FACT SHEET: FDA Approval
PRE APPROVAL: Preparing the Marketplace
The Role of Education
Preparing the marketplace for the entry of a new drug or device is a process that begins in a product's infancy, particularly during Phase II clinical trials. This is the period in which misperceptions about a disease can be clarified, low awareness of the condition can be boosted, and issues with current treatment options can be explored - all with the goal of readying the market for the introduction of the new therapy. MCS manages pre-approval communications, not only for products entering crowded therapeutic areas, but also for those charting new territories. These activities include:
- Strategic market positioning
- Identifying key and emerging opinion leaders
- Media education
- Third-party relationship building
- Medical meeting/ data support communications
- Issues management
- FDA relations
MCS has managed pre-approval communications for products in nearly every therapeutic category, from a potential cure for the common cold to the first pill for gum disease. During this pre-approval phase, MCS has elevated the profile of these agents and their companies through various creative, strategic communications initiatives, which have resulted in coverage in CNN Headline News, ABC World News Tonight, The Wall Street Journal, Fortune, USA Today and Woman's Day, to name a few.
FDA ADVISORY COMMITTEE HEARINGS: A Critical Time for Communications
MCS has supported clients at more than 15 advisory committee hearings. This experience has taught us that the FDA committee meeting is the single best opportunity to profile the data supporting our clients' products. This is accomplished through close partnership with our clients to prepare for the meeting, including media training for investigators and company spokespersons and developing extensive variations of press materials to cover every possible outcome.
FDA APPROVAL: Introducing a New Product to the World
MCS has managed communications for more than 30 FDA approvals, ranging from introducing the first agent in a completely new therapeutic class to announcing line extensions for mature products. The major challenge is one of timing: coordinating complex, multi-faceted approval announcement campaigns with the clients' important, last-minute negotiations with the FDA. MCS strives to generate accurate and in-depth television, radio, newspaper, online and medical trade media coverage for every client's FDA approval announcement, resulting in millions of people worldwide learning of a new treatment in a matter of days.
- In 2003, MCS supported the approval of ImClone Systems' and Bristol-Myers Squibb's Erbitux™ for the treatment of advanced metastatic colorectal cancer. Our video news release, reaching nearly 15 million viewers, resulted in coverage on NBC's Today Show, Lester Holt Live, Bloomberg News, and CNN.
- Additionally, MCS also developed and executed a strategic media campaign in support of the approval and launch, in early 2006, of Warner Chilcott's psoriasis treatment Taclonex®. A national media campaign that reached over 16 million was complemented by grassroots efforts, which resulted in front-page articles in local newspapers detailing patients' success with the treatment.
