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.
Comments
Post a Comment