Newspaper article St Louis Post-Dispatch (MO)

Compounding Tragedy; Our View; FDA Needs Teeth to Regulate Compound Drug Industry; OPINION

Newspaper article St Louis Post-Dispatch (MO)

Compounding Tragedy; Our View; FDA Needs Teeth to Regulate Compound Drug Industry; OPINION

Article excerpt

Congress is looking for someone to blame for the fungal meningitis outbreak linked to steroid injections that so far has killed 32 people and sickened 461. In hearings last Wednesday, partisan politics took the place of fact-finding.

Republicans on the House Energy and Commerce Committee accused Margaret Hamburg, commissioner of the Food and Drug Administration, of not acting fast enough to shut down the Massachusetts pharmacy that is linked to the outbreak.

Democrats on the subcommittee conducting the hearings defended Dr. Hamburg. They said it was the responsibility of Congress to clear up any ambiguity that may exist in policing compounding pharmacies.

For her part, Dr. Hamburg asserted that oversight of the nations specialty drugmakers falls through cracks in the regulatory system. No single agency has clear authority, she said, calling on Congress to give the FDA more and better-defined regulatory power.

We need strong, clear appropriate legislation, Dr. Hamburg said. We cannot have a crazy quilt where different parts of the country have different rules.

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 doesnt 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. …

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