Friday, November 23, 2012
FDA needs teeth to regulate drug compounders
Nov 23, 2012
The following editorial appeared in the St. Louis Post-Dispatch on Monday, November 19:
Congress is looking for someone to blame for the fungal meningitis outbreak linked to steroid injections that so far has killed 34 people and sickened nearly 500. In hearings last week, 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 nation's 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 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.
The big compounders function more like big pharmaceutical firms, but without the regulatory oversight that is so successful at ensuring the drugs you buy are untainted.
The second type of compounding pharmacies are more like neighborhood drug stores that mix medicines for individual parties. These clearly fall under state jurisdiction, while the FDA has clear authority to regulate drug companies.
It's the middle ground, which includes the big compounders, where the law is cloudy.
The problem has grown in the last two decades, just as compounding has grown. Their potions were used to help fill gaps during periods of drug shortages. Sometimes they were offered as less-expensive versions of commercial drugs.
With the accelerated market for compounded drugs, abuses occurred as compounders in the basically unregulated industry sought to make their potions even cheaper. One industry critic said specially mixed drugs don't have as much protection as do drugs manufactured for use on cats and dogs.
The recent deaths and illnesses are a call to action. People and business don't like regulations until they need them. There is no louder bell to ring than 32 deaths and hundreds of sick people.
Congress should give FDA the authority it needs to ensure that drug compounding is done with the same degree of professionalism and scrutiny that goes into drug manufacturing.
(c)2012 St. Louis Post-Dispatch
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