Politics

21st Century Cures Act supporters crush meager House opposition, head to a final showdown in the Senate

Critics of the 21st Century Cures Act in the House didn’t have a prayer in their fight against the bill. In a rare show of bipartisan support that will likely prove hard to stare down in the Senate, Democrats and Republicans in the lame-duck session voted in favor of the revised legislation by a vote of 392 to 26.

Supporters called it a win-win for patients and biopharma, promising to speed drugs even faster through the regulatory process while funneling billions to support new research initiatives like the cancer moonshot, spearheaded by outgoing vice president Joe Biden.

Senator Elizabeth Warren

Senator Elizabeth Warren

Opponents, who will now rally around Senator Elizabeth Warren in a last-ditch stand to stop the bill, see it as an early Christmas present for the industry, festooned with gifts that include lowered standards on drug and device approvals, including a “real world evidence” procedure that would substitute summaries of observational data in place of a complete read out on the clinical trial data — the gold standard in drug development.

Yale’s Joseph Ross told Vox: “This raises all sorts of red flags to me. You don’t know 100 percent how well something works unless you’re studying it in a trial.”

There’s also some bipartisan opposition to the bill that could be telling next week. Senator Charles Grassley, R-Iowa, joined Warren in opposing a move to weaken the Sunshine Act, that shines a bright spotlight on industry payments to the same doctors who prescribe their medicines.

The wide support for the bill, though, is reminiscent of the collective efforts in the House to back extended market protections for biologics, which highlighted Jim Greenwood’s tenure at the head of BIO.

After slowly pacing its way through the committee process for more than two years, though, the bill has passed through the hands of more than 1,400 lobbyists and been signed off on by leaders in both parties. And now its speeding to a final confrontation in the next few days, with plenty of momentum behind its supporters.


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RAPS Regulatory Convergence 2017