Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Administrative Conference of the United States’ draft report, “Federal Agency Guidance: An Institutional Perspective,” by Nicholas R. Parrillo.
(Note: This report is under consideration by the Judicial Review Committee and may be subject to change. For more information on the Agency Guidance project, please visit ACUS.gov.)
Following is an excerpt:
In the world of FDA enforcement, Bradley Merrill Thompson, who has been counsel to trade associations dealing with FDA, urged that FDA should provide more guidance on the obligations of medical device makers. As things stand, he explained, a company can obtain guidance from FDA in the form of a confidential letter that takes about two or three months to get, but the letter has the effect of locking the company in to whatever facts the company provided in soliciting the letter. The development of the product can later get “tied up in knots” because the company does not want to take the risk of departing from the letter’s specifics (as the letter is not necessarily applicable to any other fact pattern). More general, less fact-bound guidance would address this difficulty. In the absence of more general guidance, a company not wanting to commit itself to a particular fact pattern in an FDA letter must seek (in a typical case) an opinion from outside counsel that puts together “small and remote pieces of the puzzle,” including FDA official speeches, reports to Congress, and enforcement patterns (though there is not a complete public record of these), and does effectively a risk assessment of the product seeking to imitate what FDA would do. Even with all this material, it can be difficult to provide a clear answer.
