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US generics group's drug shortage plea

The US Generic Pharmaceutical Association (GPhA) has blamed intensified regulation for drug shortages in the US and called for greater collaboration between stakeholders to solve the crisis

The record number of drug shortages currently ongoing in the US is a result of intensified regulatory inspections, said Paul Bisaro, chairman of the industry trade body Generic Pharmaceutical Association (GPhA) and CEO of Watson Pharmaceuticals.

Speaking to the Financial Times, Bisaro said higher costs incurred by generic manufacturers due to heightened inspection efforts from the US Food and Drug Administration (FDA) had led several companies to stop producing less profitable medicines.

He said: "Government has to be sensible. We have drug shortages caused by inspection issues. Where it is going to impose restrictions, it needs to be thought through."

Speaking at an FDA workshop discussing the shortage problem, new president and CEO of the GPhA, Ralph G Neas, said greater collaboration between stakeholders was key to any solution.

In his first public presentation in his new role, Neas proposed that any solution to a shortage of medicine required all components of the supply and provider network to co-operate to address the problem.

This included brand manufacturers, active ingredient suppliers, component suppliers, wholesalers and distributors, group purchasing organisations, healthcare providers and the FDA in the US.

Drug shortages can be the result of many factors, including manufacturing and quality problems, delays, poor communication and discontinuations.

There are over 200 shortages in the US currently listed by the American Society of Health System Pharmacists.

The FDA said: "When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients.

"FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients."

3rd October 2011

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