Would Washington’s FDA Fix Cure the Patients or the Drug Industry?

This might seem to be a rough political patch for the pharmaceutical and medical device industries. The exponential price increases of several drugs have brought scrutiny to the overall rise in drug costs and have prompted several 2016 candidates, most notably Hillary Clinton, to vow action to rein in the industry. Meanwhile, thousands of complaints are pouring into the Food and Drug Administration about a contraceptive implant made by Bayer.

In Congress, however, things are looking better for the manufacturers. Legislation is advancing that would speed up the FDA’s approval process for medications and medical devices, offering a rare example of how major initiatives can get traction even in today’s gridlocked Washington.

The industry has mounted a major lobbying and public relations push for the 21st Century Cures Act. The bill, in turn, has garnered an unusually broad range of support, ranging from Republican lawmakers and conservative think tanks to the White House, patient advocacy groups, Democrats and nonprofit organizations that are typically leery of deregulatory efforts by industry. One reason: Lawmakers softened up the usual opponents of looser rules with a big carrot — billions of dollars in new federal medical research funding for the National Institutes of Health. After years of austerity, that money is awfully difficult to turn down.

But the enthusiasts have left a small band of critics warning that bipartisan consensus does not necessarily affirm the bill’s worth. Far from showing that Washington can still get big things done, they say, it shows how a lobby can blow past skeptics if the pot of resources is sweet enough. They maintain that the bill, which easily passed the House in July and has a counterpart soon to be introduced in the Senate, hasn’t received the scrutiny that such sweeping legislation deserves. […]

The list of entities lobbying on the bill now runs to about 1,800 quarterly entries in the Senate’s lobbying database, with more than 1,100 lobbyists registered as working on it, which is staggering even by the standards of Washington. And what has been so beneficial for the legislation is that the vast majority of those entities are not companies or trade associations, which are motivated by bottom-line demands, but patient groups and universities, which have a far more neutral sheen.

“Members of Congress who wouldn’t be responsive to pharma’s lobbying did respond to universities’ lobbying or to patients’ lobbying,” said Diana Zuckerman, president of the National Center for Health Research, an advocacy group that has spoken out against the legislation. “It was a perfect storm of lobbying.”

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