Knowledgeable Marketing Guidance
We've "been there, done that." DuVal & Associates regularly advises clients on issues relating to the labeling, advertising, and promotion of FDA-regulated products, including pharmaceuticals and biologics, medical devices, dietary supplements, among others. Our attorneys have worked in industry. We understand what it takes to launch new products, and develop prescriber and patient advertising campaigns using the latest technological advances, such as websites, social media, paid search, and micro blogging, in a compliant fashion that considers current FDA thinking.
The three "buckets" of on-label promotion, communication, and off-label dissemination. We help clients understand the distinction between on-label promotion and informally safe-harbored "communications," and about off-label dissemination. We appreciate the nuanced complexities of these areas, and we constantly glean FDA's enforcement stance from many guidance documents, podium policy, warning letters and FDA/industry First Amendment lawsuits (Washington Legal Foundation, IMS, Caronia, Amarin and Pacira) which we analyze to advise our clients. We help you understand what can be said about a product under investigation and/or pre-approval. We understand FDA's position on direct-to-consumer advertising, and social media, as well as help-seeking, institutional, and reminder ads.
Our promotional counsel is all-encompassing. Our promotional counsel is not limited to just covering the advertising and promotional regulations and guidance under the Food, Drug, and Cosmetic Act. We have years of experience and deep insight into how to successfully navigate and comply with the Anti-Kickback Statute, the Physician Payments Sunshine Act, False Claims Act, and HIPAA.
You tell us what you would like to do, and we'll help get you there creatively and lawfully. We are often assigned to lay out the promotional enforcement landscape for clients and then whiteboard promotional possibilities with them, helping clients be appropriately aggressive, yet compliant.
Routine assignments include:
- Laying out the promotional enforcement landscape and helping you whiteboard strategic promotional plans – We understand the confluence of the advertising and promotional regulations and guidance along with the Anti-kickback Statute, False Claims Act (reimbursement), the Sunshine Act and state law corollaries to them. We will help you put together strategies that will help your company be appropriately aggressive, yet complaint, and within the bounds of cultural risk-taking that suits your firm.
- Sitting on your promotional review team – We review and suggest changes for labeling, advertising, promotional materials and websites, e.g., Facebook, Twitter, LinkedIn, and YouTube.
- Direct-to-consumer and other unique forms of advertising – We help you evaluate and edit launch materials, institutional, help-seeking and reminder ads, direct-to-consumer advertisements and educational materials, paid television advertising, and press releases.
- We understand how compliance fits in to the overall promotional scheme – We will work with company leadership on developing compliant promotional programs and campaigns. We know the company must sell product to be successful. WE help to balance compliance with the exigencies of sales and marketing.
- Help you navigate the Anti-kickback Statute and Sunshine Act – We provide counsel on the implications of the Anti-kickback Statute and the Physician Payments Sunshine Act for remunerative relationships with health care providers, such as referral dinners, co-marketing, speaker’s bureaus, discounts, rebates, free goods and evaluation units, rebates and other off-invoice price concessions, etc.
- Avoid False Claims Act (reimbursement) exposure – We counsel on appropriate reimbursement claims under the False Claims Act in sales collateral materials, lap top pro formas, and other reimbursement tools.
- Compliance with HIPAA – We provide practical guidance on the application of HIPAA to a medical device manufacturer and their sales organization to help them know among other things when they have to sign a business associate agreement or not.