Breaking news on off-label promotion and the first amendment

Today the FDA made an announcement. This commenced before the new administration takes office, the FDA released a “memorandum” taking positions on the First Amendment of truthful off-label speech.  However with no particular regulatory significance it may be  an attempt to put agency views on record before the change in administration.   


Six-Week Course on Health Economics and the Health Outcome Liaisons

Understanding the healthcare value dossier. How to accelerate revenues and expand markets.  Virtual or corporate onsite training for MSLs, MA professionals and Medical Writers.  Nascent Medical LLC to offer a Six-week Course on Health Economics and the Health Outcome Liaisons on April 20th.  The course will be led by Jennifer Williams PhD, JD, MBA, RN, MS a veteran leader in the field of Medical Science Liaison and Market Access.  Corporate onsite training available.


The top 5 medical writing mistakes

In my role of reviewing the work of multiple medical writers on a daily basis, I see the complete variety of what’s possible in medical writing. Here are 5 mistakes in medical writing to avoid. I could probably include more than 5, but these are the most common.


How to grow your small medical writing business, what to do and not do

Tuesday, Feb 23, 2016
How to grow your small medical writing business, what to do and not do

In this episode, Emma Hitt Nichols talks to her business partner Chrystie Leonard, co-owner of Nascent Medical. This is the second part of a three-part series. We talk about strategic planning, how to grow a business, and the key metrics that are needed to evaluate the growth of you medical writing business.

In the first part, aired a week ago, we talked about what to look for when buying a business. Next week, in the final third, we’ll talk about getting the business ready for sale.

Selling your medical writing business: What is involved?

Tuesday, Feb 16, 2016
Discussion With Chrystie Leonard about the sale/purchase of Hitt Medical Writing and considerations when selling your medical writing business.

What is involved in selling your medical writing business and getting it ready for sale? What do buyers look for in a business?

Join me as I talk to my business partner Chrystie Leonard about what to look for in a business purchase and also what to consider if you ever want to sell your medical writing business. Maybe as a freelance medical writer, you have never thought about how your business is going to end, but end it must at some point!

Chrystie, who has formerly conducted several mergers and acquisitions transactions in corporate America, bought into Hitt Medical Writing, LLC, in August, 2015, and together we formed Nascent Medical, LLC.

Part Two: Physician Education Using Off-Label Indications

In today’s medical environment there is a two-fold element of risk that affects a medical device company. It is comprised on the one hand by the risk of improper treatment through the agent’s lack of scientific disease state knowledge, and on the other by the medical device company’s fiduciary duty to ensure patient safety, including the facilitation of proper education to the physician of off-label indications. The body of law that regulates the marketing of medical device products in the United States is the Drug and Cosmetic Act, which places a restriction on off-label marketing and advertising. To date, proponents have argued that off-label utilization is a First Amendment right necessary to ensure that patients receive the most effective treatment. Read more about physician education using off-label indications.


When Poor Communication Puts You at Legal Risk

In recent case reviews, off-label promotion of medical devices and pharmaceuticals has been presented as a prime focus for government investigation.  Learn more about how poor communication puts you at legal risk.

This is no doubt due to the two-fold nature of the issues surrounding off-label promotion. In the first place, off-label promotion is an illegal activity that violates federal law; secondly, it places individual employees and the corporations for which they work in jeopardy since infractions for such activities can include incarceration and heavy fines, for the employee as well as the corporate entity. Though the majority of off-label promotion cases have transpired from rather limited causes such as poor communication and inadequate corporate training programs, more than a few categories of off-label marketing complaints were observed during a legal query for this article. These included expansions to unapproved diseases, unapproved disease subtypes, and unapproved drug doses.