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January 10, 2008

Drug Approvals in 2007

by @ 11:27 am.  Filed under FDA

Here are a couple of good blog postings about the low number of drug approvals in 2007.

The IN VIVO Blog: Another Dismal Year for New Drug Approvals:

Where have all the new drug’s gone: Industry’s medicine cabinet running empty on compounds- NJ.com

With only 18 approvals it is the lowest since 1983 when there were only 14. The FDA says final figures won’t come out until March but even then most of us think the total will likely not be any higher than 19. While there seem to be a lot of theories as to why this is the case, I don’t think there is any one singular explanation. I personally think it is a combination of the FDA being more cautious (although the FDA denies this and says there has been no policy change) and the fact that all the low lying fruit has been picked and it is indeed much harder now to find new and innovative therapies.

I do believe that some of the recent breakthroughs in basic research such as the human genome will eventually lead to new drug discoveries but that one of the primary issues is everyone under estimates how long it takes to go from basic research to commercial application, especially in the drug industry. This is one of the primary mind traps that everyone falls into in all industries but it seems to be exaggerated in the pharmaceutical industry.

I’m not sure what will help the situation and I’m not confident it will turn around soon. I am confident that in the long run, the issue will be resolved. I just hope it doesn’t take too long.

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    January 2, 2008

    PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin

    by @ 10:08 pm.  Filed under FDA, Pharma News

    Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.

    PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

    Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

    I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

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    The FDA and 2008

    by @ 9:55 pm.  Filed under FDA

    It will be interesting to see how things develop with regards to new drug approvals and the FDA in 2008.
    My guess is that for new drugs for which treatment already exists that the FDA will continue to demand evidence of not only of safety and effectiveness but also that is is an improvement over the currently available treatments. This seems to be shared by Fierce Biotech.

    The FDA: Caught between a rock and a hard place - FierceBiotech

    I can understand the FDA reacting to recent situations such as Vioxx but they do indeed seem to be sending a mixed message; emphasizing the need for speeding drugs to market but then seeming to have set a higher standard. THe FDA says therre jave been no policy changes but the fact that only 15 new drugs were approved in 2007 seems to indicate otherwise.

    I just hope that we can have a open and honest discussion about risk management and acknowledge that all drugs have risk and many times that full impact of that will not be determined until after the drug has gone on the market.

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    October 4, 2007

    Review of Important Items from Sept 17-30

    by @ 8:00 am.  Filed under FDA, Pharma News, Pharma

    Here are a few of the important articles from the last couple of weeks.

    Glaxo set to axe staff as crisis hits drug - Telegraph
    Generic Biotech Drugs Won’t Be in U.S. Legislation Bloomberg.com: News
    The Scientist : New patent rules hurt biotech?
    Chemical & Engineering News: Government & Policy - Patent Reform Inches Ahead
    AstraZeneca to outsource manufacturing - Times Online
    AstraZeneca To Outsource Drug Manufacturing - Contract Pharma
    StockHouse.com : Encysive Pharmaceuticals Receives Written Response From FDA On
    Cephalon warns over pain drug deaths| Reuters
    PharmaLive: Adverse Drug Events Reported to FDA Appear to Have Increased Markedly
    Sanofi-Aventis Developing New Drugs: Financial News - Yahoo!
    Finance

    House Passes Bill to Improve Drug Safety: Financial News - Yahoo!
    Finance

    Senate OKs FDA drug safety bill - washingtonpost.com
    Many drugs slip through regulatory ‘black hole’ - CNN.com
    Bristol-Myers to buy partner Adnexus for $430 million”>SignOnSanDiego.com >
    Warning issued on Cephalon painkiller | Philadelphia Inquirer | 09/27/2007

    My overall observations is that there are many factors influencing the pharma industry today and these are not likely to less anytime in the near future. It would be nice to see more positive articles but those seem to be hard to come by in the current environment.

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    September 7, 2007

    No Generic biologics in FDA legislation

    by @ 2:36 pm.  Filed under FDA, Pharma News, Pharma

    Reuters is reporting that the new FDA legislation is unlikely to have any biogenerics in it.

    UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters

    I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress on how and when they will implement some kind of program.

    Here is the key from my perspective.

    The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

    I realize that biologics are not like standard drugs in terms of generics but really think that until Congress demands that the FDA come up with some sort of plan, nothing will move forward. It is too bad that Europe will be the one taking the forefront in this movement. As an example, EMEA just approved a follow-on for EPO for Sandoz, Novartis’ generics division.

    Sandoz Receives European Commission Approval for biosimilar epoetin alfa

    I know there will be a lot of lobbying of Congress on this issue but think that regardless there needs to be some sort of plan put forward. Just trying to delay and avoid the issue is only going to cause more public relations problems for biotech in the future.

