Leaders on both sides of the aisle understand that time is of the essence and that the situation calls for consensus and pragmatism. As House Energy & Commerce Chair Pallone bluntly stated a few weeks ago during a hearing on the mark-up of the House User Fee bill: “t]he problem we face and the reason we want to move so quickly is we don’t want a situation where the FDA has to send out these pink slips [to FDA employees] which they have done before.”
Yesterday, Senator Burr, ranking member on HELP expressed the need to support a bill which has bipartisan backing in an exchange with Senator Bernie Sanders on his proposed amendment addressing re-importation. “I want to tell my colleagues, if you want to kill this bill, do reimportations ... Bernie, you’re entitled to your own opinion, but you’re not entitled to your own set of facts, and just because you speak loudly does not mean what you say is in fact true.” Senator Sanders’ amendment was eventually tabled. The HELP Committee Chair, Senator Murray pointed out that Senator Sanders’ amendment did not have bipartisan support and an earlier amendment to the User Fee bill required the FDA to issue regulations allowing the importation of drugs from Canada.
What was clear: not everyone is getting everything they want in the User Fee bill. Indeed, Senator Burr ultimately voted in committee against the User Fee package. The reasons mentioned in his post-hearing statement pertain to some of the amendments, which in his view, may stifle innovation.
Stay tuned...
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.Back to HCB News
