FDA Stings Pharma, Big and Small

The first shock came after Merck (MRK) and Schering-Plough’s (SGP) Vytorin ENHANCE study. Surrogate markers like cholesterol counts would no longer be enough to garner marketing approval. Genzyme (GENZ) and Isis (ISIS) received the first blow. Isis’ cholesterol drug Mipomersen would have to undergo an outcomes study before widespread usage is approved. This has caused a bit of “rethinking” in the Genzyme-Isis partnership.

The Wall Street Journal “Merck Sees Wait on Cordaptive” reports that not only is the FDA unhappy with Merck’s chosen name for its new cholesterol drug, but it also wants to wait for the results of a long-term study to be completed in 2013. The FDA most recently told GlaxoSmithKline (GSK) that its Ligand (LGND) partnered PROMACTA drug for increasing platelet counts and reducing or preventing bleeding would be delayed three months, even though the drug was on fast track. GSK was seeking approval for short-term use, but the FDA was concerned that once approved, long-term use could not be prevented.

The FDA is starting to show concern for abuses in marketing long-term or “lifestyle” use of drugs for perceived chronic conditions that have no real efficacy, or even cause harm. The FDA is also showing reluctance to approve drugs based on minor convenience enhancements, such as less frequent dosage.

The New York Times “Release of Generic Lipitor Is Delayed” reports the growing concern by the FTC on sweetheart deals between big pharma and generic drug companies to delay generics. Pfizer (PFE) and Ranbaxy Laboratories agreed to delay generic Lipitor for almost two years for what might be construed as a payoff. Pfizer threw slow-selling Caduet into the mix.

What we are seeing is some “free market” bending to combat European-type tight cost-benefit controls. The government is slowly putting an end to the lucrative cholesterol and other continuous use drug franchises by delaying new patented drugs while generics gain ground. I believe this is a conscious plan.

The biological drug picture is mixed. The June Nature Biotechnology reported that the FDA rejected Genzyme’s application to move Myozyme from a 160-liter production to a 2000-liter production, even though the treatment for Pompe disease is in short supply. The FDA contends that different scale production could lead to differing carbohydrate structures. Nature concludes that if Genzyme cannot be trusted, generic biologicals do not stand a chance.

All is not lost in controlling the cost of biologicals. I think they are close to hitting the wall on pricing. Cancer treatment is migrating toward cocktails similar to the treatment for AIDS. No insurer can afford to pay for a mixture of $50,000 a year drugs.

Disclosure: Author is long ISIS, LGND and PFE.

Comments

[gaucho]

Article by Evelyn Pringle ON FDA CORRUPTION & SELLING OF INSIDER INFORMATION

www.opednews.com/artic...


Bush's FDA - Perpetual Leaker of Insider Information



by Evelyn Pringle Page 1 of 7 page(s)

Bush's FDA - Perpetual Leaker of Insider Information

The steady leaking of insider information about products under review by the FDA has caused enormous losses for average American investors since the Bush Administration took control of the agency six years ago.


There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.

But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.

When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss. >>>>>&g...

[User 26737]

But the king george iii bush administration has been so honest with his peasants ......... most corrupt and worst EVER

[langman]

the FDA has been awful for a very long time.

Dub Ya is not the one to blame here so get past it.

leaks from the lab > get past it.

these stocks are lousy because of their growth potential and the fear of further profit restrictions.

[Tom B]

The FDA is broken. If you ask the "man on the street", he might say the FDA approves "dangerous" drugs because they are not 100% safe in humans at "elephant" dosages. But, the truth is, the FDA's snail pace is costing the drug industry billions and adversely impacting consumer health. A perfectly safe used-in-the-EU testosterone product from Invedus was put on lengthy delay because a patient coughed a few times in clinical trials. "Plan B" OTC was delayed for years because the "Bushies" have a purely political distaste for women's health products.

The FDA is run right now with all the competence of FEMA during Katrina-- it's all do-nothing cronies.