    Other Recent Stories Related to Biogenerics

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    Biopharmaceuticals | Follow-on Biologics: Friend or Foe? | Pharmaceutical Manufacturing
    Patent Baristas » Senate Committee Approves Follow-On Biologics Bill: Fear and Trepidation Follow
    Biologics Price Competition and Innovation Act of 2007 (S. 1695)

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    June 16, 2007

    Dr. Reddy’s To Market Generic Ambien

    by @ 10:15 am.  Filed under Health News, FDA, Pharma News

    Since I use Ambien on occasion it was good to hear Dr. Reddy’s Lab is no approved to sell generic Ambien.

    Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

    I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

    While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

    Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

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    May 21, 2007

    Dr. Reddy’s To Market Generic Ambien

    by @ 7:54 pm.  Filed under Health News, FDA, Pharma News

    Since I use Ambien on occasion it was good to hear Dr. Reddy’s Lab is no approved to sell generic Ambien.

    Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

    I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

    While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

    Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

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    April 28, 2007

    FDA Rejects Merck’s Arcoxia

    by @ 10:24 am.  Filed under FDA, Pharma News, Pharma

    It isn’t surprising that the FDA rejected Merck’s NDA for Arcoxia, its follow on to Vioxx since an advisory committee already voted 20-1 against its approval. Forbes has an article on it.

    FDA Rejects Merck’s Vioxx Successor - Forbes.com:

    It is interesting to note though that Arrcoxia is on sale in 63 countries world-wide already. It be be interesting to see what effect if any it has on world-wide sales.

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    March 26, 2007

    Drug Safety from Pharmaceutical Manufacturing

    by @ 6:03 pm.  Filed under FDA, Pharma News

    In get caught up on some reading, I came across this article from Pharmaceutical Manufacturing concerning drug safety.

    Drug Safety | The Harmful Side Effect We Never Hear About / Congressional Cures? | Pharmaceutical Manufacturing:

    I reported recently about drug safety and establishing database and this article has even more details. I highly recommend these two articles article. They were written by Dr. Henry I. Miller of the Hoover Institution. He is an ex-FDA who worked at the administration from 1979 until 1993 and was one of the founding directors of the Office of Biotechnology at the FDA where he served as head from 1989-1993. The first is about harmful side effects of drugs and the mismanagement at the FDA and the second deals legislation currently before Congress. I highly recommend both of these articles.

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    March 9, 2007

    Would Imported Drugs Create Savings?

    by @ 12:13 pm.  Filed under FDA, Pharma News

    The Washington Post had an article earlier this week where experts questioned whether or not allowing imported drugs would result in significant saving for US customers.

    Expert Questions Import Drug Savings - washingtonpost.com

    Stephen Schondelmeyer, a University of Minnesota pharmaceutical economist testified that imports would cut U.S. prices by only 12 percent to 20 percent (emphasis mine). I’m not sure what this economist think is significant but for many people on fixed incomes who are paying hundreds or dollars (or more) each month for prescription drugs this is indeed significant! I think it may again be a case of someone in an ivory tower not being in touch with some of the concerns of normal everyday people.

    As regular readers know though, this doesn’t mean I favor drug imports. I also don’t think the safety issue usually raised is insurmountable, but it would be costly and I doubt congress would increase the FDA budget enough to allow it to do this job thoroughly and safely. My disfavor of this approach is simply based on populations of the listed countries. Usually this list includes Canada, New Zealand, Australia and some European countries (but never specifically identified).

    Excluding Europe for now (I’ll comment on that below) these other countries are so small in population that the US, if even a small percentage of people imported drugs, it would easily strip them of their supplies. Also, some drug companies have already stated that if this occurs, they will only sell certain amounts of drugs to these countries and they would have to decide whether to sell them to their own people or export them to the US but that the drug companies would not allow the purchase of huge amounts of drugs just so those countries could export them to the US.

    It should also be noted that in Europe, drug companies must negotiate prices directly with the government since in most cases they are the sole healthcare provider (this could be looked at as another reason why the US should seriously consider universal healthcare, but that’s another subject for another time). If you ask people on the street here in the US if they favor price controls on drugs, most will say no. However, this is basically what would occur. Importing drugs from Europe would essentially be saying we agree with the price controls of foreign governments. If we truly believe that, then why not just pass legislation with price controls tied to those in Europe?

    My larger concern is that Congress has a history of giving the FDA additional responsibility but has not given them an increase in funding to achieve those responsibilities. They are already underfunded by most experts estimates and setting up a new system to deal with drug imports would be costly at least at first. Then there are other issues Congress wants the FDA to deal with such as biogenerics and a drug safety database. This is one of the reasons I favor giving the FDA powers similar to the EPA of fining drug companies for infractions of the rules.

    The bill being discussed is S424 (S. 242–110th Congress (2007): Pharmaceutical Market Access and Drug Safety Act of 2007

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