The problem with the FDA is that if often requires so much proof of safety and effectiveness that the time it takes to bring a new product to market can grow by 3, 4, or even more years. FDA delays into the time that companies have to exclusively produce and sell their products.
In recognition of this problem, the FDA sometimes grants marketing approval to innovative new devices through a Pre-Market Approval Pathway, or PMA. Under this pathway, companies are allowed to bring their products to market more quickly – with less than optimal evidence on safety and effectiveness – as long as they promise to continue collecting such data through post-market surveillance.
According to a study in JAMA, device manufacturers often fail to keep up their side of this bargain.
In the study, Vinay Rathi and colleagues looked at all 28 new high risk devices receiving PMA approval in 2010 and 2011. They found that FDA approval was often based on scant data – studies of less than 300 patients with no blinding and limited follow-up. (With blinding, clinicians measuring patient outcomes do so unaware of which patients have received which interventions. Without blinding, such outcome measures can be biased by clinicians’ expectations.)
Given the small number of patients studied prior to market approval, it is that much more important that manufacturers continue to collect data once their products come to market. Unfortunately, most devices are not well studied once on the market. According to authors of the JAMA study: “Most devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time.” In fact, almost half of post-market studies are funded without support from the manufacturer.
Why are manufacturers being so lax in conducting post-market research?
(To read the rest of this article, please visit Forbes.)
As a fan of free markets, I recognize that sometimes intelligent government regulations (not always an oxymoron!) can improve markets by requiring companies to provide consumers with information that will help them make better choices. Informed consumers, after all, are a central ingredient of a successful free market. That’s why even most libertarians support regulations that ban fraudulent advertising… (Read more and view comments at Forbes)
JoAnn Pushkin’s breast cancer was diagnosed at an advanced stage because the density of her breasts obscured the tumor on her mammograms. That was shocking news to Pushkin, who only learned that her breasts were radiologically dense at the time of her diagnosis. Activated by this revelation, she has become a leading advocate of legislation, like that recently passed in the state of New York…(Read more and view comments at Forbes)
It was 93 degrees and humid. Jimmy Lawrence put his first five quarters into the vending machine and selected a Coke. The machine refused to give him his beverage. Because the temperature was more than 90 degrees, the computer program within the vending machine had raised the price to $1.50.
Is that fair pricing? …(Read more and view comments at Forbes)
Here is a video of a webinar in which Avni Shah and I discuss some controversies about what governments should do when consumers harm themselves through irrational behavior. Avni is a doctoral student in Marketing at Fuqua. Check out the bag of sugar she pulls out to illustrate the dangers of big gulp beverages. Feel free to add questions or comments, and I’ll chime in with my additional thoughts.
New York City’s plan to prohibit the sale of large, sugary soft drinks is a brave and provocative policy, one that promotes public health at minimal cost to New York City residents.
Mayor Michael Bloomberg’s announcement last week highlights the kind of tough regulatory action we, as a society, need to make to combat an obesity epidemic that experts say will cause this generation of elementary school children to be the first in centuries to experience a shorter life span than their parents…(Read the rest here)