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Senate approves FDA overhaul that would provide faster access to generic drugs

By Lisa Mascaro, Tribune Washington Bureau –

WASHINGTON — In a momentary flash of bipartisanship, the Senate approved legislation that would allow Americans speedier access to generic drugs as well as breakthrough treatments for life-threatening diseases as part of a Food and Drug Administration revamping that now heads to the House.

But the comity didn’t last, and the FDA accord was quickly followed by another round of partisan fighting over President Barack Obama’s push to keep student loan interest rates low. On party-line votes, senators blocked Democratic and Republican efforts to prevent interest rates from rising this summer.

The outcome of Thursday’s session sends senators home for the Memorial Day recess with a toolbox for campaign season: On one hand, they can say they’re working together to produce results; on the other, they can spread the blame for the partisan standoff in Congress.

“I wouldn’t make too much of it, but we have had a string of legislative successes that have been bipartisan,” said Sen. Michael Bennet, D-Colo. The FDA bill was approved 96-1, and the House is expected to consider similar legislation next week. “We are going to pass out a very comprehensive set of reforms that are going to be meaningful to patients and also to the bio-science community.”

The FDA bill includes routine financial provisions as well as new policies that supporters say could save lives by bringing new drugs and medical devices to the marketplace more quickly.

The legislation would allow the continued collection of fees agreed to by brand-name drug and medical device manufacturers — in addition to launching new fees on generic drug makers — to fund FDA review and approval of product applications.

At the same time, the legislation would allow the FDA to create a “breakthrough” designation to speed the development of drugs that “may demonstrate substantial improvement over existing therapies” for those with serious or life-threatening illness.

The bill also would tighten oversight of the drug supply chain by requiring foreign manufacturers to register additional information about their facilities with the FDA, and it would enhance penalties for drug counterfeiting. More manufacturers would be required to give six months’ notice to the FDA if they discontinue certain drugs or have a supply shortage.

The fees are a key source of funding for the FDA, and failure to pass a bill before the existing authorization expires in September would result in layoffs. The bill would extend the fee agreements for five years, through fiscal 2017.

Proponents say the new fee on generic drug makers, estimated to bring in $300 million a year, would slash the time it takes to approve new drugs from 30 months to 10.

Senators rejected an effort by Sen. Richard J. Durbin, D-Ill., to regulate nutritional supplements and another by Sen. John McCain, R-Ariz., to loosen restrictions on Canadian drug imports.

Moments after passing the FDA bill, the Senate was squabbling again, blocking dueling measures that would prevent interest rates on new Stafford student loans from doubling to 6.8 percent on July 1.

Democrats and a handful of Republicans rejected the House-passed GOP proposal to gut a federal public health and prevention fund to pay for the $6 billion cost of the federal student loan subsidy.

Republicans followed suit by voting down the Democratic proposal that would close a tax loophole on wealthier households whose profits through their S corporations are not counted as income.

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