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Kathianne
03-03-2013, 07:22 PM
http://blogs.the-american-interest.com/wrm/2013/03/01/fda-crushing-pharmaceutical-growth/


March 1, 2013 FDA Crushing Pharmaceutical Growth Government regulation is stifling America’s vibrant pharmaceutical industry. A recent report by the President’s Council of Advisors on Science and Technology estimates that it costs an average of $1.2 billion to win FDA approval and bring a new drug to market. Given that biopharmaceuticals account for roughly two percent of the economy, this is no small matter.


The chief problem is the complex process of clinical trials, in particular “Phase 3,” in which a drug is tested and retested to prove its its effectiveness in treating conditions across a broad population. These trials have a strong track record, but they are poorly suited to new biopharmaceuticals, which are often very effective in smaller, targeted groups despite a lower success rate in the public at large. Under the current system, many of these drugs may fail their trials despite their effectiveness when prescribed correctly.


Two industry insiders have proposed a solution in a Bloomberg op-ed (http://www.bloomberg.com/news/2013-02-28/fda-reform-can-lift-u-s-economy.html): Replace Phase 3 with a market system, allowing patients and doctors to determine which drugs are effective by monitoring the real-world results:

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Robert A Whit
03-03-2013, 07:49 PM
Credit to Kathianne for the following.

March 1, 2013 FDA Crushing Pharmaceutical Growth

Government regulation is stifling America’s vibrant pharmaceutical industry. A recent report by the President’s Council of Advisors on Science and Technology estimates that it costs an average of $1.2 billion to win FDA approval and bring a new drug to market. Given that biopharmaceuticals account for roughly two percent of the economy, this is no small matter.


The chief problem is the complex process of clinical trials, in particular “Phase 3,” in which a drug is tested and retested to prove its its effectiveness in treating conditions across a broad population. These trials have a strong track record, but they are poorly suited to new biopharmaceuticals, which are often very effective in smaller, targeted groups despite a lower success rate in the public at large. Under the current system, many of these drugs may fail their trials despite their effectiveness when prescribed correctly.


Two industry insiders have proposed a solution in a Bloomberg op-ed (http://www.bloomberg.com/news/2013-02-28/fda-reform-can-lift-u-s-economy.html): Replace Phase 3 with a market system, allowing patients and doctors to determine which drugs are effective by monitoring the real-world results:

I am one of those who take the daily multi-pack vitamins (Waiting on Obama to pick up that tab), Fish oil capsules and a variety of drugs (all Generic) paid for by taxpayers.

The cost to win FDA approval ought to mean drugs are always safe but recently on the TV news a drug approved by the FDA had to be pulled from the market due to unsafe issues.

$1.2 billion dollars is far too much. This cost has to be put into the charges of those taking said drugs. At long last, some good drugs are lower priced.
It is hard for me to get a handle on the cost of my drugs since by not paying for any, I am immune from taking note of prices.

I happen to like the idea of Kathiannes article. Engage the pharmiscists more too. They seem to know a lot more about drugs than doctors know.

Democrats pretend Bush messed up by not using the VA system. But truth be told, many many insurance companies fight for our business and they hassle the drug factories.

With the VA, they can have cost over-runs. They can have lazy or ineffective folks at the VA doing the bidding. But when drug companies have many many insurance companies all fighting for the same business, we the taxpayer public get a much better deal.

Many bees making honey produces good results. The insurance companies play that role.

fj1200
03-04-2013, 07:58 AM
http://blogs.the-american-interest.com/wrm/2013/03/01/fda-crushing-pharmaceutical-growth/

Decades of resting on our successes is coming home to roost.