This has been a particularly active year for congressional legislation with the potential to influence the future shape of medical device businesses (MX May/June 2007, ppage 8). Now that Congress has returned from its summer recess, some of the results of those proposals are coming closer to final passagebut not everything has taken shape in quite the way that medical device companies might have expected.
After months of negotiation with FDA, for instance, industry representatives thought they had created a package that would ensure rapid reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA II). But Congress had other ideaslots of themand tied up the legislation while discussing a wide variety of other topics that came to be attached to it. Although most observers believed that Congress would pass the legislation soon after returning to session, at press time FDA was once again reminding Congress that layoff notices would be sent unless MDUFMA was passed soon.
Shortly after returning from recess, the House of Representatives passed the Patent Reform Act of 2007 (H.R. 1908), which includes a number of provisions opposed by life sciences companies. Device industry associations were quick to urge the Senate to delay work on its version of the legislation until it could be repaired through industry-friendly amendments.
As indicated by the participants in this issue's roundtable discussion, "Medtech's Outlook in Regulatory Affairs" (p.44), not every piece of legislation proposed this year has yet found its final form. There is still ample opportunity for device company leaders to help improve public policy by making their voices heardindividually and collectively.
Developing better legislation today will pay dividends by making it easier for federal agencies to create good regulations that implement the will of Congressand support medtech industry growth.