It’s been a tough year for the United States Congress and healthcare legislation – you might have heard, they failed to repeal and replace the Affordable Care Act nor have they made much leeway in fixing its problems.
So, when a headline like “US senate unanimously passes health care legislation” pops up, it’s really worth looking at! And that’s exactly what happened.
The United States Senate approved the right-to-try bill by unanimous consent last month, which allows critically ill patients to request access to experimental medicines without Food and Drug Administration (FDA) approval.
What the bill does is allow seriously ill patients to request access to experimental drugs after all other available treatment options have been exhausted without the FDA’s two cents. These experimental drugs have successfully completed Phase I clinical trial testing.
The process ordinarily requires both the drug manufacturer and the FDA to approve the patient’s request – but the bill would drop the need for the FDA to approve, theoretically making the process easier.
All you government/politics junkies already know that the bill still needs to pass the US House of Representatives before the president can officially sign it into law.
However, to call this a success or even progress might be overstating it.
First of all, the FDA routinely approves these patient requests almost 100% of the time – so the bill cutting the FDA out of the process doesn’t do anything; it solves a problem that didn’t exist. It’s like selling dragon repellent – great to have, if dragons were actually a thing.
Secondly, the bill fails to address the biggest obstacle facing people who seek these experimental drugs: Pharmaceutical companies have complete discretion over whether to grant or deny such requests.
And they deny a lot.
So the bill doesn’t prescribe a solution for the real problem – how to get drug companies to approve the patients’ requests for these potentially life-saving drugs. What makes matter worse is that these drug manufacturers don’t really provide reasons or standards for their approvals or denials. Patients are blindly at the will of these companies who often seem to arbitrarily make these decisions.
One solid reason why they deny these patients’ requests so often is because should a patient get harmed while taking these experimental treatments, the FDA might have grounds to deny approval. Therefore these drug companies aren’t willing to take that risk.
Therefore, the Senate’s bill should have included ways to mitigate or even reward these risks. But alas, the bill is devoid of any.
One could argue that any day health care-related legislation is discussed – let alone passed! – is a good one, because at least the conversation is being had. But we must be careful to call it a full-blown success, when the fear is that no real progress will be made.
So call your local House Representative and let your voice be heard on the matter before the House votes!
