Do you want to save $300?

I have been invited to speak at the American Conference Institute's FDA Boot Camp in Boston on September 18-19. I'll be talking about ad/promo regulations in the master class following the main conference.

ACI informed me that I'm able to offer a $300 discount to anyone interested in attending the conference, and not just the master class.

The conference itself is geared toward lawyers who are new to Food and Drug Administration law and regulation.

I co-presented with Alan Bennett of Ropes & Gray last year, and it was a great experience.

ACI events tend to be smaller sessions that really permit the attendees to ask questions and get engaged with the speaker more than some of the larger events. And for attorneys, this event also comes with CLE credit (details at the site below).

Here's a link to the program:

So, if you are interested, or if a friend is interested, please send me a message, and I'll send you the details to take advantage of the discount.

New OIG Guidance on PAP Programs

The Office of the Inspector General has released a supplemental bulletin alerting pharmaceutical manufacturers that third-party Patient Assistance Programs (PAPs) that are run by independent charities might be subject to prosecution under fraud and anti-kickback statutes.

Quoting from the press release on the OIG website:
"OIG is mindful of the importance of helping financially needy beneficiaries of Federal programs receive needed medical care. Independent charities can play an important role in advancing this goal. If, however, a charity acts as a conduit for a drug manufacturer to induce the prescription of its drugs, Federal health care programs and their beneficiaries are put at risk. OIG will therefore closely scrutinize PAPs that do not appear sufficiently independent from their donors," said Inspector General Daniel R. Levinson.  
You can read the full release and access the bulletin from these links:

How LinkedIn Changed My Job

Recently, I was invited to participate as a faculty member for the University of California, San Francisco's program on drug regulatory sciences, as I mentioned in this post.

I did not immediately update my LinkedIn profile to note my affiliation because I wanted to wait to see whether this would be an ongoing engagement or a one-time event. I was invited back, and it appears this will be an ongoing position. So, I updated my LinkedIn profile accordingly.*

Many people congratulated me on the affiliation, but by the second one, I noticed that LinkedIn had made it seem that I had changed jobs by changing the headline on my profile and posting the new affiliation above my position with Digitas Health LifeBrands.

I updated my profile again to change my headline back, and posted a corrective message to the congratulations stream indicating that I am still with DH LifeBrands, but since then I have received three new congratulatory messages talking about missing me from Philadelphia and hoping to catch up in San Francisco.

There has not been any harm done, and I'll simply have to reach out to some people individually to resolve the confusion, but it is an object lesson on the need to understand the intricacies of social media because minor errors can be difficult to correct, even for experienced users.

*Note that I am happy to connect via LinkedIn, but you have to tell me who you are, and how we know each other. I connect with people I meet or have an interaction with, but I do not accept blind invites from people I don't know. Just tell me you follow my blog to get a response.

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.

Twitter Redesign

Twitter has announced a redesign that will be mandatory for all users as of May 28.

My colleague Sam Arabolu put together a primer on the changes and how it will affect pharma marketers in particular. You can access the primer here:

Biosimilarity Guidance Available

The FDA released a new draft guidance on the clinical pharmacology data needed to support  biosimilarity. Here's the guidance, and here's the announcement in the Federal Register.

Temple Ad/Promo Class

A friend of mine (Preeti Pinto) is teaching an ad/promo class in Temple's QA/RA program this summer. Here's the link:

RAPS Philadelphia Chapter Meeting

The May 19 meeting of the Philadelphia chapter of Regulatory Affairs Professionals Society will feature Paul Brooks of BSI, speaking about the upcoming changes to the EU medical device regulations.
We have settled on the Primavera Pizza Kitchen as our host location.
I hope you'll join us.
Here's the registration page.

FTC Reminder

The FDA isn't the only governmental regulatory body we need to keep in mind as we develop promotional materials and health communications.
Yesterday, the Federal Trade Commission (FTC) gave the industry a timely reminder.

In this story, the FTC pointed out that many health and fitness apps were not abiding by good privacy practices.

Industry will be much better served by policing itself on these issues and developing all of their technology-driven communications to respect users' privacy rights rather than misbehaving and forcing the federal government to step in to rectify the situation after the fact.

Respect for user's privacy should be central to all of our communications platforms.

h/t @pantello

April Travels Bring May Posts

I spent much of last month on the road, including a presentation at the DTC National conference, a stint lecturing in the University of California, San Francisco, a few client presentations, and a virtual conference for Regulatory Affairs Professionals Society.

As a result, I haven't been posting much, but there are two new presentations available on my SlideShare site.

You can access them from the link in the right rail. I hope you enjoy them.
Let me know what you think.