A Ranbaxy Recall? Some Say Meds Should Go
7 CommentsBy Ed Silverman // September 19th, 2008 // 10:17 am
Why? Earlier this week, the FDA issued an import alert that allows authorities to stop Ranbaxy drugs and ingredients from entering the US, and issued warning letters for failing to meet manufacturing standards at two plants in India. And the Justice Department alleges Ranbaxy used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors (back story here and here).
Nonetheless, the FDA says its move has nothing do with drugs or active pharmaceuticals ingredients made at Ranbaxy’s other plants, which the FDA has inspected and determined meet requirements for drug manufacturing. In fact, the agency recommends consumers continue taking their existing Ranbaxy meds and “not disrupt their drug therapy, which could jeopardize their health.”
But not everyone agrees. “If it’s serious enough for them to issue an import alert, they should take product off the shelves and remove product from the distribution system,” says Anne Patenaude, who heads Prevent Medical Error, a non-profit that advocates for better medical practices. “Right now, in distribution channels, you may have three months worth of supply.”
And Holly Henry, president elect of the National Community Pharmacists Association, says: “I think a store recall may be justified. I probably wouldn’t dispense anymore Ranbaxy products if we can replace the stock…At this point, let’s just pull all the Ranbaxy products, just to save face with my patients…I would agree the right thing is for the manufacturer to do a store-level recall and give all pharmacies credit for their inventory…This alert is a concern. My advice to my pharmacists is we better stop dispensing this stuff.”
An FDA spokesman writes us this: “We are acknowledge the concerns you raise about products in the marketplace…As we explained in our documents released on Monday, we are concerned about the firm’s overall manufacturing and quality control procedures at theses facilities, however we do not have evidence to date that defective products not meeting their specifications were shipped from the affected plants.”
The House Energy & Commerce Committee, you may recall, believes the FDA was slow to act (back story) and is now scrambling, in part, to compensate for the Heparin debacle.
What do you think?
Should Ranbaxy drugs be recalled?
- Yes (79%, 130 Votes)
- No (21%, 35 Votes)
Total Voters: 165
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Salmon
I’m not sure if the FDA has the authority to issue a recall. If it does it has to be in the FDAAA 2007 law.
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
Ed Silverman
Hi Salmon,
Thanks for the info, but the manufacturer could issue a recall, yes? Also, Daiichi hasn’t yet finalized its purchase of Ranbaxy.
Salmon
Thanks Ed.
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
Rich
What is the point in bothering to comply with GMPs if the FDA will let your products be sold for years despite complete stonewalling on inspections.
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.
Ed Silverman
Hi Salmon,
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
Vikas Dandekar
Hi,
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.
James
Short answer–yes, the FDA does have recall power over GMP violations under FDAAA.
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.