Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down. 

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner. 

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel. 

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy? 

Oh…my…God… 

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval. 

It should be noted that the FDA employs a fast-track route for approval if it is determined an applicant’s device is substantially similar to those already on the market. It allows such a manufacturer to escape the rigors and delays of further detailed testing, affording a more rapid approval and the resulting shortcut to market. 

ReGen noted that Menaflex had been approved and used successfully in Europe for almost a decade without safety concerns. 

However, the FDA reviewers were not placated. They argued that Menaflex was so substantially different than other products that more testing was required. The fast-track approval process should not apply here. 

So what happened? 

According to the investigative report, four sitting Democrats from New Jersey who had all received what were described as ‘significant’ campaign contributions from ReGen pressured the FDA and its commissioner at the time, Dr. Andrew C. von Eschenbach. The latter is said to have intervened, and overruled the findings and concerns of his own reviewers. 

The report concluded that the former Commish had become inappropriately involved in the decision, and that agency procedures had been bypassed. 

ReGen is based in Hackensack, New Jersey. All five men said that they acted properly. 

Give me a break. 

That would be like a surgeon wanting to do an operation you don’t need just because he needs to make payroll at the end of the month. That’s like a judge throwing a murder trial out of court because the accused lives next door to him and he just couldn’t imagine locking up a valued neighbor for life. 

It’s like the cop who let’s you off the hook for running a red light and putting lives in jeopardy because you’re a friend of his. 

There are vocations and organizations that need to be beyond reproach. The FDA needs to be one of them. 

If there is any good news here, it is that the FDA subjected itself to scrutiny without attempting to hide anything after the fact. Gardiner Harris, writing in the The New York Times, makes the point that the FDA had “never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.” 

So this is a start on the journey towards reform. That said, in order to avoid any and all undue influence in the future, the FDA has a long way to go before they get there…

Tags: FDA, implantable knee patch, Menaflex, NJ, ReGen

This was posted on Friday, October 22nd, 2010 at 10:04 am and is filed under Defective Products, Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.