FDA awaits J&J plan for Tylenol

Today is the day by which Johnson & Johnson promised to submit a detailed action plan to the FDA on how it will fix the manufacturing shortcomings that have led to multiple Tylenol recalls. Such a plan would likely include a recap of what it's already done in the way of management and process changes. Also included might be action items identified by the consultancy the drug giant hired to assist in its manufacturing/QA overhaul.

Among the latter, we hope, are going-forward procedures for J&J's use of wooden pallets, which the company places at the core of the recalls. The TBP-to-TBA chemistry lesson that usually accompanies mention of the pallets in the Tylenol case may be a bit of a smokescreen for questionable ops processes. Healthcare industry consultant Donald Riker, president at On Point Advisors, believes the pallets were sprayed with bleach, dispersing the contaminant into the air and onto the walls and ceiling of plant. In an interview with FiercePharmaManufacturing, he says in an interview it's well known that bleach can convert the TBP in the preservative used on the pallets to the contaminant TBA. From the air, walls and ceiling, TBA could have traveled to open containers of product packaging in the Puerto Rico plant.

A solid J&J plan that includes process detail--including admin and record-keeping actions to shore up inventory tracking so that it no longer "inadvertently omits" some lots in future recalls--may go a long way toward providing the FDA with a sense that the company is serious about the GMP fix-up. It might also help explain how and why J&J chose which lots to recall, leading to what Riker calls a "rolling blackout" of the Tylenol brand.

A boost to FDA's confidence in J&J is likely the best hope the drugmaker has at this point of forestalling a consent decree and perhaps executive prosecution, tools that remain at the regulator's disposal. The consent decree is a measure that the FDA resorts to only when it believes it has "run its course with the company and hasn't gotten the response it wants" in terms of urgency around safety matters, says Jim Prutow, a partner in consultancy PRTM's healthcare practice, in a phone interview. Although no serious complications or deaths have been caused by the contaminated products, Prutow believes there are some safety issues with the recalled meds, especially given their target market of primarily infants and children. - George Miller

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