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DewDiligence

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DewDiligence

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Re: bladerunner1717 post# 37088

Thursday, 11/09/2006 1:14:20 AM

Thursday, November 09, 2006 1:14:20 AM

Post# of 253650
Help could be on the way re funding for
generic-drug applications. Reconsideration
of the wisdom of permitting “authorized
generics” could be in the offing. Progress
could be expedited on the biogeneric
quagmire.

http://online.wsj.com/article/SB116304017868618146.html

>>
Big Pharma Catches a Chill

By AVERY JOHNSON and ANNA WILDE MATHEWS
November 9, 2006

Fears that Democrats will tackle drug pricing have investors reconsidering the pricing of drug stocks, too. Shares of major pharmaceutical companies slipped yesterday amid concerns that Democrats will push for changes that could cut prices paid under Medicare for some medications, among other things.

Still, analysts cautioned that Democratic control of the House of Representatives is unlikely to bring much immediate change for the industry. For one thing, many proposals on the Democrats' agenda could face a veto from a Bush White House, if they make it that far.

Even as the Dow Jones Industrial Average hit a record, the Dow Jones Wilshire U.S. Pharmaceuticals Index fell 1.7%, a reversal from the upward trend that has lifted the group about 17% in the past 12 months. Merck shares fell 3.4%, Schering-Plough lost 2.5% and Pfizer dropped 1.6%.

...Democratic leader Nancy Pelosi of California, who is expected to become speaker of the House, has said Democrats will introduce legislation allowing the government to negotiate directly with drug companies to secure better prices for medications offered to senior citizens under Medicare. Democrats also have backed making generic drugs more accessible and expanding the ability to import cheaper drugs from overseas.

Democrats' new dominance in the House -- and possibly the Senate -- could bolster drug-safety efforts at the Food and Drug Administration. Democrats have a chance to put their stamp on critical legislation that must be renewed next year, including FDA user fees and the law that gives drug companies extended protection against generic competition if they study the use of their medications in children. Democrats will be able to launch and lead investigations and oversight hearings that will likely focus on drug pricing and safety.

Rep. Henry Waxman of California, who will now be chairman of the House Government Reform Committee, has introduced a bill to create a pathway for generic versions of biotech drugs. Though the complexity of the issue makes quick legislative changes unlikely, it will likely find more traction with Democrats in charge.

Democrats are also eyeing other moves, including boosting funding for the FDA's generics-drug office. They may also look to discourage some tactics that the branded drug makers use to protect their turf, such as deals for so-called "authorized generics."

"There's no question that the world just changed for us, but it's not a big surprise, and no one's panicking," said Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, the industry trade group. He vowed to redouble public-relations efforts leading up to the 2008 presidential election, which he called "even more important" than most elections for the drug industry.

…Some on Wall Street are concerned about whether the election results foretell a Republican loss in 2008. "If this is an indictment of the Republicans, then it does not give the industry a warm-and-fuzzy feeling for the presidential election in 2008," said Barbara Ryan, a pharmaceutical analyst at Deutsche Bank.

In the near-term, Democrats are likely to support new powers for the FDA. A senior Democratic House staffer with experience in health care says Democratic lawmakers are likely to be "very receptive to the recommendations" in a recent report from the Institute of Medicine, an independent research organization that advises the federal government. Changes called for in the report include restrictions on direct-to-consumer advertising for the first two years a drug is on the market.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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