BioWorld

Goldilocks or bust: The FDA’s regulatory harmonization dilemma

Thu, 03 Feb 2022 15:00:00 -0500

We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA undertaking in a quarter century. Those who don’t follow these things might find the subject terminally boring, but such a change could be a massive headache for industry, although it doesn’t have to be if the FDA can get the temperature of this regulatory porridge just right.

Forward to the past: The FDA commissioner dilemma

Fri, 13 Aug 2021 12:00:00 -0400

As we’ve all undoubtedly noticed, the FDA commissioner’s chair is conspicuously absent a duly deputized occupant, and a number of reasons have been offered to explain that. Some of these, such as the COVID-19 pandemic, will eventually give way, but some of the drag is unrelated to temporary issues, which is the more worrisome part of the problem.

U.S. politicking threatens public trust in the FDA and CDC

Wed, 26 Aug 2020 12:00:00 -0400

The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.

The demise of the device tax and other fun med-tech stories

Tue, 07 Jan 2020 09:00:00 -0500

It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a blog with wisecracks about 20-20 vision in 2020. Still, there are a few things to look forward to in this new year, including some great expectations and one or two desperate hopes.

Missed Opportunity: The epidemic of poor sleep

Thu, 19 Sep 2019 11:29:00 -0400

There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of thing. Still, there’s a big opportunity to do just that if one demonstrates an interest in sleep, a subject about which there is little evident interest in Washington, D.C., or in the boardrooms of med tech firms. According to a study by the Rand Corporation, data from five OECD nations suggest that those who sleep...

Next up for TAVR: bicuspid valve

Tue, 27 Aug 2019 08:33:00 -0400

Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...

Cabanas and commissioners; med tech in the news

Thu, 30 May 2019 05:39:00 -0400

We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media. Cabana and the case for catheter ablation We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions...

FDA’s new man of regulatory mystery

Tue, 30 Apr 2019 18:29:00 -0400

Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under...

Scott Gottlieb and the FDA’s revolving door problem

Thu, 07 Mar 2019 08:09:00 -0500

Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it. Gottlieb had been on the job...

Four “Spooky” ways to fix the 510(k) dilemma

Thu, 13 Dec 2018 08:07:28 -0500

A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot 100, and eerie though it may sound, there might be a lesson in there for the FDA half a century later. Sound preposterous? Read on and decide for yourself. House (and Senate) on Haunted Hill As we’ve all seen, the FDA has proposed to pull the substantial equivalence standard for 510(k) filings, but the agency also acknowledged that these 510(k) submissions have ballooned over the past decade or so. Some of that...

Substantial equivalence revisited

Wed, 05 Dec 2018 10:57:22 -0500

When things go awry, we often hear the rather dubious claim that goes something like this: "I hate to say I told you so, but..." Truth be told, that's silly. We love being able to say we told you so. We're human! In that spirit, when it comes to the FDA's recent announcement about getting rid of the substantial equivalence standard for 510(k) devices, let me say this: I told you so. To recap, the latest set of FDA proposals regarding the 510(k) program, including a rather oafish doing-away with the substantial equivalence standard, have drawn a lot of ink...

NSE; Pre-cert and the fate of the 510(k) program

Wed, 29 Aug 2018 10:04:02 -0400

As device makers know all too well, the acronym NSE means not substantially equivalent, which is not the desired outcome in connection with a 510(k) filing. However, there’s another predicament that doesn’t look substantially equivalent, either. That’s the function of the FDA pre-certification concept and the 510(k) program as a whole. The reason this lack of equivalence is topical at this moment in regulatory history is that even a casual reading of recent tea leaves suggests that the agency is yet again on the march in an effort to excise the...

Pumping the brakes on med tech optimism ... or not

Mon, 07 May 2018 18:13:12 -0400

There's more to med tech than just money, but it's pretty tough to do much without it. Consequently, money is topical, but one expert sees a more difficult road ahead than anticipated for investors in digital health, while another says device makers are missing out on several opportunities to do their coffers some good on their way to market. Healthy skepticism over digital health Developers of digital health applications may be jubilant regarding the FDA’s efforts to modernize its approach to these virtual medical devices, but the new proposal regarding a full-fledged digital pre-cert program...

ACC 2018: Data for Heartmate 3 suggest a study against transplants

Sun, 11 Mar 2018 20:25:42 -0400

By Mark McCarty, Regulatory Editor Some devices are just the latest and best in class while others force clinicians to revisit long-held assumptions about the possibilities of a device type. This appears to be the case with an interim report of data from a study of the Heartmate 3 device, which not only handily bested the Heartmate II for freedom from disabling stroke at two years, but also prompted one observer to ask whether the time has come to try a left ventricular assist device against transplantation. Mandeep Mehra...

