Upcoming Speaking Engagements

The conference season starts up in February, and I have a few engagements (listed in the right hand column as always) coming up. If you follow this blog, then keep in mind that I sometimes have discounts available and will send you the info if you register for updates or send me an email using the form that is also in the right hand column.

First up on Tuesday, February 10 is a webinar I'm delivering with LSTI on the current state of social media guidance. This is an updated version of the webinar that I presented in the fall on the same topic. Since that initial presentation, the comment period has closed on the two social media guidances from last summer (though of course, it's always permitted to send comments even after the docket is closed).

The following week on February 18-19, I'll be leading an exciting panel on leveraging innovative technologies at DIA's Marketing Pharmaceuticals conference. Here's the official description of the conference:

The importance of understanding the complex regulations regarding the marketing of pharmaceuticals, veterinary products, biologics, and medical devices has never been higher. The DIA Marketing Pharmaceuticals 2015 conference will explore drug and device marketing in an evolving environment while serving as a vital forum for all stakeholders involved with the marketing, advertising, and promotion of a wide range of health care products.

Featured Topics:

• Latest enforcement actions and policies issued by the FDA
• Leveraging innovative technologies compliantly
• How other companies are complying with government regulatory requirements
• Best review and approval practices with industry colleagues
• Novel promotional tactics trending in the pharmaceutical industry 
• Emerging issues in the oversight of marketing materials

The panel I'm leading will feature participation by AstraZeneca, J&J, Twitter, and YouTube. Here's the description from the conference webpage:

Consumers and health care professionals rely on the Internet and their mobile devices as essential tools for finding information about health care, medicine, and other treatment options. Makers of prescription products have been lagging behind in the uptake of these tools. This session provides the hands-on experience of some of the people who are leveraging YouTube and Twitter at the time and in the platform that people are using.

You can see the full conference agenda and get registration information here.

The week of February 23 will see me back in DC for the final session of the ACDRS program. This is something I started doing last year and really enjoy because of the intimate classroom setting of working with a group of professionals who have spent more than a year following the development of prescription drugs and studying the regulatory requirements. It's an intense program, and I speak in the final session dedicated to commercialization and (no surprise) the need to understand and leverage new and emerging communication channels.

Before that travel gets started, I'll be attending the local Philadelphia RAPS chapter meeting next week on Thursday, January 29. Gary Buehler from Teva Pharmaceuticals will be speaking about the Citizens Petition process and ways companies use it to delay introduction of generic versions of products. Gary spent nearly 10 years at FDA's office of generic drugs before moving over to Teva four years ago. It should be a great topic, and I hope you'll join.

But whether you're also in the Philadelphia area, will be traveling to one of these events, or joining a webinar remotely, please stop by or drop a line and say hello.

Generics Marketing Receives Another Letter

The Office of Prescription Drug Promotion posted a new letter to its website for the marketing of a generic product (disulfarim tablets) by Alvogen.

Alec Gaffney provides a nice overview of the letter in Regulatory Focus.

Traditionally, generics marketing has not received as much attention from OPDP or its predecessor DDMAC. That has probably been true in large part because there was not as much marketing of generics.

But the post-blockbuster era in pharma meant that lots of drugs with extremely high sales volumes lost their patent exclusivity and generics companies have leapt in to more competitive markets attempting to distinguish themselves and promote their offerings.

FDA has not apparently believed there was any need to provide generics-specific guidance on marketing, as none of the generics guidances provided by the Agency have focused on marketing.

With the recent enforcement actions for generics marketing (in addition to disulfarim, see here, here, and here), and the soon-to-be-approved biosimilars with different possible approvals (interchangeability and biosimilarity), it would be good to hear more from FDA about how it views some of the unique aspects of marketing follow-on products.