Regulations Born of Bad Behavior

In an ongoing series on the drug compounding industry, appears this appalling finding:

when the F.D.A. began seeking samples to test, the trade group representing compounding pharmacists went on the offensive. Instead of encouraging members to help the agency determine if the injectable drug, used to reduce the risk of premature birth, was substandard, the group tutored pharmacists on how to sidestep requests.

In an e-mail to members, the International Academy of Compounding Pharmacists suggested that they respond to any request for samples by saying, “We do not compound or distribute ‘samples’ of any of our prescription medications to anyone.” And if a compounded drug was on the premises, the trade group added, a pharmacist should say it was awaiting pickup by a patient.

In Texas, a hub of compounding pharmacies, random tests by the state’s pharmacy board over the last several years found that as many as one in four compounded drugs was either too weak or too strong. The testing results are just slightly better in Missouri. Potency varied by as much as 300 percent in the Missouri tests.

And records of F.D.A. drug seizures at United States borders, as well as several criminal cases, point to a link between drug compounders and Chinese manufacturers, some not registered with the F.D.A.

NO need to wonder what the Romney-Ryan position on this:  it can’t happen.  Free markets are self regulating…  To give the FDA more teeth would be to impede trade and business….

Leave a Reply

Your email address will not be published. Required fields are marked *