J&J: Out from the Ashes---Not.

Johnson and Johnson gutted and retooled their Fort Washington facility to come back with a bang with the launch of a new bottle designed for its grape flavored infant liquid Tylenol to guard against accidental overdosing. But instead of accolades, complaints poured in about the protective cover pushing loose when the dosing syringe was inserted. The first new product out of the new facility was added to the long list of recalls that has knocked the once respected Tylenol brand off its pedestal.

One does not need to be a rocket scientist to understand the failure mode of a problem of the plastic protective cover pushing loose when the dosing syringe in inserted. But it does take technical knowledge of different types of plastics used in pharmaceutical packaging and how variation is controlled for plastic molded parts. People actually go to school and learn about this stuff and how to apply this science to real-world pharmaceutical applications.

So what happened at J&J?

I don't have insider information, but one can only assume that there were no real packaging or quality engineers to be found. Or if they were, they were incompetent. If they were not incompetent, then they kissed their science good-bye---probably under pressure to meet the almighty new product launch date.

Who knows? I'm just reading the tea leaves. All I really know is that J&J blew a huge opportunity to come back with a great packaging concept that veterinary product manufacturers perfected a long time ago.

I am very sad for J&J.

The QA Pharm

Drug Shortage: A Story of Self-Inflicted Management Tragedies

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time it is the drug to treat acute lymphoblasic leukemia, which most often strikes children ages 2 to 5.

The article quotes the president of the American Society of Clinical Oncology saying that he hopes that the FDA's hard work can help avert a crisis. The FDA is always brought into the middle of the political quagmire of pharma companies, medical professionals and patients. But the FDA is not the "bad guy."

If you were to map the drugs that are in short supply to the FDA's Inspection Observations, Warning Letters and Consent Decrees, you will find a long history of problems that would have given any reasonable management plenty of time to permanently solve the problems.

The truth is that the problems are self-inflicted. There is not one problem that cannot be solved with the right management and the right technical and scientific expertise to establish a capable manufacturing process and facility.

Quality Assurance is not totally off the hook. Often QA cannot see the forest for the trees. They strain the gnat and swallow the camel. Often they are busy policing the proper use of indelible blue ink that they do not see the cumbersome, non-value-added administrative activities that are choking the quality management system.

I read Mr. Harris' article and though of my healthy grandchildren. Thank God.

My heart goes out to those patients who are dependent on life-saving drugs.

C'mon people get your act together!

The QA Pharm