In an expected development, the US Senate on Tuesday (26 June) voted overwhelmingly to approve the Food and Drug Administration Safety and Innovation Act (FDASIA), advancing the bill to the White House where it is expected to receive approval from President Barack Obama in July.
The 92-4 vote followed months of negotiating between the House of Representatives, the Senate, the US Food and Drug Administration (FDA), the pharmaceutical industry, the medical device industry, the generic pharmaceutical industry, patient and consumer groups, and others. After first voting on separate versions of the bill, the House and Senate met in early June 2012 to work out differences between their respective versions before agreeing to amend the Senate's version of the legislation. FDASIA previously passed the House on 18 June, also with overwhelming approval from legislators.
The legislation is as notable for what it contains as for what it leaves out.
The bill contains prominent provisions reauthorizing industry-paid user fees for pharmaceutical and medical devices products. The bill also establishes user fees for generic drug products, increased funding for foreign manufacturing facility inspections, incentives for the development of antibiotic drugs, measures to ease drug shortages and accelerated approval pathways for some products.
A number of popular and controversial provisions did not make it into the bill. A long-debated drug tracking system known as a "track and trace" plan failed to make it into the final bill despite being included in the Senate version of the legislation, as did a separate provision aimed at preventing branded manufacturers from using a Risk Evaluation and Mitigation Strategy (REMS) plan to keep potential generic competitors from obtaining their products.
Broad-based Support and Minor Opposition
Only three Senators ultimately voted against the bill: Sens. Rand Paul (R-KY), Richard Burr (R-NC), Tom Coburn (R-OK) and Bernie Sanders (I-VT). Burr in particular said he was concerned the Senate had rushed through the legislation at the expense of the "track and trace" provisions of the law and had thus missed the best chance to enact the measure.
The pharmaceutical industry trade group PhRMA said in a statement it looks forward to "working with Senators Burr and [Michael] Bennet, as well as other stakeholders in the domestic supply chain, to complete work on track-and-trace legislation this year." PhRMA also praised the bill, saying it anticipates it will "enhance the efficiency of FDA's human drug review program and will help bring safe, effective and innovative medicines to patients in a timely manner."
The medical device trade group AdvaMed was also supportive of the law, saying the law "sets in place measures that should increase the efficiency and predictability of FDA's medical device review process."
In a rare comment on pending legislation, FDA Commissioner Margaret Hamburg put out a statement commending legislators for their efforts to pass the bill. "It takes steady and reliable funding to maintain and support a staff of trained reviewers capable of accomplishing this vital task," explained Hamburg. "We're gratified that Congress agrees."
"Such overwhelming support for FDA user fees is a testament to the important role FDA plays in America's healthcare continuum," added Hamburg.
The legislation is expected to review support from the White House, though the timeframe for it to receive President Obama's signature is still far from certain. In a 17 May statement, the White House indicated it supported the Senate's version of the user fee bill-the same version passed today by the Senate-but has made no further statements on the legislation since that time either for or against the bill.