Bradley Merrill Thompson and James A. Boiani, Members of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, were quoted in FDA Week, in “Attorneys Question Usefulness of New Combo Products Pre-RFD Process,” by Nicholas Florko.
Following is an excerpt:
One industry attorney worried the new process would replace the existing practice of calling OCP staff for informal guidance, but maintains that if the two coexist, there could be benefits for manufacturers.
"If this pre-RFD process will replace the current option for informal questions, I believe we've lost something that was working well," wrote Bradley Merrill Thompson, attorney at Epstein, Becker & Green, in a statement to Inside Health Policy. "But if it's simply another option, it could be quite useful in some specific situations."
Thompson also questioned if it would be in the best interest for industry to enter the new process, instead of going through the formal RFD process.
"Frankly, industry needs to assume that they will likely only get one bite at the apple," wrote Thompson. "If a company receives an answer it doesn't like in response to the pre-RFP process, it is unlikely that FDA would change its view in a subsequent RFP proceeding. So a company would be much better off making its best case supported by data and precedent right from the get-go if the company is going to follow either of these two formal procedures."
FDA is missing the bigger picture when looking at RFDs, according to James A. Boiani, attorney at Epstein, Becker & Green.
"The bigger picture issue is that there are other, more pressing issues with the RFD process to fix, wrote Boiani in a statement to IHP. "For example, unlike most decisions at FDA, an appeal of an RFD decision has no time limit."
