Children’s Motrin: Another Example of a Toothless FDA

September 24th, 2010. By Hunter West

A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities. 

The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth. 

As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.” 

According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall. 

There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences. 

Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all. 

Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall per se but a simple, voluntary recall by a manufacturer when a minor problem has been identified with a product not tied to the company’s manufacturing or distribution practices. 

Those are the four levels, and the Motrin issue landed in the middle at Level 2, according to the view of the FDA. In other words, the FDA expected the company to issue a Class 2 recall of the product. 

Instead, J&J appeared to be doing a market withdrawal instead, through the removal or ‘buying back’ of product from store shelves. 

This appeared to get the FDA in a snit, according to documents presented to the Committee on Oversight and Government Reform in Washington. 

“It seems that your company is doing a recall even though you are calling it a ‘retrieval.’ The agency’s position is that your company should do a voluntary recall of the product since it appears that you already are doing a recall of the product,” Neisa Alonso an FDA investigator in San Juan, Puerto Rico wrote in an email to a J&J executive dated July 16, 2009. 

Alonso went on to say that the problems with Motrin that J&J had identified to the FDA—and in fact, brought to the FDA’s attention voluntarily—typically result in a formal product recall (again, in this case in the FDA’s view, a Class 2). 

But that wasn’t done. And the FDA wanted to know why. 

There may be an answer for that. According to CNN Money on 09.21.10, the congressional hearing investigating J&J’s drug recalls produced documents that seemed to suggest J&J might have done the soft market withdrawal with the FDA’s blessing. 

In an email dated May 27, 2009 and copied to McNeil president Peter Luther, a McNeil executive wrote: 

“We have negotiated agreement with FDA not to formally conduct a recall for Motrin 8’s but rather conduct a ‘soft market withdrawal.’ This is a major win for us as it limits the press that will be seen. We had committed to FDA to complete this withdrawal by July 15th.” 

The FDA is adamant that this wasn’t the case, saying that it prompted a full, nationwide Class 2 recall after the agency learned of J&J’s market withdrawal effort. In the meantime, CNN Money reports, consumers were never informed about the recall / withdrawal. No press releases were ever issued. 

The FDA countered, late Tuesday of this week, with a statement of its own. 

“Any effort to suggest to the contrary is based on quoting documents selectively and out of context and ignores other evidence as to what occurred,” the statement said. 

“When the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall which the company agreed to initiate in July 2009. FDA then voiced its objections about McNeil’s ‘phantom recall’ activities to the senior leadership of Johnson & Johnson in a February 2010 meeting,” the FDA said. 

J&J / McNeil was asked to provide proof of its agreement with the FDA. 

Meanwhile Bill Weldon, the CEO of J&J, appears on a Fortune magazine video with Geoff Colvin apologizing for the way his company handled the withdrawal of the product. 

Did the FDA give permission for J&J to do a soft, quiet, on-the-downlow market recall of product (that kept consumers in the dark) in spite of the agency’s own recommendation for a Class 2 recall? We may never know. 

However, here again is yet another example of why the FDA needs to be reformed, re-designed, re-thought. 

Fact: the FDA does not have the power to mandate, order, require or demand a recall. All it can do is issue ‘guidelines’ for response. It’s really up to the company. Even if the FDA’s alleged agreement to allow J&J the market withdrawal is proven to be false and the manufacturer is found to have ignored the Class 2 recall request, there is northing that forces the company to comply. 

This is our national drug regulator? The drug police? 

Really… 

That’s like a cop happening upon a heist at a jewelry store. “We recommend you come with us downtown, submit to being arrested and a charge for the crime you are committing… 

“But you don’t have to. It’s just a recommendation. A guideline.” 

What crap. 

As long as the FDA is set up the way it is, the drug companies will do what they bloody well want. Wouldn’t you? They only thing drug companies are afraid of is the court of public opinion, and rightfully so. If the public suddenly started viewing the drug companies as animals and refused to buy their products, things would change in a hurry. 

That’s a deterrent. 

And product lawsuits. That can be a deterrent too, with one caveat: so long as the lawsuits cost the company less in payouts and legal fees than the drug is raking in, lawsuits can be little more than a cost of doing business. Not really a deterrent at all. 

But the FDA as a deterrent? Puh-leaze… 

True, no manufacturer worth its salt wants the FDA mad at them, lest the agency is still festering when it comes time to approve a new blockbuster drug. But then, if a proposed drug meets all the criteria, is deemed safe and effective and would prove helpful to the targeted patients, then shame on the FDA for not approving it just because it’s at war with a manufacturer. 

The Obama Administration’s much-ballyhooed reform of Health Care missed a major player when it looked past the FDA. Save for putting a no-nonsense individual at the helm, the latter is restricted by the powers—or lack thereof—granted to her organization. 

The FDA is the nation’s drug regulator with little power to effectively steer, or reign in a wayward drug manufacturer. 

Its nuts. 

Until that gets fixed, and until the FDA is given some real teeth, the safest drug you take remains the drug you don’t take at all…

Tags: Children's Motrin, FDA, J&J, Johnson & Johnson, McNeil

This was posted on Friday, September 24th, 2010 at 1:50 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.