FDA Actions Speak Louder than Words

March 21, 2014

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David Kile is Director of Continuing Education at Albany College of Pharmacy and Health Sciences.

The FDA is beginning to roll out a $20 million enhanced program to test the quality and safety of generic drugs. This initiative follows a string of high profile contamination cases, including one at a Massachusetts compounding facility in 2012 that led to an outbreak of fungal meningitis, eventually claiming the lives of 50 people.

This expanded commitment to ensuring the safety and quality of medications is being reflected at the highest levels of the agency. FDA Commissioner Margaret Hamburg recently visited with regulatory officials in India, where they signed a joint statement pledging to work together to prevent the distribution of unsafe drugs.

The Commissioner’s visit followed on the heels of a surprise FDA inspection of a factory complex owned by Indian pharmaceutical manufacturer Ranbaxy Laboratories. The inspection uncovered a number of alarming deficiencies – ranging from defective equipment to reports of windows stuck open to flies that were “too numerous to count.”

Ranbaxy has since been barred by the FDA from exporting products to the U.S., one of three Indian companies to recently receive such a ban. It’s a significant move – India produces approximately 40% of the generic and OTC products sold in the U.S. – that shows the agency is becoming more aggressive in its inspections and stricter with its penalties.

These bans, combined with the Commissioner’s visit, have put the world on notice that the FDA means business.

Early indications are that the message is being heard loud and clear. A financial analyst from Jefferies India Private Ltd reported that most Indian pharmaceutical companies have “increased their investment” in compliance as a result of these actions.

It should be noted that Indian companies sell about $5 billion worth of generics to the U.S., and the majority of these companies understand and comply with good manufacturing and quality processes.

The country finds itself in the spotlight now due to the recent FDA actions, but incidents related to drug quality and safety have also been documented in the U.S., China, Costa Rica, and numerous other countries, underscoring the global nature of the problem. So while the FDA is taking positive steps to address the issue, they clearly have their work cut out for them.

What is the ultimate impact of these moves on patients? Halting the export of generic drugs could result in shortages and resulting price spikes (generics account for 85% of all drugs taken in the U.S.). Additionally, for those physicians who have long been suspicious of the quality of generics, they may now be more likely to prescribe brand name drugs, which typically come with higher costs.

While none of these scenarios are desirable, most will view them as manageable obstacles if the ultimate outcome is safer, higher quality drugs.

David Kile is Director of Continuing Education at Albany College of Pharmacy and Health Sciences. He also teaches a course on Pharmacy Administration.