What's Hot and What's Not in Mobile Apps Regulation

A recent AusBiotech session on mobile medical apps raised some hot issues on regulation of these "medical devices"

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FDA Releases Draft Guidance on Mobile Apps

US FDA announces publication of draft guidance on Mobile Medical Applications. FDA signals a “narrowly-tailored approach” focussing on a subset of apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device but the scope is still broad and includes anything that meets the definition of a device under the FD&C Act.

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Has the US Supreme Court opened the door to off label promotion?

In a judgement Thursday [IMS v Sorrell]  the US Supreme Court ruled that information provided by manufacturers about possible off label uses of medicines is subject to First Amendment protections of free speech.  

The implications for what's can be said in direct to physician promotion of drugs and medical devices may well be profound.

This case was actually about a (successful) challenge on a Vermont State law restricting access to drug prescribing information.  However as an aside - the judgement got into issues of free speech.

The relevant passage is on page 22 of the judgement. 

But the “fear that people would make bad decisions if given truthful information”  cannot justify content-based burdens on speech.  Thompson, 535 U. S., at 374; see also Virginia Bd. of Pharmacy v.  Virginia  Citizens Consumer Council,  Inc., 425 U. S. 748, 769–770 (1976).   “The First  Amendment directs us to be especially  skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”  44 Liquormart, supra, at 503 (opinion of Stevens, J.); see also Linmark Associates, Inc. v.  Willingboro, 431 U. S. 85, 97 (1977). These precepts apply with  full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced” consumers.  Edenfield, 507 U. S., at 775.

The very clear reference to the sophisticated audience of physicians will mean there some urgent rethinking to be done as to the restrictions on advertising and promotion in the US of FDA regulated products.  

Direct to Consumer Genetic Testing – When is Home Use appropriate?

FDA’s Molecular and Clinical Genetics Advisory Panel met on 8-9 March to debate Home Use or Direct to Consumer (DTC) Genetic Tests and provided guidance on conditions under which kits may be suitable for home use.

FDA’s advisory panel considered 3 questions posed by the Agency:

• The risks and benefits of supply of direct to consumer genetic tests;

• Risks associated with  misunderstood or miscommunicated results from home use tests and possible mitigations; and

• The level and type of scientific evidence that should be required for home use genetic tests and specifically if this should be any different to that required for prescription testing.

It was a lengthy debate over two days and a complex set of issues were discussed and of course there was not always agreement.     But there were some interesting  views expressed…

Some (but not all) tests  should be prescription only

The panel considered the suitability for home use of five specific types of test: carrier tests, pre-symptomatic tests, susceptibility/pre-dispositional tests (risk assessment), pharmacogenetic tests, and nutrigenetic tests.  Supply of home use genetic tests was certainly not ruled out – but there was an abundance of caution (and caveats) and consensus that at least some tests should be prescription only including  pre-symptomatic tests with high predictor for a disease, with potentially severe consequences, and pharmacogenetic tests.  At the other end of the scale the panel was comfortable with the possibility of at least some types of nutrigenetic tests being offered direct to consumer. 

One suitable safeguard is to require results for certain home use tests to be provided via a clinician.  That’s an approach which has found acceptance in a number of other jurisdictions.  For example tests for certain STDs – where the availability of a home use test may provide public health benefits through increased use.  There are a number of non genetic test examples of such DTC kits with clinical routing of results – for example HPV testing.

Patient knowledge tests?  Kit suppliers required to provide counselling?

In considering the risks from misunderstood or miscommunicated tests, the panel pointed to the challenges arising from the absence of established  performance characteristics for some population/test combinations and the differences in absolute risk between geographic and ethnic groups.  Clear labelling is obviously important but the panel also floated the idea of requiring a qualifying “knowledge test” to assess if a patient was able to understand the result, prior to supplying the test.  The panel also expressed the view that suppliers should be required to provide access to qualified genetic counsellors for their customers.

Multiplex tests “valid and appropriate” approach

Selection and validation of a subset of  genes was considered analytically valid  although the panel cautioned that this approach would require confirmatory testing of the results of highly multiplexed clinical tests.

No Harmonisation here

IVD regulation continues to evolve globally and home use genetic testing will continue to be a sensitive issue.  There  are no shortage of new tests, many supplied via Internet marketing channels without regulatory approval.   FDA has cracked down on some of these.   In some jurisdictions, including Australia, home use genetic tests are banned completely.  In Europe, all home use tests must pass detailed design dossier review by Notified body before they may be sold.   In others (e.g. Korea) there are proscribed lists of specific tests which may not be supplied direct to consumers.    

Global Harmonisation has yet to come for IVDs.  This regulatory complexity, coupled with the breathtaking pace of innovation in diagnostics which means regulators are often forced to play catch up, means that it’s a daunting ask to bring new IVDs to global markets.

Click here for the summary of the Panel meeting 

Arthur Brandwood 

Developing a new IVD?  Entering a new International market?  Brandwood Biomedical has extensive experience in regulatory requirements and submissions for IVDs including in emerging markets in the Asia Pacific.  Contact us for a confidential and obligation free discussion of your needs.

510(k) or PMA?

Nanosonics innovative Trophon EPR achieves US market entry with a 510(k)

Nanosonics Trophon EPRAdvances in technology fall into two camps; Evolutionary development or Disruptive game changers. Safe, non-toxic and fast disinfection of ultrasound probes was gaining gradual improvement until the development of Nanosonics Trophon EPR. Here was the disruptive solution the market needed; the superb performance is like nothing else!

Everyone knows you can’t have your cake and eat it, too. Wouldn’t a disruptive solution need a costly PMA to be sold in the US? This was the challenge faced by our client Nanosonics.  With thoughtful approaches to meet US regulatory demands and extensive communication with the FDA, Brandwood Biomedical is delighted that a carefully created submission has resulted in a 510(k) issued on the basis that the stated use has substantial equivalence to predicates.

Brandwood Biomedical congratulates all the team at Nanosonics on achievement of access to the US market, and looks forward to news of American customer delight and commercial success for the company.

By the way, if you want to read an interesting book on how the best companies achieve great outcomes in seemingly contradictory or counterintuitive circumstances, have a look at “Doing Both: How Cisco Captures Today's Profit and Drives Tomorrow's Growth” by Inder Sidhu.