price gouging; and (2) a mechanism for reporting, investigating, and penalizing price gouging in the state’s Medicaid […]

House Passes AHCA; Senate Says “Not So Fast”

Last week, the House of Representatives passed the American Health Care Act (AHCA) by a razor-thin margin of 217-213. No Democrats supported the bill and 20 Republicans voted against it. Recall in March, the House was forced to pull AHCA Version 1.0 from the floor because leaders lacked the necessary […]