ACC 2018: Five-year Corevalve data closely track SAVR outcomes

Sun, 11 Mar 2018 11:19:53 -0400

By Mark McCarty, Regulatory Editor Five-year data for novel cardiology devices are often unavailable before that iteration of the device has become obsolete, but those data are nonetheless important. Hans Gustav Thyregod of Copenhagen University Hospital reported five-year data for the first two generations of the Medtronic Corevalve device, stating that five-year mortality for lower-risk patients, those with STS scores of less than four percent, were equal for the Corevalve and surgical aortic valve replacement. Thyregod unveiled the new data set for the first two Corevalve iterations at this year’s meeting of the American College of Cardiology, and he noted...

ACC 2018: ICD vest associated with lower all-cause death, but not SCD

Sat, 10 Mar 2018 18:35:15 -0500

ORLANDO, Fla. − It’s always difficult to explain why a device therapy reduces overall mortality without affecting mortality for the condition under treatment, but that’s the dilemma facing the trialists involved in the study of a lightweight defibrillator vest that tracks cardiac function. The Vest prevention of Early Sudden death Trial (VEST) presented just such a predicament, but the fact that many patients suffering an infarct are still subject to at least a 40-day waiting period for Medicare ICD coverage suggests that the Zoll Medical Lifevest will be well received by cardiologists for...

Carryover; Two 2017 Stories for 2018

Wed, 27 Dec 2017 09:52:49 -0500

2017 was quite the year in terms of device regulations, but payers had an interesting time of it as well. Following are a couple of developments that promise to carry over into the new year, with unpredictable consequences. Tapping the NTAP for more jingle Distracted by tax reform? You might have missed a couple of bills sponsored by Reps. Tom Reed of New York and Dave Reichert of Washington, and the question of Medicare spending on the new technology add-on (NTAP) program is suddenly topical. H.R. 4679, the Ensuring Equal Access to Treatments Act of 2017, would impose a number...

Small Changes; FDA and the 510(k)

Fri, 27 Oct 2017 10:25:23 -0400

Tom Waits once sang of a character named Small Change, who apparently "got rained on with his own .38," and device makers might sometimes have felt as though small changes to their devices didn't always work out so well, either. Waits is still among us, however, and the final 510(k) changes guidance is out. This effort to overwrite the K97 memo was no mean feat, although it was perhaps predictable that it would be a tough slog. After all, this guidance is easily one of the five most important guidances where FDA's regulation of medical...

Accelerated; Language and the New FDA

Thu, 19 Oct 2017 09:42:56 -0400

We've all been witness to a variety of predicaments in terms of the FDA's premarket review of biologics, drugs and devices, but while controversies abound, there's also this nagging question of how words color perception. It's an important consideration, one that legislators and government agency employees might want to carefully think through before committing things to print. A good example is the term "accelerated approval." This is a term the FDA has itself used, so its understandable when the agency's critics blast the FDA for its seemingly hasty review process...

Closing the Absorb chapter

Tue, 17 Oct 2017 15:37:14 -0400

Two years ago, my youngest child was just learning how to walk and analysts were praising Abbott Laboratories' bioresorbable vascular scaffold. Flash forward today - my son is riding his bike like a true champ (with training wheels) and Abbott is singing a different tune about bioresorbable stents. In fact, the Abbott Park Ill.-based company isn't singing any tunes about Absorb at all. Oh, what a difference two years can make. Earlier this month, Abbott announced that it was discontinuing sales of its Absorb stent - citing low sales as the reason. The news broke on a quiet Friday afternoon -...

Tempest Fugit; The 2017 MedTech Conference

Fri, 29 Sep 2017 08:42:28 -0400

This year’s med tech conference was a lot like previous years’ events, but the heat of the moment is always telling, isn’t it? Following are a few developments that were part of the conference by design or by chance, but the task of sorting out which will and will not leave a mark, as it were, is no mean feat. Lab test fee or a test of labs’ patience? The draft clinical lab fee schedule blew up just in time for the conference with a publication date of Sept. 22, which...

Is open source the future of pharma and med tech, or an anomaly?

