FDA Inspection Unearths Utter Chaos In Second Fungal Debacle

The Food and Drug Administration (FDA) has asked Congress to extend its oversight of large pharmacies that manufacture and distribute drugs, called compounding pharmacies. Currently, licensing for many of these facilities is the same as a mom-and-pop local pharmacy that sells one prescription at a time to customers. However, because these plants are actually making, storing and distributing drugs, their impact is more widespread and costly when a contamination issue exists.

Recently, authorities have linked a Tennessee pharmacy that makes and distributes steroids to an outbreak of fungal infections. During an inspection of the facilities, the FDA found spiders in a supposedly clean room, fungus and bacteria in vials of steroids, and no quality control procedures to monitor batches of the drugs being processed. There were 25 patients from four different states that that have developed infections after receiving injections of products from the Tennessee compounding pharmacy. The FDA says that the contamination may be similar to the 2012 case of the New England Compounding Center in which as many as 58 patients died after receiving steroid injections.

Not the First Time the FDA Has Tried

According to the Huffington Post, attempts by the FDA to increase its regulation of compounders date back to the 1990s. After strong pushback from the compounding industry, the FDA and the American public are left with the same vulnerabilities.

As reported by its trade group, the compounding pharmacy industry, which creates custom medicines by mixing drugs, does $3 billion of business in the U.S. and operates 7,500 pharmacies. In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.

Why Are There Compounding Pharmacies

The FDA regulates drugs produced for mass marketing, but not the compounders, who produce for a smaller market. Typically, regulation comes from state licensing boards. The compounders produce smaller quantities of drugs needed by a smaller segment of the population.

Drug shortages from conventional manufacturers also spur compounders into more manufacturing in an attempt to bridge the gap between demand and supply.

Are New Laws Needed?

Some lawyers say that new laws are not the answer. When the compounders crossed the line into manufacturing, they opened the doors to regulation under the same rules that the FDA is already applying to the mass-producers and marketers of drugs. Some quarters are questioning why the FDA is being hesitant to use the authority that it already has.

More information: 

Dangerous Drug Information and Recall Lawsuits

Personal Injury Attorneys in Phoenix, AZ

Additional information:
NBC News. FDA inspection finds a mess at pharmacy in second fungal outbreak. http://www.nbcnews.com/health/fda-inspection-finds-mess-pharmacy-second-fungal-outbreak-6C10302085?franchiseSlug=healthmain
Huffington Post. FDA Regulation Of Pharmacies Has Knotty History. http://www.huffingtonpost.com/2012/10/12/fda-regulation-pharmacies_n_1962234.html