Lawmakers are pushing forward with legislation that could help create generic competition for Big Biotech, drastically lowering the costs of expensive biotech drugs and changing the landscape in the pharmaceutical industry forever.

The Senate is expected to vote Wednesday on a bill that would extend the 15-year-old process of requiring drug companies to pay fees to the Food and Drug Administration to help fund the drug review process. Advocates say the law has helped streamline the review process so that it takes months instead of years to get life-saving drugs approved for the market.

On the same day the Senate is voting, members of the House Energy and Commerce Committee are holding a hearing on a bill that would create a way for the FDA to review generic biotech drugs. Right now, there's nothing on generic biotech drugs in the Senate bill, and there's no guarantee that the bill will be modified.

Rep. Henry Waxman of California introduced a "biogenerics" bill in February along with Reps. Jo Ann Emerson of Missouri and Frank Pallone of New Jersey, as well Senators Hillary Clinton and Charles Schumer from New York.

The biogenerics bill would create a system for the FDA to review generic versions of biotech drugs, a $40 billion business in the United States last year, according to IMS Health, a drug industry research firm.

The bill has not yet been voted on in the House. Some believe that the best way to get the bill passed is for it to be folded into the FDA "reauthorization" bill, which has a much better chance of passing.

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Europe's drugmakers, under pressure from shareholders to improve sluggish returns, are taking a fresh look at debt on their traditionally unleveraged balance sheets.

AstraZeneca took the plunge decisively on Monday when it agreed to pay more than $15 billion in cash for U.S. biotech firm MedImmune in a move Chief Financial Officer Jon Symonds said would move it into permanent debt.

While the hefty price was criticised, many analysts saw the decision to embrace gearing as sign that times are changing in the pharmaceuticals industry, where cash piles have long been the norm.

"Astra are partly responding to what they are being told by the investment community, that you need to be progressively geared," David Beadle, pharmaceuticals analyst at UBS, said.
Bear Stearns analysts estimate AstraZeneca will have net debt of $7.7 billion by the end of 2007, against net cash of $6.5 billion at the end of 2006.

AstraZeneca is not alone.

More at Reuters

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While searching The Atlantic's bloggers Insider got to thinking about one of its old articles he had enjoyed reading.

Here's a taste:


Gene Carbona was almost a criminal. I know this because, thirty minutes into our first telephone conversation, he told me, “Carl, I was almost a criminal.”

I have heard ex–drug reps speak bluntly about their former jobs, but never quite so cheerfully and openly. These days Carbona works for The Medical Letter, a highly respected nonprofit publication (Carbona stresses that he is speaking only for himself), but he was telling me about his twelve years working for Merck and then Astra Merck, a firm initially set up to market the Sweden-based Astra’s drugs in the United States.

Carbona began training as a rep in 1988, when he was only eleven days out of college. He detailed two drugs for Astra Merck. One was a calcium-channel blocker he calls “a dog.” The other was the heartburn medication Prilosec, which at the time was available by prescription only.

It truly is one of the best reads Insider has ever enjoyed!

Read the full artcle here in The Atlantic