There were two interesting stories in yesterday’s FiercePharmaManufacturing, one showing what can happen when manufacturers feel the wrath of the FDA and the other, lamenting the still large roster of undersupplied drugs in the US. Are these connected?
The FDA has done a lot to help address potential drug shortages. In the first nine months of 2013, the agency apparently helped prevent 140 potential shortages, with only 38 actual shortages resulting over the period.
When a shortage of the ovarian cancer drug, Doxil (doxorubicin), was caused by manufacturing problems at an old Boehringer Ingelheim plant, the FDA allowed temporary import of a similar, unapproved drug and worked the manufacturer to help it obtain US approval. It is currently working with Johnson & Johnson to re-start manufacture at the now closed Boehringer plant, since the company has been unable to find a contract manufacturer to make Doxil.
Despite the FDA's efforts though, shortages are still a real problem in the US. The FDA now requires manufacturers to alert it to potential supply issues in time for the agency to make alternative arrangements. But this still leaves the problem of manufacturers who need to halt production to fix quality issues – apparently responsible for two thirds of US drug shortages.
Last year, Indian manufacturer Wockhardt had two of its manufacturing plants banned from exporting to the US. It recently reported a 30% fall in US exports – although they still account for over 40% of the company’s revenue. The more recent of the two FDA import alerts was only issued in November, so the firm faces even more depressed sales to come. In the last six months, the FDA has also banned two Ranbaxy Laboratories plants from shipping to the US.
India's Commerce and Industry Minister, Anand Sharma, believes the FDA did not give the Indian firms a fair hearing before imposing such harsh penalties. However, it’s important to note that the FDA has had its eye on Ranbaxy for years - since it was found to have faked analytical reports for its drug manufacturing. Last May, it pleaded guilty to a number of charges and agreed to pay $500 million in penalties to settle the ongoing case. In the case of Wockhardt, some of the issues were repeat violations from earlier inspections. Wockhardt has also had plants banned by the UK.
I’m not for a moment suggesting that anyone lower standards – tight quality controls are essential to the supply of safe and effective pharmaceuticals. But how can these two conflicting pressures be resolved to the benefit of the patients?
Where should the FDA draw the line separating expediency and good manufacturing practice?
Maybe it has the balance entirely right and its actions will pressure the industry to adopt higher standards overall?
Only time will tell. Time during which drug shortages in the US will probably continue to grow.
Whitehall Training publishes a course on Good Manufacturing Practice as it applies to experimental drugs. GMP (annex 13) is delivered online and available in six key languages.
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