Manufacturing deficiencies cited by FDA inspectors

The public, via consumer complaints about certain over-the-counter children’s medications spurred the investigation that led to a recall of more than 40 different products because of manufacturing problems, according to officials at Johnson & Johnson. McNeil, a division of Johnson & Johnson, is recalling 43 over-the-counter medicines made for infants and children — including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl — after federal regulators identified what they called deficiencies at the company’s manufacturing facility. The voluntary recall was announced late Friday by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries — a vast portion of the children’s medicine market. FDA inspectors had begun a routine inspection April 19 in the company’s Fort Washington, Pa., plant when they noticed “manufacturing deficiencies” that triggered the recall according to senior FDA officials.

Parents are urged to consider generic versions of Tylenol (acetaminophen), Motrin (ibuprofen), Zyrtec (cetirizine), and Benadryl (diphenhydramine).   Most doctors are recommending switching to a generic rather than stopping a medications altogether. As always, parents should first check with their children’s doctor or office for advice on how to proceed.   Parents are also warned NOT to substitute herbal remedies or baby aspirin for Tylenol or Motrin.  Herbal supplements aren’t tested or approved by the FDA. Aspirin carries a risk of a rare, serious disorder (Reye’s syndrome) when used by children and teens. Under no circumstances give medications meant for adults to children. Pill splitting will give a child too high a dose that could cause serious complications.

This latest episode, along with previous recalls of medications are leading to some probing questions. First, what is being done to ensure quality control in the mixing, preparation, manufacturing and packaging of brand medications – both prescription and over the counter?  Second, does a brand name drug suggest that quality is better than a generic?

It appears that the answer to the first varies among manufacturers.  Although all are signed on to standards from the FDA and other federal agencies, oversight is left to private companies where laxity could be an issue.  Because of a remaining stigma some still attach to generic medications, most generic manufactures employ manufacturing processes that exceed FDA requirements.  Overall, the growth of generic drugs has boomed since the mid-1980’s when the Hatch-Waxman Act was passed.   Here are some facts about the current generic drug market in the United States:

• Three-quarters of total prescriptions dispensed were branded and unbranded generics
• Through 2014, $89 billion are at risk to generic competition
• Generic medicines saved the American health care system more than $734 billion from 1999 to 2008, with approximately $121 billion in savings in 2008 alone
• Generics save $1 billion dollars every three days
• A 3% increase in the national overall generic utilization rate could yield approximately $10 billion in additional savings, $1.4 billion for the Medicaid program alone

Suffice it to say that brand manufacturers bear the brunt of research and development costs for new medications, costs which can often run in the hundreds of millions of dollars.  Having said that, it is clear that brand manufacturers do not hold a patent on quality control when it comes to manufacturing. The latest recalls attest to that.  No doubt the FDA and other agencies will crack down, as they should, on oversight of manufacturing quality control processes at all pharmaceutical plants nationwide.  We hope that this latest problem will awaken all drug manufacturers to re-double their efforts at quality control throughout the drug manufacturing and delivery process . . . obi jo and jomaxx

http://www.associatedcontent.com/article/2962022/massive_recall_of_childrens_medicines.html?cat=25

FDA NEWS RELEASE: FDA provides consumer advice following recall of products for infants and children – http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210441.htm

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products – http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc

Johnson & Johnson division recalls 43 OTC medicines for infants and children – http://www.washingtonpost.com/wp-dyn/content/article/2010/05/01/AR2010050103051.html

Children’s Tylenol and Other Drugs Recalled – http://www.nytimes.com/2010/05/02/business/02drug.html?src=busln

J&J’s McNeil Recalls Some Infant’s, Children’s Liquid Medicine – http://www.bloomberg.com/apps/news?pid=20601202&sid=aAabdyHmRxl0

Johnson & Johnson Recalls Children’s Medicines – http://online.wsj.com/article/SB10001424052748704608104575218154165958476.html?mod=rss_Today’s_Most_Popular

Children’s Tylenol recall: Parents wonder what to do – http://www.chicagotribune.com/health/ct-met-childrens-tylenol-0503-20100502,0,1782009.story

Consumers Helped Spur J&J Recall of Children’s Medicine – http://online.wsj.com/article/SB10001424052748704608104575220420101711154.html

Rethinking Generic Drugs vs. the Brands – http://www.nytimes.com/2010/05/03/business/03drug.html?scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt

Managing Quality in the Generic Drug Supply Chain – http://www.uspharmacist.com/CMSDocuments/2010/4/Managing_Quality.pdf

Drug Price Competition and Patent Term Restoration Act – http://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act

Recall Product List – http://www.mcneilproductrecall.com/images/mcneil_recall/Final_list.jpg

McNeil Consumer Healthcare: Product Recall Information – http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc

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