BRASELTON, Ga. A lunchtime discussion on managing “REMS and the RFP Process” proved a timely and relevant addition to the one-on-one meetings between providers and manufacturers at the ECRM Specialty Pharmacy meeting, held here last week at the Chateau Elan resort.
High-profile drug safety issues such as those caused by Vioxx and Tysabri in recent years, has caused Congress to pay closer to scrutiny to FDA and the process by which it allows new drugs to come to market, resulting in the Food and Drug Administration Amendment Act of 2007. One key provision. Risk Management and Mitigation Strategies, or REMS, is becoming a major part of the regulatory approval process, explained D2 Pharma Consulting principal Dean Earhardt.
Subject to FDA review, the REMS requirement “may range from a simple medication guide to a communication plan to Elements to Assure Safe Use (ETASU),” D2 noted in a company white paper, “REMS Challenges and Real World Solutions,” which was authored by Earhardt in conjunction with D2 partner, Dan Steiber. “These more comprehensive REMS programs with ETASU may include such components as a patient registry, physician and pharmacy certification, to name a few.”
For specialty pharmacy/biotech manufacturers some sort of REMS requirement will likely prove the rule rather than the exception in any new drug approval process. However, FDA has the authority to require a REMS program for any NDA it reviews, and moreover, it can also mandate a REMS requirement post-approval.
In all, more than 100 retailers and suppliers attended the two-day meeting, marking a respectable showing for one of the newest meetings on the ECRM calendar—and a most productive one, attendees told Drug Store News.
“In the span of two days we were about to have over two dozen meetings,” noted David Suchanek, SVP Biotechnology and Specialty Services, D2 Pharma Consulting. “It would have taken three months and thousands of dollars in travel to organize and attain the meetings that we had in a 48 hour period.”
Suchanek co-presented with Earhardt during the session on REMS.