Category: Sales & Marketing

Revisions to New Jersey Prescriber Gift Ban Law Proposed – Comments Due October 5th

Revisions to the Limitations on and Obligations Associated with Prescriber Acceptance of Compensation from Pharmaceutical Manufacturers law, N.J.A.C. 13:45J-1.1 et seq. (NJ Gift Ban Law), have been proposed by the New Jersey Attorney General. The NJ Gift Ban Law, originally adopted effective January 16, 2018 and previously discussed on this blog, drew […]

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 […]

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 […]

OIG Advisory Opinion Approves Ostomy Supply Distributor to Provide Free Product Samples

On Monday, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-02 regarding an arrangement in which the Requestor who distributes and sells, but does not manufacture, certain ostomy products (Products) provides a limited number of free Product samples to patients and contracts with a third party (Contractor) to […]

Nevada Releases Procedures for Pharmaceutical Representative Registration

The Nevada Department of Health and Human Services (DHHS) recently released procedures related to pharmaceutical representative registration in response to Nevada SB 539. An overview of Nevada SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry, is available here. The procedures require registration by pharmaceutical representatives that physically […]

Comments to Draft Chicago Pharmaceutical Sales Representative License Rules Due April 2, 2017

As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and the Commissioner of the Chicago Department of Business Affairs and Consumer Protection (BACP) recently released […]

Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency Reporting

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days […]