November 2, 2012

Will Congress Revisit Compounding Pharmacies Issue?

How many more deaths is it going to take to convince our congressional leaders to do what should have been done about a decade ago. Compounding pharmacies have lobbied so long and hard on Capitol Hill that they have been able to remain unregulated. This is a little-known fact about the pharmaceutical industry and how they have been able to operate without supervision for so many years and out of sight of the public. The pharmaceutical industry through their compounders has been able to lobby against regulation oversight and impress the politicians and their staffers for the need of compounding.

If congress does not act, some groups may be able to if they follow actions by Sandra Fusco, director of patient advocacy at Allergy & Asthma Network Mothers of Asthmatics. She took on the Compounding Industry and succeeded in forcing them out of the nebulizer drug business. When the nebulizers were found out to have contamination and poor potency, she and her supporters succeeded in getting insurers not to reimburse for compounded nebulizer drugs. This may be one way to force compounders to correct their errors. Don't take this to the bank as the compounders are well established on Capital Hill and know how to bring in people to plead their case for drugs not otherwise available in regular channels.

Even some of our well-known hospitals are not ordering medications from certified pharmacies. John Hopkins University had scientists investigate bacterial infections in six intensive care unit patients. They traced the infection to contaminated fentanyl from a compounding pharmacy. The trouble is they assumed any drug bought in large quantities by a healthcare facility comes from an FDA-approved and licensed manufacturer. When this information was shared with the hospital pharmacists, they said they could not stop ordering from compounders: they were the only source of the fentanyl doses the ICU needed.

Even with deaths from medications received from compounding pharmacies, only 162 of several thousand compounding pharmacies have become accredited. In order to obtain accreditation, an on-site inspection is made to assess workers' competence, equipment, record keeping, air quality and clean-room qualities meet certain standards. Even this has not made the market demanding accreditation. Who pays the price for this lack of oversight – the patients of course!

Now, as the deaths and illnesses mount from fungal meningitis linked to a contaminated steroid injection, the question of why early concerns about pharmacy compounding did not change U.S. law is a top focus for patients, regulators and lawmakers.”

The FDA has traced the steroid injections to New England Compounding Center, or NECC, a Framingham, Massachusetts compounding pharmacy founded in 1998. Unfortunately, this is just the tip of the problem with much wider implications. It is highly doubtful that this will bring about actions necessary to bring these compounding pharmacies under FDA control or even oversight. We don't know how much is being funneled into campaigns to insure no legislation will result.

You can be sure that once the elections are over, lobbying will begin in earnest and these compounding pharmacies will go to their people that rely on their compounds to lobby on their behalf. This problem with the compounding pharmacies is one that I hope Congress will finally do something to bring them under supervision and closer regulation. I nothing more stiff penalties need to be imposed and I am not suggesting a few thousands, but a minimum of half a million since these compounding pharmacies a killing people because keeping equipment sterile seems to take second place to profits.

Other information can be read here about a congressional representative calling on the Department of Justice to conduct an investigation into whether NECC violated federal laws designed to stem illegal activity in controlled drugs. Then this article discusses some of the other compounds involved in the meningitis outbreak by NECC.

And now there is new information about the sister compounding pharmacy in Westborough, Massachusetts.  This compounding pharmacy, Ameridose, has issued a recall of all its products in cooperation with the FDA investigation because of sterility issues. 

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