By Peggy Salvatore
I liked what I had heard about the 21st Century Cures Act. It seems like a good thing, about time, getting the FDA to streamline the drug and medical device approval process. The logic behind the bill is that a lot of patient information and data are available today that can be included in decision-making to accelerate the process with access to accurate, immediate information.
This legislation combines a few of my favorite things, namely health information technology and biopharma. The gist of the bill is that it is intended to accelerate the approval of drugs and medical devices through the FDA’s regulatory process by accepting new kinds of evidence of efficacy like physician’s documentation of patient response and patient registries, two sources of data much more accessible with health information technology.
The 21CCA (I just invented this acronym) throws in funding for the National Institutes of Health which has suffered from cutbacks in recent years. The article from which I drew this information quotes NIH Director Francis S. Collins, saying, “If we hadn’t had massive cuts to N.I.H., we probably would have a vaccine for Ebola.”
So far, this bill is sounding like a good thing. What’s not to like? I’m always looking for ants at the picnic. I found a few. Where is the money going to come from for the 21CCA?
Some bold and creative individual (or lobbyists) suggested the pharmaceutical industry pay for the cost of the FDA changes and the NIH funding in exchange for adding a few extra years of exclusivity to drug patents. Right now, drug companies get about 17 years of patent exclusivity including the years a drug is in clinical trial to earn back the billions the R&D drug industry spends developing branded (original, novel) drugs. When a drug goes off patent, generic drug companies are free to copy the drugs and sell them for pennies on the dollar because they didn’t incur the cost of development; they just reverse engineer the existing drug. That’s not a bad thing on its face. But the cost of research and development (and yes, yes, marketing to let patients, doctors and health plans know about the new drug) is recouped basically in those halcyon years of patent protection. Getting a few more years of exclusivity is worth a bundle of dough which the biopharma industry could funnel back a bit to updating the FDA regulatory process and funding NIH research. Based on the outcome of that suggestion, however, somebody must have screamed “greedy drug companies”. So that idea was off the table.
The bill is now drafted so the money comes from…the oil industry. Hey, why not sell off some of our strategic oil reserves?
When healthcare turns to the energy sector to fund its forays into research, perhaps we need to re-evaluate whether we’re able to pay for the healthcare we’re getting or if some other agenda is skewing the game. Considering healthcare is coming up on 20% of the economy, you’d think it could pay for its own R&D. Apparently not.
I enthusiastically welcome comments to deepen my understanding of this issue.