The FDA is a Formidable Barrier to Market Entry: An Experienced Guide Can Help

September 10, 2018

Founded in 1906, and now headquartered in Silver Spring, Maryland, the U.S. Food and Drug Administration is the best known and most highly respected healthcare and life sciences regulatory agency in the world.

The FDA’s 15,000 employees are among the most respected, most passionate, and most effective scientists, technicians, and healthcare leaders in the world. They are committed to ensuring that drugs, biologics, and medical devices are both safe and effective at diagnosing and treating patients’ diseases and disorders—and they are committed to ensuring that the good ones get to patients as soon as possible.

The FDA’s requirements, however, present a tall barrier to commercial access to U.S. markets—as well as to foreign markets, since foreign governments often follow the FDA’s lead. But FDA’s employees have discretion to help companies, especially new or small companies, having potentially beneficial new products or technologies, to pass the FDA gauntlet—more easily, on-time, and on-budget.

When facing that gauntlet, therefore, it’s critical that companies maintain positive, transparent, and honest relations with the FDA’s staff. Being at war with the FDA can be fatal – both for a company’s prospects for passage and for patients in need of lifesaving treatments.

The need for positive staff relations is especially important when the sponsor company wants to research and develop, and then launch globally, a novel or challenging (yet promising) product or technology, such as a high-risk/high-reward new product, or a high-cost product.

O’Neill and Associates has partnered with Former FDA Principal Deputy Commissioner John Norris, JD, MBA to provide companies working with the FDA a strategic roadmap for success, known as an FDA Strategic Action Plan (FDA-SAP). Each plan is a unique and provides a detailed list of tasks critical to a company’s success. Negotiating with the FDA without an FDA-SAP can prove challenging, complicated and often ends with disappointment.

As an FDA leader, John Norris served as 2nd-in-command and co-led the agency’s last major reform; a Harvard faculty member, where he taught courses on FDA, regulation, and policy, as well as management, planning, and finance; and a U.S. and global practitioner and leader in regulatory affairs.

 

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