“We want to be regulated.” That seems to be the theme thus far at the IPEC Regulatory Conference, taking place today and tomorrow in Washington, DC. The morning session opened with IPEC Chair Janeen Skutnik talking about how busy the past year has been for the excipient industry and for IPEC itself. With work being done on pedigrees, functionality, GMPS, and GDPS, excipients are taking on all sorts of new lives.
For instance, Skutnik reported that IPEC is now working to convert all of its guidelines to ANSI standards. Because there is no regulatory enforcement of excipients, this step will at least provide excipient guidelines that a broader public can use and that have been developed via consensus. Also of note, the IPEC Federation is now operational, representing the various regional IPEC organizations such as IPEC–Americas, IPEC–Europe and other IPEC offices that have opened recently, such as IPEC–China (and soon to exist IPEC-India). The mission of IPEC remains the same—to focus on the safety, functionality, and quality of excipients for the pharmaceutial industry—but there will now be one voice to represent those goals.
This morning’s session was largely off the record, featuring talks from a senior health advisor to the Senate HELP Committee and representatives from other administrative and congressional bodies. But the message from the audience was clear—the excipient industry wants to be regulated, they want stronger enforcement. Don’t assume that we’re afraid of extra costs, said former IPEC Chair Dave Schoneker, of Colorcon. If the pharmaceutical excipient industry can make things safer and better for the public by having increased standards and regulations, then they’re willing to take it on. Schoneker also noted that Congress should not assume excipients are less risky because they’re “inactive.” For example, think of how many individuals died from exposure to DEG (going on 900) versus melamine and heparin, he said.
Another speaker focused on the current administration’s goals and how there is more momentum now to secure the pharmaceutical supply chain at the borders. The extra push for technology to create solutions to current problems from the Obama team is also at play. There are multiple proposals in Congress, and with FDA’s (slightly) increased budget and new leadership, pharmaceutical manufacturers (including excipient users, suppliers, and distributors) are in for change in the coming years. But the audience here in Washington seems more than ready to welcome those changes if it means securing the supply chain once and for all.
Of note, this will be the last standalone IPEC regulatory conference. Starting in 2010, the Council is partnering with ExcipientFest to hold a joint conference on excipients, offering similar topics but in a bigger and better way.