Decoding the need for a new FDA office on quality

The US Food and Drug Administration (FDA) is turning the heat on maintenance of quality standards, and Indian pharmaceutical companies, already complaining of a strict, forensic-style inspection by the drug regulator, better watch out.

The FDA's latest move needs to be watched closely. It has announced the creation of an Office of Pharmaceutical Quality with effect from January 2015 within the Center for Drug Evaluation and Research (CDER) of the FDA.

"We are working to establish risk-based measurements that identify quality issues more rapidly and enable us to respond quickly before they become major, systemic problems," says a note on the FDA website by Lawrence X.Yu, acting director of the CDER.

"We will use performance measures to help us know the current state of quality of both facilities and products. With this information, we can make better decisions on when to conduct surveillance or take regulatory action if a company demonstrates a pattern of being unable to achieve quality standards," the note adds.

Companies globally and in India will spend the next few days and weeks trying to read between the lines and figure out any unstated messages by the FDA.

Indian drugmakers, some of whom have been under the scanner of the FDA and pulled up for quality and manufacturing practices, are trying to figure out the implications in terms of the approach of the FDA in its inspections.

DG Shah, Secretary General of the industry group Indian Pharmaceutical Alliance, says: "While the emphasis on quality is clear, we are trying to understand this further and our question essentially at this point in time is to understand if there is any shift in focus as far as the FDA is concerned and is there a departure from the past practice of emphasis on data integrity issues."

Shah added that while data integrity is also part of quality because "without data integrity you cannot have good quality, so is this an attempt to balance the two... we are trying to understand this and are seeking meetings with the FDA."

The position that most pharmaceutical companies in India seem to be taking is that the FDA should be an enabler of quality and not have an attitude of criminal investigation.

The common complaint is that FDA inspections have become quite forensic now and not quite science-based, as it ought to be.

But what seems clear to many is that this is a clear effort on behalf of the FDA to showcase itself as an entity devoted to patient safety and quality.

In this context, may be worth looking at the note put out by Lawrence X.Yu.

The note, titled 'From our perspective: Patients deserve quality medications' says: The Office of Pharmaceutical Quality (OPQ) is a "response to the need for a robust regulatory quality oversight program in a changing industrial environment. OPQ intends to be a global benchmark for regulation of pharmaceutical quality."