Longer answer–Unless new information comes to light, they likely won’t issue a recall in this case, since they are just getting their arms around what FDAAA means. They will probably want to exercise other options, e.g. the import hold, if it accomplishes the goal. Recall would be one of the last resorts.

I base these conclusions on public statements FDA officials have made. I am not an FDA employee or a lawyer.

I really liked the analysis of the current mess that Ranbaxy is in. Just wanted to add that Ranbaxy did a voluntary recall of its Gabapentin drug last year. No reason was stated at that time for the recalled batch.

A belated reply. And as to Daiichi, I would tend to agree they may have a perception problem, among other things, but only if they proceed with the purchase. If they walk away, for instance, well that would be something else.

Regards
ed

If a US-based manufacturer tried to do this, US marshalls would be kicking down doors within months. Pearl River was raided for far less serious offences - there was no intentional cover up there.

Public safety depends on companies complying with the law, and being completely open with inspectors. Perhaps inspectors shouldn’t nit-pick too much and cause needless cost, but falsifying testing results and concealing fraud has to show a clear intent to distribute products of poor quality.

The FDA says that they have no evidence that unsafe drugs are on the market. Well, of course they don’t - the company who would have that data wouldn’t tell the FDA if they had it (assuming they bothered to collect this data themselves as opposed to just making it up).

Do we need to have a melamine problem inside the US border before somebody starts taking drug quality seriously with foreign suppliers?

As far as being able to order a recall goes - why not simply tell Ranbaxy that if they don’t recall the products immediately their licenses would be suspended indefinitely and that the process to get them back would be a long one? Somehow I doubt the company would complain about issuing a “voluntary” recall to avoid a delay once the FDA is satisfied they’ve fixed their problems.

You’re absolutely right and I was remiss not pointing out that a company can issue a recall even if the FDA can’t order one.

As to the second point thanks for that correction also, However I think mistake actually highlights that even though Daiichi hasn’t finalized the purchase, in my mind (even if it was erroneous) and likely in the minds of others Daiichi and Ranbaxy are already linked and thus it is already effecting Daiichi’s reputation. So whether the purchase is complete or not, if Daiichi goes ahead with it I think they need to discuss with Ranbaxy how this situation is handled so as to minimize bad publicity for Daiichi.

Salmon

Thanks for the info, but the manufacturer could issue a recall, yes? Also, Daiichi hasn’t yet finalized its purchase of Ranbaxy.

Even so looking at the list of drugs and API’s I see a number that I would be quite concerned about (AIDS, Parkinson’s Disease, and specific drugs) if there were manufacturing problems. Even without evidence that specific lots that failed specs were not shipped, the very fact that fabrication of data and use of unapproved active ingredients (the drug itself) was occurring means that Ranbaxy was not following Good Manufacturing Practices (cGMP) which is a requirement.

Since these are generics there are plenty of alternatives available. In additiion, most generics are sold as loss-leaders so that pharmacies and wholesalers will buy a specific brand that also includes the couple of profitable newest generic drugs where all the money is made. Thus whether to recall or not is really more a matter of reputation. Thus the question for the company is will a recall worsen our reputation or will it improve it by showing we’re being proactive. If it were me I would not be purchasing any Ranbaxy generics and I would be returning what I had.

Since Ranbaxy was just purchased by Daiichi which is not a well known brand in the US I believe that if Daiichi doesn’t recall they will adversely effect their brand image that will be harder to make up. After all the initial problem may not have been their fault but by not doing anything with regards to a recall they’re in effect saying to the US consumer (and pharmacies) we don’t care about the patient or you. They should remember that a first impression is a lasting impression.

Plus Daiichi only came to the US a few years ago because they had a culture problem with getting drugs approved in the US and this was effecting their overall growth.

It’ll will be interesting to see what they do.

Salmon