: FDA needs teeth to regulate drug compounders : Stltoday

Editorial: FDA needs teeth to regulate drug compounders : Stltoday

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People have died. Others still are sick and suffering the consequences of the tainted drug.
Congress should stop pointing fingers and write the sort of laws that will make it clear the FDA has authority over every step of the making of compounded drugs. Such drugs are for small-batch specialty medications not readily available.
Dr. Hamburg testified that the law doesn’t even include a clear definition of what compounding is, and that conflicting court decisions on the matter have further mucked up the findings on regulatory responsibility.

There are two distinctly different types of drug compounding. One is the type that was done by the New England Compounding Center of Framingham, Mass., which is where the tainted injectable steroid used to treat back and joint pain was made. The company has shut down, surrendered its license and recalled all its products since the problem was discovered.

For 20 years such large compounding companies have been at the center of dire warnings about the potential for health hazards, and have been threatened with federal intervention. The compounders dodged tough federal oversight by positioning themselves as lower-cost, community-based alternatives to “big pharma.”

Even though the current attack on the FDA is partisan, the effort to help compounders dodge oversight was bipartisan. Both the late Sen. Edward M. Kennedy, D-Mass., and former House Majority Leader Tom DeLay, R-Texas, aided the industry.