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Sklamberg on challenges the US drug regulator faces globally

Last updated on: March 19, 2015 16:02 IST

The US Food and Drug Administration (FDA) says it does not follow an India agenda.

Howard R Sklamberg (below left), deputy commissioner, global regulatory operations and policy, FDA, tells Digbijay Misra and Nivedita Mookerji in an interview the origin of drugs does not matter to the regulator. Excerpts:

What is the view of the FDA on medicines made in India for use at home and for export? 

The view on drug and drug quality is that the standards around the world have to be the same.

Whether its New Jersey or New Delhi, when you are regulating drugs, the objective really is what is the quality and what is the effectiveness when it goes into someone’s vein.

It doesn’t matter which country the drug is coming from. We are not just applying that standard but keep working to ensure systems are in place for that.

Have the FDA’s concerns around Indian companies changed of late? 

First, there has been a big increase in the number of firms and number of products coming into the US.

So one of the problems, which we see in newspaper headlines, is a natural consequence of the number of medical products.

We do not in the FDA have a chart of problems per country.

It is focused on a firm and the quality it produces, irrespective of where it is located. There is no India enforcement agenda or India generic drug application agenda.

It is the universal drug quality agenda that the FDA has across the world.

When do you plan to appoint a permanent FDA head for India?
We are working on it. I don’t want to give a date as it depends on HR requirements and hiring. It is an important position and we are interviewing candidates. It is a priority to fill that position.

Indian companies complain about the FDA’s slow approvals. Do you plan to speed them up?

The commitment we entered in 2012 is for five years, to achieve the series of metrics and goals. We are on track to achieve that. In fact, I would say is we are on excellent path.

Ranbaxy has been under the FDA’s scanner the most. Now that Sun Pharmaceuticals is acquiring Ranbaxy, will things change? 

I do not want to talk about specific companies and actions. It is not fair to the companies. Our rules prohibit it. We meet with managements of companies across the board and that is same around the world.

Ranbaxy also dragged the FDA to court over the Nexuim generic. How does that change things for the regulator?

I cannot talk about specifics as I said.

When do you propose to roll out a policy of incentives for complaint companies and penalties for violators? 

We have not set a timeframe. We are working on it for the entire world.

What are the major challenges you have faced in India?

This is not just about India but the overall drug industry.

We have globalisation and the FDA has limited resources. We have to use our resources in a smarter and efficient way, which means to be able to identify which firms pose bigger risks, wherever they are located.

We have seen an increase in the number of companies and increase in number of products. Our challenge is to look through the universe and pick out the area where we have to focus most.

Digbijay Misra and Nivedita Mookerji
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