Mon, 18 Sep 2017 19:16:59 -0400

Technology seems to leap ahead at an astounding pace and is disruptive for many businesses, but is achingly slow for patients who await disease detection and treatments. A recent TED Radio Hour, “Fighting Cancer,” included speakers who addressed their approaches to speeding the move toward more precise and faster-acting cancer diagnostics and targeted therapies. James Bradner of Dana Farber Cancer Institute, and president of Novartis Institutes for Biomedical Research, was part of a research team which shared the molecule they discovered to treat a rare form of cancer publicly. The normal steps after research of protecting the information and developing...

Rehash; FDA device inspections and the Guidant deal

Thu, 31 Aug 2017 12:30:20 -0400

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...

Second bites and second sights: A summer med tech trifecta

Mon, 21 Aug 2017 11:53:01 -0400

Rock and roll radio stations used to tout their two-for-Tuesday and three-for-Thursday lineups, but we at BioWorld MedTech think every day is good for a threefer. Below are three stories of recent vintage to grace the pages of BWT, at least one of which suggests that the FDA budget may be caught up in the next presidential election. All-user fee FDA not a reality … yet The Senate has passed legislation for the latest FDA user fee agreements, and President Trump signed the deal last week despite the President’s expressed preference for an...

Augmented reality check

Wed, 16 Aug 2017 10:14:18 -0400

My first real exposure to what's commonly called augmented reality was about a year ago when one of my former colleagues introduced me to Pokemon Go. I remember her telling me that you could actually hold up your smartphone or tablet and see actual Pokemon along the street. Now fast forward by a year, and most of the hype surrounding the game has waned off. However there is still tremendous enthusiasm with augmented reality. In fact reality altering technology isn't just regulated to Pokemon and the video gaming industry, it has invaded health care and looks to be more...

Tech reflects our humanity

Wed, 02 Aug 2017 09:46:05 -0400

When my now middle-aged dog was a puppy, I looked into taking him to basic obedience classes. At one of these sessions, a group of newbie pet owners gathered in a room tucked into the back of a pet store. Each came armed with a pocketful of treats or a clicker, hopeful to see results with their pet. As the class went on, some pets obliged their owner’s coaxing to sit or lie down, while others angled for treats. It quickly became apparent that much of the training that was necessary to make a well-behaved dog was actually on the...

Summer love; med tech 'court-ship' heats up

Wed, 19 Jul 2017 09:52:25 -0400

Louis Armstrong's Summer Song evokes an inviting and mellow season, but a leisurely pace can be a pain in the neck for a med tech writer. The FDA's device center might not be pumping out guidances of late, but the courts are always in business, providing grist for the mill even when federal government agencies seem to have fallen prey to the summertime blues. Forward to the past at CAFC Michael J. Fox had to go back to the future in a movie thusly titled, but...

Philips set to acquire Spectranetics for $2.2B ahead of Stellarex approval

Thu, 29 Jun 2017 14:24:00 -0400

Royal Phillips NV is set to acquire Spectranetics Corp. for €1.9 billion ($2.2 billion). The proposed acquisition is the latest in a string of efforts the Amsterdam, the Netherlands-based company has made to strengthen its position in health care. The deal is set to close in 3Q17. Upon news of the proposed deal, shares of the Colorado Springs based-company (NASDAQ:SPNC) were up on Wednesday by about 26.15 percent and trading at $38.35. Philips said the acquisition will further expand and strengthen its image-guided therapy business group, which was bolstered significantly by the company agreeing to...

Glooko closes series C with $35M in financing to improve lives of patients with diabetes

Wed, 28 Jun 2017 12:35:00 -0400

Diabetes data management company Glooko closed a series C funding round with $35 million in financing, led by Georgian Partners. The Mountain View, Calif., company plans to use the funding to continue growth, including internationally, and invest in analytics. Georgian Partners, of Toronto, invests in machine learning and applied analytics. Additional investors new to this round are the Mayo Clinic and Insulet Corp. Returning investors include Canaan Partners, Social Capital, Medtronic and Samsung Next. Expansion, commercialization with funding Glooko plans to expand its commercialization efforts in Germany, France, the U.K., Asia and the Middle East....

FDA approves first companion Dx for use with multiple NSCLC drugs

Tue, 27 Jun 2017 12:36:00 -0400

The U.S. Food and Drug Administration has approved the Oncomine Dx Target Test from Thermo Fisher Scientific Inc. It is the first test of its kind to screen tumor samples for biomarkers associated with multiple cancer therapies, in this case for non-small-cell lung cancer (NSCLC). It is expected to enable more rapid evaluation of treatment options for these patients, in days rather than over several weeks. The test was developed in collaboration with Novartis AG and Pfizer Inc.; some of the first labs to offer it will include Laboratory Corporation of America's Diagnostics and Covance...