A recent Wall Street Journal piece regarding why pharma is having problems producing effective product caught our eye. The Feb. 9 op-ed article, called “Health-Care Investment: The Hidden Crisis” [subscription-only access] lays out ways that Washington “can remove some of the barriers to growth in medical research.” Its author: Michael Milken.
He argues that “improved public health translates directly into greater national productivity, which underpins all economic growth.” He cites figures showing how life-expectancy gains have added to America’s prosperity, and expresses concern that cuts in NIH funding “will cause some younger medical scientists to either change careers or take their work to places like Singapore” which welcome researchers.
The barriers he talks about are the usual suspects: anticipated patent expirations, regulatory issues, qualms about litigation exposure, and high U.S. taxes on repatriated overseas earnings.
Mr. Milken is on point linking ROI and extended lifespan. The study he cites –- that gains in life-expectancy since 1970 have added $3.2 trillion per year to "America's national wealth" – is impressive. We further argue that if more attention were paid to medication adherence, then that figure would be even more impressive.
Mr. Milken also argues that the FDA needs more resources to “keep up with the pace of innovation in such areas as medical-device development and regenerative medicine.” Agreed – let alone with inspecting clinical trials on foreign soil.
But let’s also consider this: The FDA needs resources to find different ways to solve their medical information problems. While the FDA guards public health, the FDA doesn’t produce good guidance on medical information and as a result industry may not provide good medical information to the patients using its products. A few years ago, the public didn’t have access to this information, but now it does. And the public will be talking about this information on social media sites. We believe the FDA isn’t moving quickly enough on its social site regulations or being adaptive enough about the content it regulates. It needs the time and resources to define flexible policies, not to apply additional funds to enforcement.
To our way of thinking, the FDA should become less regulator, and more healthcare-outcome policy initiator and promoter.