Meningitis Outbreak Drawing Attention to Quality Lapses at Major Drug Companies

Mike Rozembajgier
10-31-2012

Mold growing in rooms. Green and yellow residues. Standing water from a leaking boiler.

These were just some of the documented findings recently released in a U.S. Food and Drug Administration (FDA) preliminary report on conditions at the compounding pharmacy connected to the ongoing deadly meningitis outbreak.

Since the first fungal meningitis case tied to steroid injections was reported, compounding pharmacies have come under increased scrutiny by the media, lawmakers and other key stakeholders.

Critics argue that there is lack of federal oversight of an industry that is currently regulated only by state governments. They believe that state pharmacy boards are not adequately prepared to perform the kind of oversight necessary to prevent more drug-related outbreaks from occurring.

It’s a tough situation. Because the pharmacies taking the most heat are the ones that have played a critical role in ensuring that patients have the medications they need as extreme drug shortages continue to plague our nation. The challenge, critics argue, is that some compounding operations have grown to mimic full-scale drug manufacturers but still manage to escape FDA regulations.

Poor Recall Management to Blame for Drug Shortages?

Some people may point to the increasing number of pharmaceutical recalls as the reason for drug shortages. But poor recall management doesn’t paint the full picture of the problem. A recent New York Times piece discussing the fungal meningitis outbreak highlighted several quality lapses identified at major pharmaceutical companies that have led to drug shortages.

In fact, a recent Congressional report found that within just the past three years:

• Six of the major makers of sterile injectable drugs have received warnings by the FDA about serious violations of manufacturing rules;
• Four of those have closed factories or significantly slowed production to fix the identified problems; and
• A third of the industry’s manufacturing capacity is off line due to quality issues.

What Does This Mean For Pharmaceutical Manufacturers Moving Forward?

With the meningitis outbreak leading many to refocus on the safety of not just compounding pharmacies, but the drug manufacturing industry as a whole, those within the industry would be wise to ensure they are in compliance with all FDA regulations and guidelines.

In fact, to help those within the industry understand expectations, FDA has stepped up its efforts to work with drug manufacturers by hosting events to exchange ideas and recently implementing a program with its European counterpart, the European Medicines Agency (EMA).

Those who fail to adequately prepare for FDA inspections and comply with regulatory standards face media scrutiny, warning letters, product recalls and other forms of regulatory enforcement.

Do you think the state governments are to blame for safety issues stemming from compounding laboratories? Do you believe that compounding pharmacies should be regulated by FDA? We welcome your thoughts below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

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