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 Bloomberg BNA Health Care Daily Report, in “Pharma/Device Firms Get Clarity on Safety Reports for Combo Products,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, the general counsel for the Combination Product Coalition, an industry group, told Bloomberg BNA in a Dec. 19 e-mail the CPC “is delighted to see the final rule on postmarket safety reporting, or PMSR. Originally published as a draft rule in 2009, companies have been in limbo, waiting for the final rule to make the necessary changes to their internal systems. Now that process of updating systems can proceed in earnest. We believe the public health will be well-served by this modernization.”
“Further, we are generally quite happy with the final rule. Overall, it is substantially improved,” Thompson, who is also a Washington-based attorney with Epstein Becker & Green PC, said.
Thompson said it is clear that the FDA listened to stakeholders and made changes in the final rule that reflected their concerns.
“In particular, the agency helped sort through the different requirements that are applicable to the combination product applicant, versus constituent product applicants. This was a particularly gray area, and the changes the agency made are very helpful,” Thompson said. “In the original proposed rule, there were some ambiguities that might be interpreted as actually expanding the PMSR requirements for constituent product manufacturers and even component suppliers. The final rule puts those issues to rest.”
Thompson also said the FDA “has quite sensibly given industry” 18 months to put new required procedures in the rule in place.
