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Remember Martin Shkreli, the pharmaceutical executive who jacked up the prices of an off-patent drug used by some AIDS patients last year and who was recently perp-walked for securities fraud? The Left treated his arrest as a victory for the common man, but it hasn’t made pyrimethamine, the active ingredient in Daraprim, any more available to those who need it.
Like.
See how that works, you just bust someone on unrelated charges because he stepped out of ideological lines, and he becomes the capitalist bad guy. Obama does it again!
Does the FDA do more harm than good? In this age of information and unlimited tort, is there not a much better way to deal with all of these issues.
Do we want to draw legal and regulatory attention to this “loophole” in the FDA? The far more likely outcome is that compounders suffer under the same crushing regulations as drug manufacturers.
Couple things on this. One is that the FDA’s role should be limited to assessing whether the new drug does no harm. Whether it’s effective should be beyond its purview and left to the market and to actual doctors in actual practice to determine whether it’s worth the price charged.
The other is that once the drug has been proven not harmful, both by legitimate initial testing and by its empirical performance while its patent is in effect, all a compounder or a genericist should have to show is a) he’s making what he claims to be making, and b) in the manner of a restaurant license, that he’s doing so in a clean and safe manner. Both of these are easily satisfied with an inspection of the premises. Further testing, FDA stalling, or incumbent manufacturer interference is unnecessary.
Eric Hines
The drug industry is caught in something of a pincers movement. On one side, federal policies from Hatch Waxman to the Affordable Care Act [sic] are designed to put downward pressure on drug prices; on the other, regulators never stop turning the quality ratchet on the drug supply chain. The result: drug shortages and “market failures” such as Turing Pharmaceuticals.
The issue with Daraprim pricing is that any new entrant must spend years and invest tens of millions of dollars to gear up to compete, in full view of the market, while Turing can afford to maintain market share by slashing prices the day after approval. Knowing this, no company will make the enormous investments to challenge the incumbent.
Compounding is a possible solution to this dilemma. I wish Mark Baum godspeed.
Good catch. In this day and age staying under the Fed’s radar is the only way to do business.