It's Time To Pick on The FDA............Again

It was reported on February 21st, that the House Energy and Commerce Committee planned on scrutinizing the FDA's device approval process, so that the regulatory process does not force U.S. jobs overseas.  Joe Pitts (R) PA, aka as "the Pittstop," recently blogged on "The Hills," that he and his panel want to explore why Europe has gained an advantage over the U.S. TSB must ask Congressman Pitts, where have you been for the last twenty years?  No one ever accused Mr. Pitts of being a medical device expert, considering that he was a math and science teacher before venturing into public service.  Pitts believes that medical device jobs are great.  If he truly believe this, maybe after he is done investigating the FDA, he could start on POD's.  His goal is to make America safer and stronger.  As medical device manufacturing continues its exodus off shore, the question must be asked, is medical innovation truly being destroyed by bureaucracy, or is this just part of a larger problem?

What has provoked this inquiry was CDRH's Director Jeffrey Shuren's comments on February 17th in front of the House Subcommittee that "the (medical device) industry should take more blame for review delays." Obviously, this comment along with his comment that "the U.S. does not use its people as guinea pigs," has raised the ire of many a CEO and entrepreneurs.  As stated in previous blogs, the FDA has plenty of its own challenges.  These challenges run the gamut, from being nothing more than a training ground (attrition) for corporate America, to being overworked and inundated with submissions, to offering a paltry salary, to inexperienced reviewers.  But what about the industry?  Accountability is a two way street, whenever two parties are involved, and that's where the problem lies, and that's why we are at an impasse.  Dealing with the FDA is black and white in terms of transparency, and please spare TSB the rationale that corporations never ever do anything wrong. If we want the FDA to exhibit more speed and transparency, maybe its time that the FDA scrutinize and report back to the Captains of Industry how inefficient some of their employees really are.  It's always interesting to read another websites position on this, considering it is always slanted toward the industry.  God forbid questioning some of our practices.  The efficiency of some 510(k)s is questionable at best.  Lack of clinical knowledge, not knowing predicate devices, and at times comparing it to the wrong devices.  In addition, how many companies have attempted to massage testing data only to have to go back and do it all over again?

Maybe Josh Makower should spend some time analyzing why some of the companies that he surveyed took 2-3 years to get their products to the market.  Considering that time to commercial market is of tantamount importance to any investor, how much of his position is influenced by his investments?  But let's discuss the truth.  The truth is that at times, bringing an emerging technology to market is more art than science.  There are multiple variables going on simultaneously during each project with a unique DNA or blueprint depending on the product or drug.  Most entrepreneurs are focused on one thing and one thing only, time to market and ROI, and anyone that denies that is an outright BS artist.  It's acceptable to deprive a physician and patient a product, if it means safety comes first.  I wouldn't expect anything less than an entrepreneur complaining that time delays innovation, because time is money.

Considering that the government is looking to cut funding across the board, how much leaner can agencies like the FDA get?  Who will determine what a breakthrough device really is, if we ask people to work longer hours, with less experience, with less resources?  Some Congressman who is being greased by special interests?  Privatizing the FDA?  In deference to Jeffrey Shuren, how many of us have sat at meeting in the past and viewed surgeons doing three or four level artificial disc replacements only to have to revise the procedure because the disc spit out or retropulsed, only to find out that this was done south of the border?  How many times have we sat and listened to some surgeon discuss dynamic stabilization only to shake our heads in amazement because the talk was so esoteric that even the surgeon himself did not know what he was looking to achieve?   It has become in vogue to kick and scream at the government, regardless whether you are a democrat or republican.  But what about our own accountability when it comes to doing the right thing?  Remember, as long as it isn't your mother or father, sister or brother, son or daughter or best friend, the reality is that most of us only care about the benjamins, until its your turn, and then it becomes a different story. So, in the spirit of debate, what are the solutions?  We know the challenges, and contrary to industry and investor cheerleaders like Makower, what are the legitimate solutions?  TSB wants to know what you think?