A bill the House passed overwhelmingly allowing for accelerated drug approvals is expected to pass the Senate next week despite some lingering opposition in that chamber.
The 21st Century Cures Act sailed through the House Wednesday Nov.30 with overwhelming bipartisan support, building momentum for a vote in the Senate.
The strong support in the Senate is the result of a combination of debate and appeasement. The bill had been stuck in the Senate since last year following the House's blessing on a 344-77 vote. The legislation, which at the time was 352 pages, got sidetracked as both Republicans and Democrats stood their ground on issues they disagreed with while adding on to the bill in a manner which resembled hanging ornaments on a Christmas tree. The bill that passed out of the House yesterday was 996 pages long.
That version was rolled out earlier this week after Democrats allowed changes at the Food and Drug Administration over accelerated approvals but also insisted on inclusion of a funding package for the National Institute of Health and the FDA. Deficit hawks across the aisle said the increased funding was out unless there were provisions stipulating where the cash came from. The money will now come from sale of the oil from Strategic Petroleum Reserve as well as prevention programs contained in the Affordable Care Act.
Moving on a 392-26 vote, the legislation had something for everyone. The Obama administration saw a trio of its research programs funded over the next decade. Vice President Joe Biden's high profile cancer moonshot, the Precision Medicine Initiative and the BRAIN Initiative all will receive support via $4.8 billion earmarked for the National Institute of Health. Another $1 billion is included to fund opioid abuse, which has become a health crisis in states like West Virginia, Kentucky and New Hampshire. And the Food and Drug Administration picks up $500 million that will go in part for additional staffing in the hopes that it can hire talent from the private sector and that the process by which drugs and medical devices are examined can be accelerated.
Provisions laying the groundwork for accelerated drug approvals have found hearty support from pharmaceutical companies as well as patient advocacy groups. But critics of the legislation have charged that making the changes would rob the FDA of its power to oversee drug safety and could endanger the public. They are also concerned the bill will allow the regulator to consider anecdotal evidence and biotech and pharmaceutical companies could present summaries of trial data rather than all of the records.
Some of those critics work in the Senate. Despite the expectation that the bill will receive approval in the Senate, some members have already staked out opposition positions. Dick Durbin, D-Ill., Patty Murray, D-Wash., Bernie Sanders, Vermont independent, and Elizabeth Warren, D-Mass. will vote against legislation. Warren stated on the Senate floor that she would vote against it because she knows "the difference between compromise and extortion."
Sanders was more explicit in his denouncement saying in a statement, "This is a bad bill which should not be passed in its current form. It's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts."
Those who will be casting a yes vote include Senate Majority Leader Mitch McConnell, R-Ky, who said the measure is the most important piece of legislation of 2016. He is likely to be joined by Chuck Grassley, R-Iowa, who once threatened to hold the vote hostage. Grassley was opposed to a provision in the bill shielding doctors from having to disclose publicly any payments from pharma or medical device companies. That rider was yanked from the bill.
While that change might not have made the pharmaceutical sector happy, those interests proved more than capable of looking out for their own well being. Data compiled by the Center for Responsive Politics shows that the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the primary advocacy group of large pharma companies, spent $24.7 million on lobbying over the 21st Century Cures Act.
PhRMA was in good company. All told more than 400 companies, organizations and universities employed almost 1500 lobbyists to chase their agendas and spent about $500 million trying to influence the bill.