'We’ve worked on this bill for 18 months,’ Committee Chairman Tom Harkin said. | John Shinkle/POLITICO Senate passes FDA user fee bill

Welcome to an alternate universe in Washington.

With little bickering and no effort to repeal the Obama administration’s health reform law, the Senate passed the massive Food and Drug Administration Safety and Innovation Act on Thursday well ahead of schedule. The vote was 96-1. Sen. Bernie Sanders (I-Vt.) was the only no vote.


The $6.4 billion, five-year reauthorization of FDA-industry user fee agreements partially funds the agency’s review of drugs and medical devices, which would have expired at the end of September without action. Previous user fee authorizations have been contentious affairs. But notwithstanding the election-year and health care politics that dominate Congress, the bill sailed through with hardly a complaint.

In part, that’s because it’s the No. 1 priority for the pharmaceutical and medical device industries. And in part, it’s because legislators on both sides have had a lot of input for a long time.

“We’ve worked on this bill for 18 months,” Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa) said repeatedly Thursday as he and ranking member Mike Enzi (R-Wyo.) refereed the mostly cordial debate. The two led opposition to all of the amendments that came up for a vote, and all were defeated.

That includes two that were strongly opposed by the pharmaceutical industry — and caused the only sparks in the Senate debate.

Sen. John McCain (R-Ariz.) gave a fierce speech for his amendment to allow Americans to import drugs from approved Canadian pharmacies. “In a normal world, this would require a voice vote,” McCain said just before the vote. “But what we’re about to see is the incredible influence of special interests here, particularly [the Pharmaceutical Manufacturers Association].”

Sen. Robert Menendez (D-N.J.) countered that it’s not about the special interests. “It’s about the health and security of the American people, which is why time after time the Senate” has rejected it, Menendez said.

As expected, the McCain amendment failed, 43-54.

Sanders got a vote on his amendment to take away exclusive marketing rights from drugmakers if a company is found to be at fault for fraud involving a particular drug. But the measure failed overwhelmingly, 9-88.

“Almost every drug company in this country” is perpetrating fraud, Sanders said just before the vote. “They’re ripping off Medicare; they’re ripping off Medicaid; and they’re ripping off the American consumer.”

Enzi said the amendment was too broad, allowing exclusivity rights to be revoked for even relatively minor offenses, including misdemeanors.

The speed of the passage was the cause of amazement for onlookers accustomed to the usual congressional gridlock.

“I haven’t seen anything move this fast in a long time,” said Lisa Swirsky, a senior policy analyst at Consumers Union. “Congress is actually working. It’s kind of like you learned about it in high school.”

But speed aside, consumer advocates have mixed feelings about the bill that emerged from the Senate and a very similar version that the House is expected to pick up on Wednesday.

“If you look back at what we saw in the House in December, you know this could have been a lot worse,” Swirsky said. But she added that she was “deeply disappointed” that several provisions consumer groups were pursuing to toughen FDA’s premarket review of medical devices did not make it into the bill. “I would say it’s bittersweet but mostly bitter.”

House and Senate leaders have said the goal is to finish the bill and deliver it to President Barack Obama by early July.

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