Want to find out about drug recalls when they happen? It seems FDA may need to get more involved. That may be one lesson to take from last week’s announcement that in August, Pfizer recalled 191,000 bottles of Lipitor after several patients reported a musty odor. Though it’s link to the Lipitor complaints is yet unconfirmed, a Pfizer test revealed low levels of 2,4,6 tribromoanisole in one of the lots, the same chemical used to coat wood shipping pallets that was linked to the delayed recall of millions of bottles of J&J’s Tylenol last winter.
Under current rules, companies that recall medications do not have to tell the FDA about a recall at all, much less within a certain timeframe. Though companies are required to notify the agency of chemical or physical changes, deterioration or contamination, J&J’s delayed recall and FDA notification (the company started receiving consumer complaints of musty odors in early 2008) suggests that even that reporting rule may be broadly, or loosely, interpreted by companies.
Pfizer has indicated that the recalled bottles of its blockbuster cholesterol medication came from a third-party supplier, but would not name the supplier or its location. A spokesman for the company told in-pharma Technologist that it is working with the FDA to “[change] the way that the bottles are packaged at the bottle supplier, decreasing time to delivery, and relocating some bottle production to other facilities operated by the supplier.”
Without sounding like a broken record (or an iPod on repeat), the amount of irregular, voluntary, and sometimes significantly delayed public notice of drugs pulled from the market is stacking up faster than it should, at least for the comfort of those on the public side of the equation. Drugmakers’ conflict of interest – that is, a fear of potential sales lost by telling the public the full and timely facts about why, where, and when a drug was recalled – may be just too great to overcome with cautionary tales and promises at Congressional hearings to do better.
The FDA, free of that conflict and charged first with protecting the public’s health, is a fundamentally better steward of a recall, setting requirements for timeliness and disclosure, and overseeing–not just reactively advising–a company on when and how to remove risky drugs from the shelves. Several bills before Congress would give FDA that authority, and the Lipitor recall joins the list of reasons to give them consideration.
For more, see PostScript’s drug safety archive.
–Kate Petersen, PostScript blogger