Lawmakers will likely wait to see what the long-anticipated healthcare-reform legislation package will include before moving on several high-profile bills that, if passed, would significantly affect how medical-device and drug companies develop, market and manufacture their products, healthcare policy experts say.
Hundreds of healthcare-related bills, at least eight of which would affect the medical-products industry, have seen little movement since their introduction to the Senate or House earlier this year. But legislation hawks said that doesnt mean several high-priority bills are stuck and in danger of not being brought to a vote sometime in 2009. If theres any increase in the number of bills in waiting, its because people are really excited about healthcare and people want to get their bills in to be considered as part of healthcare reform, said Ashley Glacel, spokeswoman for the Senate Aging Committee, which has helped draft a number of healthcare bills, including the Physician Payment Sunshine Act and the Nursing Home Transparency and Improvement Act. I know with our staff, a lot of the feeling is if we dont get (legislation) in now, why bother? It could be too late.
Brett Loper, director of government affairs for the Advanced Medical Technology Association, a medical-device lobby group, agreed that reform efforts are driving the pace of movement on a number of bills. The situation on the healthcare reform front is one that comes along once in a generation: Its like the Super Bowl of healthcare. So its logical to think that there will be one bill that affects everything. Its addressing $2.5 trillion in spending a year.
Among the high-profile bills of concern to medical-product manufacturers are the Physician Payment Sunshine Act, which would mandate public disclosure of financial relationships between medical-products companies and healthcare providers; the Medical Device Safety Act of 2009, which would reverse the recent Supreme Court precedent that bars patients from suing manufacturers over damages caused by FDA-approved products; and the Food and Drug Administration Globalization Act of 2009, which would give the FDA greater authority in governing and ensuring the safety of the medical-products supply chain.