In light of the pro-generic tilt of public policy these days the following sidebar from the Pharmaceutical Business Review might be of interest:
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
