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 Bloomberg BNA Medical Devices Law & Industry Report, in “Industry Lawyer Urges FDA to Release Combo Product Final Rule,” by Michael Williamson.
Following is an excerpt:
The proposed version of the rule was issued in 2009. There are two main reasons why it’s important that the Food and Drug Administration issue the final rule as quickly as possible, Bradley Merrill Thompson, the general counsel for the Combination Product Coalition (CPC), said.
First, in the absence of a final rule, the CPC has heard that some FDA inspectors have been using inconsistent criteria for inspections of complaint handling and reporting issues, according to Thompson.
“Second, several companies have begun developing and building (or are planning to develop or build in the near future) reporting systems based on their ‘best guess’ of what the final regulations will look like,” Thompson told Bloomberg BNA. However, developing combination products without the final rule creates “significant problems” for manufacturers, he said.