Do you know that nightmare where you see someone about to get hurt or worse, but they don’t see the obvious danger? And your anguished pleas go unheard?
You wake from this frustrating helplessness, relieved it was just a dream.
Except, right now, I’m not waking up.
The United States appears to be rushing headfirst to surrender our global advantage in medical discovery and choosing to let people suffer and die denied a breakthrough cure. To worsen the nightmare, the normal democratic process of public discussion that an open society relies on to keep bad ideas from becoming bad policies has been abandoned.
A mislabeled climate and spending bill included a policy that reversed 40 years of bipartisan healthcare agreement. It was enacted with limited public debate, without a single vote from the opposition party, and in a fast-tracked process designed to undermine democratic discourse and ensure its passage.
Signed by President Biden as the “Inflation Reduction Act,” this law sets in motion the radical undoing of how we discover new treatments and get patients access to cures. Normally, as agencies begin to enforce a law Congress has passed, it would go through a “public rulemaking” process requiring public notices, extensive opportunity for the public to comment, and honest engagement with stakeholders to obtain input to improve implementation.
Not this time.
The process and the policy are an affront to 250 years of self-government. What this new law could do to global health and the value our nation places on the health, safety and prosperity unleashed by innovation is the nightmare we need to wake up and end.
I recently submitted a formal public comment on the Centers for Medicare and Medicaid Services’ implementation guidance for the IRA’s plan for price controls. CMS has constrained the public to one limited chance to weigh in on this radical departure from a four-decade consensus. A consensus was forged in the 1980s between a liberal Democrat and a conservative Republican. Passed by both parties, the Hatch-Waxman Act led to the creation of an ecosystem of scientific discovery that saved millions of lives, including mine. Not to mention jumpstarting the delivery of cost-efficient and effective generic medicines that today are 90 percent of all prescriptions.
Oh, and you had only 30 days. Even the Federal Register says that agencies can issue comment periods of 60 to 180 days for “complex rulemaking.” Apparently, CMS doesn’t consider its Drug Price Negotiation Program consequential enough, despite the effect it will have on individual patients and humanity itself.
This isn’t some academic experiment, to me, at least. As a patient with multiple sclerosis, I am one of the millions who could lose a chance at accessing a cure with the implementation of Medicare drug price controls. With government regulators focusing on costs over cures, scientific discovery will be affected. Who will risk their reputation, brainpower, or capital chasing a breakthrough that will never recover its investment?
Drug price controls have a terrible downstream effect that the government refuses to consider or acknowledge. When a company seeking to cure diseases like cancer or Alzheimer’s is forced by the government to sell their medicines beyond rates that reflect the time and effort poured into them, it will effectively empty all resources needed to continue to innovate. It’s an unfortunate reality, and it’s a reality CMS and the federal government are refusing to consider.
While no one can predict what will happen when Washington meddles with the delicate balance of risk, research and discovery, I know that it will take much longer than 30 days to list all the damage such a government incursion would produce.
A decades-long bipartisan consensus held that the government should be kept from controlling prices that are best set between providers and beneficiaries.
The same government that has less trust than used-car salesmen and has trouble with counting blimps in our sky is now telling us it can master the economics and intricacies of delivering breakthrough medicines and needs only 30 days of public input before it risks the world’s most extensive incubator of hope. I’m not buying it, and neither should you.
We need to wake up from this nightmare.
