USFDA commissioner's comments raise new hopes for Indian pharma

The past few days have been a mixed bag for the Indian pharma industry. There have been fresh concerns related to the transition to a Goods and Services Tax (GST) regime. Then, the industry lost one of its leaders - Desh Bandhu Gupta, the 79-year-old founder and chairman of Lupin.

There was also renewed interest on the implications for pharma from the visit to US by the Indian Prime Minister and the questions that might come up in the discussions at the meeting between Donald Trump and Narendra Modi. The industry was focusing on the extent to which the two leaders would go beyond the larger issues around climate change, terrorism or may be defence procurement and look at industry specific issues that have implications for pharmaceuticals - be it on pricing or intellectual property.

However, there is another development that the Indian pharma industry may want to track closely. It would be the follow up to the views of the US Food and Drug Administration (USFDA) Commissioner, Scott Gottlieb, shared recently. In his observations on the USFDA blog, titled "FDA Working to Lift Barriers to Generic Drug Competition", he makes two significant comments for the generic drug industry.  One, he says: "We're working on a Drug Competition Action Plan. As part of this effort intent to hold a public meeting on July 18, 2017, to solicit input on places where FDA's rules - including the standards and procedures related to generic drug approvals - are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended." The second observation that many, within the industry feel is reflective of his understanding that other than competition, there are several other factors as well which are very significant for drug pricing.

For instance, he says, "We're also going to be looking hard at how best to coordinate with the Federal Trade Commission in identifying and publicizing practices that the FTC finds to be anti-competitive. FDA is not the FTC (Federal Trade Commission). It is the FTC's responsibility to prevent anticompetitive business practices." Most pharma companies for instance talk of the changing landscape of wholesale buyer market in the US and that would also be a factor in deciding the pricing of generic medicines. For instance, there has been a consolidation among the wholesale buyers of generic drugs in the US. There are today about four large wholesaler chains that source generic drugs compared to about a dozen four years ago. One may know more once details are available on the public comments that are being sought by the regulator.

Source: http://www.businesstoday.in/opinion/alchemy/usfda-commissioners-comments-raise-new-hopes-for-india-pharma/story/255895.html