Ex-U.S. contracting may be Tylenol's path of least resistance

No matter how much money and horsepower you throw at it, pharma plant remediation is slow. The recent Wall Street Journal report disclosing Johnson & Johnson ($JNJ) had begun shipping Tylenol Cold & Flu Severe caplets after two years of incessant recalls has been confirmed by the company. But J&J would not say whether the products are being made in Italy, as the newspaper asserted.

Getting contractors or other of its own plants up and running to begin producing the many Tylenol products still absent from store shelves is no doubt a priority for J&J, especially with flu season fast upon us. "McNeil plants being gutted and recertified leave limited capacity," says Donald Riker, president at healthcare industry consultancy On Point Advisors.

Each contractor and facility J&J chooses will have to undergo GMP assessment by the FDA. In addition, J&J would be unwilling to use the plants of companies like Perrigo, which produce store brands in the U.S., he explains in an email.
 
But, alas, the good Tylenol news was followed within days by a J&J recall of its Eprex anemia drug. It's calling back some 200,000 syringes because some batches may be insufficiently potent, reports the Wall Street Journal Heath Blog. The recall involves products in 17 countries--including the U.K. and Canada--but not the U.S.

- here's the WSJ story (sub. req.)
- see the Health Blog item

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.