Although several millions of doses of numerous generic prescriptions drugs were unexpectedly pulled from the market in a massive drug recall over one month ago, neither the FDA nor the manufacturer have come forward with any information to explain the matter.
On May 19, Able Laboratories stopped all shipments of its products. Four days later (May 23), Able took the highly unusual step of recalling its entire product line and suspending all manufacturing; something experts cannot recall having ever happened previously.
Able also withdrew seven approved applications to market various medications. Its Chairman and CEO also resigned.
The only reason Able gave for its actions was deficiencies in its testing procedures may have resulted in “sub or super potent” drugs.
With no products to sell and no manufacturing being done, the value of Able’s stock immediately plummeted by 85%. On May 27, Able announced 200 job cuts.
Over the past 14 years, Able has had many problems with the FDA including: over 10 drug recalls; charges of selling medications which were either adulterated, mislabeled, or with incorrect potency; failure to report serious adverse reactions with respect to at least five drugs; improper extension of drug expiration dates without proof the drugs would still be effective; and selling drugs with the wrong package insert.
Able has received a number of FDA warnings with respect to these deficiencies and it is unclear what measures the agency will impose with respect to the company’s latest revelations concerning deviations from proper manufacturing practices.
A full list of the recalled products, with identifying tablet imprint codes or liquid formulation lot numbers, is available at: http://www.fda.gov/oc/po/firmrecalls/qualitycare06_05.html. Additional information concerning Able Laboratories can be obtained by calling 1-888-463-6322.
Although the FDA later attempted to justify the one week delay (May 27) in advising the public of the massive drug recall as reasonable under the circumstances, many experts as well as consumer groups found the excuses to be unacceptable.
Dr. Sidney M. Wolfe of Public Citizen found the delay to be particularly troubling in light of the fact that the massive recall was based on what the FDA itself stated were “serious concerns that they (all of Able’s products) were not produced according to quality assurance standards.”
The FDA took the position that the additional time was needed to coordinate the voluntary recall with Able Labs and to prepare and publish a complete listing of the recalled drugs on the agency’s website at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html.
In a related recall, the FDA and Quality Care Products LLC, a federally licensed drug repackaging company, notified consumers and healthcare professionals by letter of a recall of all repackaged Able drug products.
As truckloads of recalled drugs were brought back to the company, Able saw its stock drop 86% in value since mid-May. Additional layoffs were announced on June 9 cutting its workforce by over 50%. Its profits for the first quarter of 2005 had been up 25%.
Able has made no prediction as to when, or even if, production will resume. Its plan to open a new plant that would triple its production is now in question.
All of this highly unusual activity is also raising serious questions as to the FDA’s enforcement procedures since Able passed 11 plant inspections in the past 3 years without mentioning any serious concern about the company’s manufacturing practices, and new-product approvals.
The FDA also approved Able’s applications to make 25 new generic drugs since 2001.
Now, without Able or the FDA clarifying the situation, both have advised patients to keep taking their medications until getting new ones from their doctors since abruptly stopping many drugs can be more harmful than taking the ones that were recalled.
Of course, that raises the question of what is really wrong (or thought to be wrong) with the entire product line that was pulled from the market? Obviously, the drugs are not suspected of being so compromised as to make taking them a life-threatening risk. Yet, only something relatively serious could prompt such an unprecedented recall of an entire product line and suspension of all manufacturing.
Clearly, the public, and especially Able’s patients, have the right to far more information than they have received so far.