Rehash; FDA device inspections and the Guidant deal

August 31, 2017 – 11:30 AM | By Mark McCarty | No comments yet
Not your average FDA inspector

Atypical FDA inspector

As the summer doldrums draw mercifully to a close, we can look back over a more or less expansive period of time to see where we’ve been in some hope of divining where things might be headed. Or maybe it’s just fun to revisit the past. In any event, following are a couple of developments of interest in the world of med tech.

Device warning letters tank

In case you were wondering whether industry pressure on the FDA regarding device inspections was having any effect, the jury is more or less back and the answer is, “it sure seems that way.”

You can’t have a warning letter without inspecting something, even if it’s just a company’s website, and the warning letters FDA posted on Aug. 29 include none for device makers. The list for Aug. 29 includes a number of warnings for drug-related GMP issues, while the most recent device warning letter is the July 12 warning to Whitehall Manufacturing, a letter from the Los Angeles district office. This is one of only two device warnings listed for the month of July.

Is this a big deal? One might think so, given that there are at least 10 warning letters to drug makers (and a fistful at least to compounding pharmacies) in July, and seven in August. The reader might remember all the noise about FDA inspections of device manufacturing sites, which led to provisions in the user fee legislation dealing with device inspections. Looks like industry has had a pretty serious impact on the volume of warning letters associated with those inspections as well.

Blast from a decade past

Sometimes it’s fun to scroll back and see where things stood 10 years ago, and the Aug. 31, 2007 issue of BioWorld MedTech – which at the time was still known as Medical Device Daily – reported on the settlement arrived at between Boston Scientific and a number of parties in connection with the company’s acquisition of the notorious Guidant.

As reported by our executive editor Holland Johnson, BSX had acquired Guidant the previous year for roughly $27 billion in an effort to gain traction in the cardiac electrophysiology space after something of a bidding war with other device makers. That deal cost the acquirer dearly in terms of  headaches, even if it seemed like a good idea at the time, but fast forward to just 30 months ago and there’s a press release describing the $600 million BSX had to hand over to Johnson & Johnson for Guidant’s purported breach of a merger agreement with J&J.

Was the Guidant buy worth all the headaches for BSX? Tough to say. By at least one account, Boston Sci had taken a total of nearly $13 billion in write-downs for the deal just by the end of 2012, but there were also lawsuits and an IRS tab to manage. Let’s not forget about the patent spat with Mirowski Family Ventures, a case that cost the company in excess of $300 million and which came to an end when the Supreme Court declined to grant cert for the case earlier this year.

Some have characterized the Guidant acquisition as the second worst deal of the century, but it’s still a young century! And even if everyone at BSX has concluded it really was a turkey of a deal after all, people in my line of work got almost as much mileage out of it as I managed to wring out of the acronym “SGR” before Congress laid it to rest. But that’s another story.

Son of hanging chad?

And now for some lighter fare. The Aug. 30 Medicare advisory committee was interesting for several reasons, including that the equipment used to tally votes once again came through in abysmal fashion. There were a number of instances in which a panelist’s vote did not register, although a review of the equipment may or may not disclose a digital piece of flotsam stuck to the electronic equivalent of a punch card.

We’ve seen this with FDA advisory committees, and it’s strictly a question of pressing a button, which makes a digital counter go up by one. You wouldn’t think that getting something like this to work is a Wernher von Braun moment, but…

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