FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]

FDA Issues First of Four Draft Guidances Related to Patient-Focused Drug Development

Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1), to address how stakeholders can collect and submit patient experience data from patients, caregivers, clinicians and patient advocacy groups for product development and regulatory decision-making. “Patient experience data” is defined as data that is “collected by […]

Two Federal Transparency Bills Introduced in Congress

Two new federal bills have been introduced in Congress related to manufacturer transparency. Senate Bill 2891 (S. 2891), the Fighting the Opioid Epidemic with Sunshine Act of 2018, was recently introduced by Senators Grassley, Brown and Blumenthal. S. 2891 would amend the current Open Payments law to require annual reporting […]

Connecticut and Vermont Latest States to Pass Drug Pricing Transparency Bills

Following on the heels of several other states, including California, Nevada and Oregon, that have enacted drug pricing transparency bills, Connecticut and Vermont are the latest states to join the fray. In Connecticut, Public Act No. 18-41 requires pharmacy benefits managers (PBM), health carriers, and drug manufacturers to report certain information […]

OIG Advisory Opinion Permits Limited Provision of Free Telemedicine Hardware and Services

On May 31, 2018, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-03 regarding an arrangement in which a not-for-profit Federally qualified health center look-alike (Provider) would provide, at no charge, certain information technology-related equipment and services to a County Department of Health health clinic (County Clinic) for […]

***UPDATED*** Senate ‘Right to Try’ Bill Under Consideration in the House of Representatives

***6/8/18 Update*** President Trump signed S. 204, now Public Law No: 115-173, into law on May 30th. ***5/23/18 Update*** The House passed S. 204 on Tuesday in a 250-169 vote in favor of the measure. The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right […]

Two Enacted State Laws Permit Truthful Off-Label Promotion

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]