President Obama Paid Special Attention To Medical Innovation During His State Of The Union Address last week when he highlighted a "precision medicine initiative" aimed at finding cures for cancer, diabetes, and other diseases. Some have linked this announcement to the 21st Century Cures initiative, legislation under development in the House Energy and Commerce Committee, designed to revamp how medical research and drugs are approved. Lawmakers released a 400-page discussion draft for the "21st Century Cures Act" alongside a more condensed section-by-section analysis and a press release calling for continued feedback.
In addition to new therapies, the President and the Congress continue to address the issue of antibiotic resistance. Four months ago, the Obama administration released its National Plan for Combating Antibiotic Resistance, calling for the development of new antibiotics and preventing the spread of drug-resistant bacteria. This week, the White House announced that the President's proposed FY2016 budget would double the amount of federal funding for combating and preventing antibiotic resistance, increasing to more than $1.2 billion. On the legislative side, two senators recently reintroduced legislation to speed up regulatory approval for new treatments, citing the need for new drugs to fight antibiotic-resistant bacteria. The Promise for Antibiotics and Therapeutics for Health Act (the "PATH Act") would create an accelerated approval process for treatments that address unmet needs for serious or life-threatening conditions. Although there is general support for the President's plan and the PATH Act, consumer advocates want more controls on antibiotic use in food animals to prevent antibiotic resistance.
The medical device tax is another issue that Congress, and likely the President, will revisit this year. As in the previous two Congresses, both houses have introduced legislation to repeal the medical device tax. The House has twice before passed such legislation, but similar measures were defeated in the Democratic-controlled Senate. With Republicans gaining control of the Senate, opponents of the tax are more optimistic, and some have predicted a bill repealing the tax could pass both chambers as soon as late March 2015. The President, however, has said he would veto the bill because it undermines the Affordable Care Act, his administration's signature law. In an interesting twist, the nonpartisan Congressional Research Service issued a report challenging the medical device industry's claims that the tax would have significant economic impacts, including moving production overseas and costing jobs. However, lawmakers and advocates for repealing the tax remain undeterred.
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