Tuesday, May 29, 2012

Go figure

The Senate miraculously found the bipartisan will to pass some important initiatives on prescription drugs Thursday, defying the conventional wisdom that election year rancor has made it impossible to get anything done.

The Food and Drug Administration Safety and Innovation Act could save both lives and money. Still it's remarkable that any bill, no matter how deserving, could win Senate approval by a vote of 96 to 1 at this time and in this Congress. That this one did is a triumph of months of transparent, bipartisan negotiation in committee, nudged forward by a bit of financial urgency.

"We have hit the sweet spot," said Democrat Sen. Tom Harkin of Iowa, the chairman of the Senate health committee who, together with Republican Sen. Michael Enzi of Wyoming, wrote the bill and shepherded it to passage.

Members of the House of Representatives should take heed, put what's good for the nation above their partisan interests and pass a similar bill slated for a vote in that chamber next week.

The Senate measure reauthorized user fees that FDA officials negotiated with brand-name drug manufacturers and medical-device companies that account for a sizable portion of the FDA's budget. And in an important first, it also authorized similar fees for the review of generic drugs. If signed into law, those new fees would pay for the agency to add enough staff to reduce the average time it takes for a generic to win approval from 30 months to 10 months. New staff would also help clear a backlog of applications. That would mean more competition and lower prices. The use of less expensive generic drugs saved American consumers almost $1 trillion from 2001 to 2010.

The current fee agreements will expire Oct. 1, so timely, bipartisan action in the House is essential. The new five-year deals would generate $4.1 billion in fees for the review of brand-name prescription drugs, $1.6 billion for generic drugs, and almost $1 billion for medical devices and "biosimilars" -- biological products, such as gene therapies, that are similar to those already approved.

The Senate bill would also help officials manage alarming shortages of some lifesaving drugs used in hospitals to treat cancer and systemic infections. It would mandate that companies making those drugs notify the FDA when production is disrupted. Currently notification is largely voluntary, and while there are signs of increasing cooperation, the system would benefit from some legal muscle.

The measure would also allow the FDA to target problem-prone overseas drugmakers for more frequent inspections, and authorize expedited reviews of breakthrough drugs for life-threatening diseases. And if the House agrees, the law could also require drugmakers to track each batch of a product from factory to pharmacy.

That's a full package of worthwhile initiatives. In all, the legislation should better equip the FDA to keep pace with the rapid progress in biomedical research, and also help contain health care spending by speeding lower-cost products to market.


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