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FDA and EMA set out efforts to mitigate GMP-related shortages

By Gareth Macdonald , 14-Aug-2012
Last updated on 14-Aug-2012 at 12:11 GMT

FDA and EMA set out efforts to mitigate GMP-related shortages

Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week.

First up is the US Food and Drug Administration (FDA), which outlined its efforts to prevent shortages of bladder cancer drugs after Sanofi Pasteur halted production of TheraCys BCG Live (Intravesical) in response to an agency warning letter .

In the announcement the agency said it has asked Organon Teknika, a unit of US drugmaker Merck & Co, to increase production of its product TICE BCG Live (Intravesical), which is the other treatment licensed in the country.

It also asked other manufacturers of similar products to contact it if they are willing to help and requested that physicians do not stockpile the drug, warning that this type of hoarding is only likely to make potential shortages worse.

Sanofi, which halted production at its plant in Toronto, Canada in June does not expect manufacture of its drug to resume until last next year.

The FDA's publication of its efforts follows just a few weeks after it hit back at a report by the House oversight committee, which argued the agency was largely to blame for recent high-profile drug shortages .

In a response letter sent in July Jeanne Ireland, assistant FDA commissioner for legislation, disputed these claims and stressed that the agency “responds to potential drug shortages by talking actions to address their underlying causes and enhance product availability.”

EMA sets out incident management plan

Meanwhile in Europe the European Medicines Agency (EMA) has also discussed how it addresses drug shortages in an explanation of the EU incident plan for human medicines , which was published yesterday.

While the majority of the document focuses on issues related to pharmacovigilance, its section on public health incidents covers supply shortages caused by manufacturing or GMP compliance problems, which the EMA says should be dealt with using the plan.

The EMA’s approach is to establish an Incident Review Network (IRN) – composed of agency staff and representatives from the European Commission (EC) and national authorities - to assess reports and – in the event of a good manufacturing practices (GMP) -related supply shortage – advise on how best to rectify the situation.

Like the FDA's decision to detail its shortage mitigation strategy, the new EMA explanation document fits with efforts the agency has made to address such concerns this year, notably the workplan it adopted in January .

In that document the European regulator said: “In the light of recent GMP and manufacturing problems leading to supply shortages, the Management Board agreed that ensuring the security of the manufacturing supply chain of medicines is an important aspect of maintaining the availability of medicines.

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