To the best of your knowledge, would it be illegal (notwithstanding any copyright claims) to produce an interface that would make FDA compliance easier?
Examples:
- a website that republishes FDA information in a far easier to grok manner (assuming they are as impenetrable as most government websites I've had the misfortune to require using)
- a choose-your-own-adventure formatted application made in Twine that would allow you to explicitly follow the known rules
- an application that alerts drug/device developers of guidance updates
Good question. Broadly speaking, the whole regulatory space (not just FDA, but all other agencies) is indeed a massive business opportunity. There are basically two ways to operate here:
Option 1: reduce costs of complying with FDA.
Option 2: reduce the power of FDA.
Option 1 means automation of form submissions, NLP/data mining on past enforcement actions, search engines for FDA.gov like FDAZilla, reproducible research templates for regulatory filings, that kind of thing. That helps, but only up to a point, as the FDA themselves is not very tech savvy and will look askance at any attempt to significantly streamline the process. From their perspective: streamlining means regulators will do more work in a shorter amount of time for no increase in pay, which they don't want to do, and which may well be perceived by them as aggressive behavior on your part (moving too fast). They think in terms of years to clearance, not days or weeks.
So then there is Option 2: reduce FDA power. I've come to believe that the second strategy is much more effective in the long run. So what does that entail?
1) Regulator review sites. Something that might be
surprisingly effective would be a site that named and
shamed individual regulators, kind of like TheFunded.com
for regulators. With some good SEO this might be the single
most effective thing one can do. It would be incredibly
popular and could branch out into SEC, EPA, and other
agencies.
2) Regulatory review sites. Relatedly, with all other
domains (movies, music, books, etc.) there is a thriving
system of competitive, third party reviews and star
ratings. Yelp, Amazon, Metacritic, Rotten Tomatoes, even
Google PageRank are all review methodologies that are
intentionally robust to the decisions of a single
regulator. Figure out how to get 2000 cardiologists
worldwide to do public internet reviews of heart
drug/devices rather than a hand-picked FDA panel of 15, and
you can show under very conservative assumptions that the
resulting rank-ordering of products will be far more
accurate.
3) Filing in other countries first. For example, within medical device companies, it's well known now that you get your CE Mark in Europe first[1,2,3], and then think about the US. You can get some revenue and the CE Mark process is far more consistent than the US.
4) Otherwise enhancing regulatory competition. Imagine if Harvard, the Mayo Clinic, and Cedars-Sinai could suddenly clear drugs and devices like the FDA. The FDA already contracts with scientists from there to run their expert panels, as they don't have the expertise in house. The CE Mark strategy above is this in embryo, but it's only two jurisdictions (EU and US). I'm not sure how you'd pull this off, but the basic idea is to use other "name brands" in medicine to help set up regulatory competition.
5) Software-based regulatory arbitrage. With modern information technology, it may be possible to locate software-based components of a device/drug overseas in fast market access countries[4] like Singapore, Hong Kong, or Israel.
6) Medical tourism and/or medical cruise ships. Figuring out ways to do internet marketing of offshore medical tourism to Americans, with transparent prices and treatments proven in other countries (even if not FDA approved) will be a big deal over the next 10-20 years as the US medical system enters crisis from all the aging seniors. All you need is a relatively small but high profile group of people voting with their dollars to seek treatment or move operations overseas to start provoking real change. Nothing within the system will do that now.
These are the sorts of ideas, many informational, that I think will have a much bigger impact than methods to streamline compliance.
Right, but if there were a private system similar to the one in which Underwriters Laboratories operates, that'd be preferable. I'm not sure how to get there from here, which is why I said "I'm not sure how you'd pull this off".
For example, it might be feasible to get Cedars-Sinai to partner with (say) Singapore's HSA and do some kind of fast track approval process intended to compete with FDA's slow approval. Here Singapore's name brand would be enough for the Asian market while Cedars' brand would establish to American medical tourists that the product/device/service had been vetted.
Examples: - a website that republishes FDA information in a far easier to grok manner (assuming they are as impenetrable as most government websites I've had the misfortune to require using) - a choose-your-own-adventure formatted application made in Twine that would allow you to explicitly follow the known rules - an application that alerts drug/device developers of guidance updates