FDA’s Announcement of Negative Audit Findings Lead to Similar Actions by Other Regulators

When FDA audits a company and find smajor deficiencies followed by publicly disclosing its findings, other regulatory agencies in the rest of the world also take notice. Hospira learnt it the hard way recently when Health Canada banned products manufactured at Hospira’s facility in Italy specifically citing the “reliability of the laboratory data” and FDA’s warning letter for its decision to ban the drugs. Although the Canadian agency’s decision doesn’t impact all the products produced by Hospira, it’s surely going to point at the irregularities prevailing at many of its plants. It’s also going to impact the proposed buyout deal by Pfizer, which is worth $16 billion. Hospira has been receiving FDA warnings letters since 2013 and enforcement action is likely to happen at two of its facilities, one in the U.S. and another in Australia. The issues aggravated to such a high degree in July 2014 that FDA had to ask the company to immediately undertake a comprehensive assessment of all its global manufacturing units and to make sure that they were compliant with FDA requirements. It was followed by several product recalls by the drug manufacturer. This is not the first time that FDA’s negative audit findings led to regulatory actions by other regulators. Similar fate awaited several generic drug manufacturers in India and China where severe FDA action led to similar actions by regulators in Europe, Australia and Canada. One more example of why one should pay attention to FDA’s audits, not just for doing business in the US but to assure compliance with global markets.