You would be hard pressed to find a Nebraskan who disagrees when they hear that "too many patients are being priced out of the medicines they need."
And it’s guaranteed Nebraska will be reassured if they heard the Food and Drug Administration “can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.”
Nebraskans will also be reassured to know that these are the words of the newly minted commissioner of the FDA, Dr. Scott Gottlieb, a physician and cancer survivor with extensive government experience who's now serving as an extremely powerful and influential figure in the Trump administration.
In an online column published by the FDA in June, Gottlieb noted that brand pharmaceutical companies sometimes “game” the regulatory system to “delay generic drug approvals beyond the time frame the law intended, in order to reduce competition.”
The Congressional Budget Office estimates that obstruction to cost some $3.3 billion in higher government health care costs.
Exhibit A: Martin Shkreli and Turing Pharmaceuticals.
Just prior to the expiration of Turing’s patent on the anti-malarial drug Daraprim, Shkreli increased the cost of the drug a whopping 5,000 percent (!) — from $13.50 per pill to $750 per pill. And Jon Haas, director of patient access at Turing, admitted to blocking access to the brand drug for required testing by potential generic competitors.
It seems this is exactly the kind of outrageous “gaming” of the regulatory system — if not a direct contravention of, at the very least, the spirit of the law mandating the provision of sufficient quantities of a brand drug for generic testing — that Commissioner Gottlieb seeks to end.
The problem, of course, is that any policy implemented at the regulatory level of one administration can be undone by a subsequent administration. That’s why a bipartisan — and even more importantly, a biphilosophical — group of members of Congress are co-sponsoring the CREATES Act, but, so far, Nebraska Sen. Ben Sasse is not one of those co-sponsors.
CREATES stands for “Creating and Restoring Equal Access to Equivalent Samples” (S.974). The measure is before the Senate Judiciary Committee, of which Sasse is a member.
The current penalty for brand pharmaceutical companies that thumb their noses at the requirement to provide testing samples is akin to a parking ticket. And, when you consider the bonanza of additional profits to be made by slow-walking the ability of competitors to bring a generic to market, too many companies are willing to accept what amounts to a slap on the wrist if caught.
The CREATES Act puts some teeth in existing law. It provides for very narrow, but firm, civil penalties for the most egregious violations. And it’s supported by not only Republicans and Democrats, but staunch liberals such as Sen. Patrick Leahy from Vermont along with staunch conservatives such as Sen. Mike Lee from Utah.
As such, voters could understandably be excused for believing that the only reason any member of Congress could possibly be opposed to this bill is that they are deep inside Big Pharma's pocket. And that is exactly what so many Americans are talking about when they clamor for "draining the swamp."
In Nebraska alone, generic drugs saved patients $1.7 billion dollars in 2016, according to the Association for Accessible Medicines. If the CREATES Act were enacted the savings could be considerably more. For the sake of Nebraska’s patients, Sen. Sasse should and needs to co-sponsor this legislation.
That which Congress might do, only Congress can undo. The CREATES Act would take the bureaucratic politics out of this issue — for now and in the future.