Doxycycline Shortage and FDA Ban on Indian Drug Importer

by lmatthews on June 5, 2013

fda wockhardt ban doxycycline price increaseWe recently reported on a shortage of the Lyme disease antibiotic, doxycycline, and the resulting spike in the cost of the drug. Following an import ban imposed by the FDA on an Indian manufacturing plant, Wockhardt, the situation looks set to worsen. The increased price of doxycycline and the lack of availability in some areas is not a sign of pharmaceutical giants conspiring to increase prices as some are claiming, instead, this is the unfortunate and hopefully temporary effect of a government agency actually doing its job and safeguarding consumer health to the best of their ability.

Loss of Profits for Wockhardt

According to Reuters, the US Food and Drug Administration imposed an import alert on a plant operated by India’s Wockhardt Ltd., an action which resulted in a 20% fall in the company’s share-price and a sudden cut in the amount of a common Lyme disease drug available to physicians and veterinarians in the US. Doxycycline is a key drug to battle the Lyme disease bacteria, Borrelia burgdorferi, and is used to treat humans, companion animals and farm animals. Other antibiotics are available but doxycycline is usually favoured for its effectiveness for a wider range of patients.

Import Alert for Patient Protection

An import alert is effectively a ban on importing products, in this case drugs, and means that any goods that are shipped are seized and held indefinitely. The Indian plant has not met the Good Manufacturing Practices that the FDA demands from companies in order to sell their drugs in the US, meaning that the drugs may prove to be of substandard quality, contaminated, improperly labelled, be of a different dosage from that stated or have some other defects that can imperil patients’ health.

Doxycycline Shortage not a Conspiracy by BigPharma

This is not a case of an artificially created squeeze on doxycycline in order to allow drug companies to vastly increase their prices. Instead, the FDA’s action is likely to result in some $100 million in lost revenue for Wockhardt this year, unless they work rapidly to shift manufacture to another facility that meets the manufacturing standards necessary for import. This may be achievable within the next 6-9 months, which is great news for those worrying about Lyme disease treatment in the future but not so great for those who have just learnt that they are infected with the bacteria. Alternative Lyme disease antibiotics include Zithromax, cefuroxime axetil, and erythromycin although these have different safety profiles and levels of effectiveness against Lyme disease and coinfections.

Read more about antibiotic treatment for Lyme disease here.

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