Coming Soon: FDA’s Final Guidance on the Use of Social Media to Advertise Drugs and Biologics

By no later than July 2014, as mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA must issue final social media advertising guidance to industry. Draft guidance: was provided in January 2014 (and comments from the public relating to same closed in April 2014).

Creators of social media advertising for prescription drugs and biologics must have in place robust Internet advertising policies and monitoring processes, particularly since the soon-to-be-issued final guidance will no doubt add other compliance responsibilities not covered by the draft guidance.

The draft guidance makes clear that content relating to social media advertising or

Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling.

Are Patent Trolls (Companies that buy patents to make money by licensing and suing) Acting as “Racketeers?”

Cisco Systems has filed suit against Innovatio IP Ventures (a “patent troll” or “non-practicing entity”), claiming that Innovatio’s tactics of notifying Cisco customers (of using technology that doesn’t belong to Cisco or that Cisco has a right to use) is “misleading, fraudulent and unlawful.”

Startup Act 2.0 Bill Would Provide New US Visa for Entrepreneurs

A foreign entrepreneur who wishes to stay in the US may be able to if legislation to change immigration laws in the US is passed by Congress.

As currently worded, the Startup Act of 2.0, if passed, would allow for a total of 75,000 entrepreneurs to stay if he/she can raise $100,000 in capital and hire two American workers in the first year of the visa term.

Do Unpaid Interns at Your Company or Organization Meet the Definition of Unpaid Intern?

An unpaid intern must perform activities that are akin to a workplace educational opportunity.

The US Department of Labor’s Wage and Hour Division has 6 essential factors that must be met for an unpaid intern to be exempt from being paid.

1. The internship is similar to training that would be given in an educational environment.

2. The experience is for the benefit of the intern.

3. The intern does not displace regular employees, but works under close supervision of existing staff.

4. The employer derives no immediate advantage from the activities of the intern, and, on occasion, its operations may actually be impeded by such activities.

5. The intern in not necessarily entitled to a job at the conclusion of the internship.



Victims of Hurricane Sandy Who are Jarjour | Legal Clients & Friends Receive Guidance by Phone (at no charge) for Next 10 Days

Message from Jarjour | Legal for Hurricane Sandy Victims

We send our concern and best wishes to those of our East Coast clients, colleagues and friends who were in the destructive path of Hurricane Sandy.

We know the storm damaged some of your homes and/or businesses and that many are still without power.

Please let us know if there’s anything we can do to help you during this difficult time.

During the next 10 business days, Ms. Jarjour and team are helping clients and friends of the firm by answering questions and providing direction (via telephone) gratis.

The number to call during business hours is: