Preparing the Market for a New Drug with an Effective ‘Medical Affairs Launch
[/b]
Gary Tyson and Kuyler Doyle, Campbell Alliance
Medical Affairs is growing into an increasingly critical function in today’s biopharmaceutical industry. Access challenges are limiting contact between sales representatives and physicians at a time when therapeutic areas are becoming increasingly crowded. Further, reimbursement policies from global payers are exerting greater influence on prescribing behaviors, leading companies to shift some of their focus from physicians to managed care organizations.
There are risks to how deeply Medical Affairs is involved in launch activities. FDA guidance on permissible activity is unspecific. The primary precaution to take is to have a corporate compliance function, with documented guidelines for internal company practices, and to review Medical Affairs activities against these guidelines. How to put Medical Affairs launch activities into practice will be spelled out here.
The Importance of Medical Affairs at Launch The role of the Medical Affairs (MA) function is to educate stakeholders through the delivery of accurate, complete, and unbiased information that supports a product. MA activities must comply with federal, industry, and company regulatory policy and are not designed to “promote” a product or substitute for Sales and Marketing practices. All materials distributed through the activities of MA should be reviewed for compliance with existing regulatory policies.
How to Carry Out a Medical Affairs Launch Launching a pharmaceutical product requires an immense amount of operational planning, and effective execution of a medical affairs launch is no different. As the medical affairs launch is meant to prepare the market prior to entry, many critical activities must take place well in advance of actual launch. To facilitate planning, the medical affairs launch needs to be coordinated as a set of activities divided by time frames prior to and following market launch. Time frames are divided into Early Market, Pre-Launch, Launch, and Post-Launch phases, each with a set of objectives and activities (See Table).
