Hope runs high that FDA user fee bill will escape congressional acrimony
Our perpetually divided Congress hasn't yet passed a bill that would cover medical device and drug user fee agreements once the existing 5-year law expires in September. But there are some encouraging signs that legislators are trying to avoid roadblocks for the measure designed to fund a big chunk of both industries' regulatory reviews.
One risk has been that the bill would be saddled with Republican amendments meant to sap money from or lead to the repeal of the national healthcare reform law, which passed in 2010. But as Politico reports, congressional leaders are working hard to avoid these (or any other) obstacles. In fact, lawmakers from both parties are pushing hard to approve the new legislation before June, when the U.S. Supreme Court is expected to rule on the healthcare law, as the story explains.
Why is there such an urgency to get this done? John Rother, president of the National Coalition on Health Care, tells Politico "the combined power of the industries regulated by the FDA would not be something anyone would want to tangle with when it comes to getting this legislation done."
Politico notes that last month's markup of the bill by the Senate Health, Education, Labor and Pensions Committee was unusually (for these times, at least) absent of any major conflict. The committee backed the bill almost unanimously. House leaders have been a bit more contentious, but staffers from both sides of the aisle still expect the House Energy and Commerce Committee's Subcommittee on Health to complete a markup of a bipartisan agreement by Tuesday. At that point, the full committee will take it up the measure. Sources told Politico that they hope that the bill will be moved to the House floor under a suspension of rules, thus speeding the process along.
And with the looming Supreme Court decision on the law and national elections this fall, there has been no sign yet of amendments for the FDA legislation, something that could stop, or at least slow it down. Even if amendments surface, some observers believe that they will be relatively minor and won't threaten the bill because its disruption would harm many powerful companies seeking to get products approved and ramped up for commercial sale.
- here's the Politico story