An open letter to the next FDA Commissioner

Neil Thanedar
Feb 7, 2017 · 4 min read

The FDA spent $4.7B last year. Where did it go? Did it make us safer? All of this work will have been in vain if the results are not accessible to the public. That’s why it is alarming to see the Trump administration freeze USDA and EPA releases, further limiting the public’s access to important scientific and medical data. We’re headed in the wrong direction.

Strict pre-market regulations on pharmaceuticals and medical devices are limiting public access to generic medications and blocking new health technologies from being openly tested. On the other hand, recent FDA commissioners have taken a reactive regulatory approach to industries like food, supplements, and cosmetics, enforcing recalls only after products make people sick. The FDA’s data is inaccessible to the average citizen and the results of most clinical trials and analytical testing are similarly siloed. The result is a regulatory system that’s both closed and inefficient.

Mission: An open, efficient market.

We need a FDA commissioner that promotes transparency, progressive regulation, and more post-market testing.

1. We need more transparency. Every administration must increase transparency into each department. Fill Data.gov with reports and datasets and promote USDS to make this information accessible and user friendly. The last administration made these programs a priority, and we need to build on this work. The FDA commissioner must also push for transparency in the private market and enforce existing laws that are clearly being broken. Kill the “pay-to-delay” deals that let pharmaceutical companies monopolize markets and increase drug prices.

2. We need progressive regulation. Life is already tough for small businesses. Without resources or connections, they battle to gain traction. In FDA-regulated industries, this struggle comes with the added burden of complying with regulations that are often confusing, contradictory, and haphazardly enforced. Meanwhile, large corporations have regulatory and compliance departments specifically tasked to complete mounds of paperwork. Bureaucracy becomes a competitive advantage for companies willing and able to play this regressive system. The next head of the FDA must push for progressive approval of new innovations, with fewer steps to market and more independent testing. Simultaneously, the FDA needs to increase market surveillance to quickly identify failures in the market. The burden of proof for these companies ought to increase as they scale.

3. We need more data. Specifically, we need more accurate data. The last 20+ years have taught us to believe that the internet can answer any question. Ask millions of people to rate the best restaurants, and you’ll get a (reasonably) accurate set of rankings. Repeat this model for all books, movies, etc., and we quickly get a Google’s worth of information. This kind of crowdsourcing doesn’t work with health data. Ethically, we need to verify a product’s safety before we give it to millions of people. Also, we need experts, armed with study controls and diagnostic tools, to assess a product’s efficacy. Clinical trials and analytical testing remain the gold standard for collecting this data, but most of this research is industry-sponsored, ceding control in ways that can mislead the public. We need an FDA commissioner that will doggedly push to increase independent public and private funding of new trials.

Most importantly, we need clear leadership in both the public and private sectors to build these reforms.

Free markets don’t magically regulate themselves; we have to build the right checks and balances into the system.

A path forward.

At Labdoor, we’ve spent the last five years performing testing and educating consumers about vitamins and supplements. We saw an open market with thousands of products but very little accurate information, and set out to make it more efficient. Labdoor’s platform has two key characteristics:

  1. Open, verified market. Any product can join Labdoor’s market. We pay to test each product before listing it for sale.
  2. Sustainable, consumer-driven business model: All Labdoor data is available to consumers for free. If someone buys a product through our market, we earn a commission from the sale, which funds our operations.

Labdoor will test its 1,000th supplement this year. We’re also opening a new analytical lab capable of testing a wide range of home, health, and beauty products. We work every day on a basic cycle of more testing, which drives more data, which drives more sales, which drives more testing. Our system gets better as it gets bigger. We also know we have a long way to go, and are motivated by the huge amount of products left to test. Imagine buying all food, cosmetics, and medications in this way.

The public deserves a clear, quantitative understanding of each market, and we’re excited to contribute to this mission with the FDA. There’s a lifetime’s worth of science needed to build the open, efficient market we all deserve.

Ready to work,

Neil Thanedar, Labdoor’s CEO and Founder

Labdoor

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