Children’s Tylenol on the Hot Seat

The House Committee on Oversight and Government Reform held a hearing about the recall of about 40 types of popular children and infant Tylenol products made by Johnson &Johnson subsidiary, McNeil Healthcare.

Panel members on Thursday, May 27, discussed what little authority the FDA actually has in ordering a recall. Most consumers don’t realize that the Food and Drug Administration must work with the company, in this case Johnson & Johnson, before a recall can be issued. If J & J wants to be difficult, the FDA must then obtain a court order to get a recall and defective medications off store shelves. That means a delay. It is sort of like the tail wagging the dog.

On the other hand, to work strictly through the courts would also mean a delay at the risk of consumers. Rep. Jackie Speier of California asked the FDA’s Dr. Joshua Sharfstein if having stronger enforcement powers would help the agency. As the FDA tries to be more effective in inspections and enforcement that is the 800-pound elephant in the room, said Ms. Speers.

As it stands now, McNeil’s Pennsylvania plant that makes about 40 types of children’s cold and allergy medications is closed ever since FDA inspectors found holes in the ceiling, filthy conditions, and bacteria in the formulations. Of most concern was a lack of quality control. Some of the product was “super potent” and some had little active ingredient. This is just the tip of the iceberg for J & J.

The FDA even went out on a limb and told consumers not to purchase the McNeil/J & J brand and to instead purchase generics.

Before the plant reopens, the FDA will insist that manufacturing standards meet all requirements for health and safety, which should have been done all along of course. So far, no direct link has been established between the 40 types of medications and the 775 reported adverse events reported to the FDA, including 7 deaths.

Recalled medicines include – Motrin, Benadryl, and Zyrtec, along with Children’s Tylenol pain reliever and other mediations, in all, about 70% of the children’s over-the-market liquid medications. Jacksonville drug recalls injury attorneys will be monitoring what is noted as the largest recall of children’s medicine in the history of the FDA and the third for McNeil over the last eight months.