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Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There’s also money to help states fight the opioid epidemic, and a boost for mental health care.
But this is Washington, so even this bipartisan bill, which the House of Representatives approved in a landslide and which the Senate is expected to pass Tuesday, leaves a trail of winners and losers.
Winner: Drug companies
More than 1,300 lobbyists roamed the halls of Congress on the Cures Act, and disclosure reports show most of them were working for pharmaceutical companies.
Their work has paid off.
Among other measures, the legislation calls for the use of “data summaries” to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.
They did not get everything they asked for, however. Among the provisions...