You may have heard that Congress passed a big bill this month that impacts funding for medical research and the way drugs are approved. President Obama signed it into law today. What is it and how does it affect you?
You’re not alone if you didn’t keep track of the 21st Century Cures Act. Although it was 3 years in the making, the proposed law was overshadowed almost that entire time by the implementation of and opposition to the health reform law colloquially known as Obamacare. Moreover, the bill was significantly expanded and altered in the final weeks before passage.
In the end, it became a sprawling, almost 1,000-page bill with hundreds of provisions affected thousands of nooks and crannies of our nation’s health system, including the way the FDA evaluates and approves drugs and devices. The changes in that respect will potentially make it easier for drug companies to get drugs approved by lowering the standards for approval, at the expense of public health and safety. In essence, the law is an early Christmas present to the pharmaceutical and medical device industries.
The Cures Act actually does have good provisions. It pumps about $1 billion into addressing the nation’s opioid crisis and improving substance abuse treatment; $1.8 billion into cancer research under the banner of a “cancer moonshot” initiative; $1.5 billion into research on the brain and neurobiology; $1.4 billion into matching treatments for cancer and other diseases to people’s genetic make-up; and $500 million into the FDA, primarily to pay for added staff at better salaries.
The law also makes reforms to the nation’s mental health treatment system. These include reauthorization of suicide prevention programs, and new programs to identify kids and young adults at risk for mental illness and get them into treatment. That includes teens and young adults who may be prone to violent acts.
Tackling the Opioid Crisis
You and all Americans have much to gain from these initiatives. They have the potential to spur medical discoveries and new treatments, and enhance care delivery. That’s why they gained momentum and bipartisan support in Congress.
In particular, the opioid overuse crisis demands immediate attention, on multiple levels. It’s having a profound affect on communities across the country, and according to recent government data has triggered the first increase in the death rate among non-Hispanic white Americans aged 25 to 55 in decades.
Regular readers of MedShadow are familiar with what you need to know about opioids, a drug class that constitutes one of the largest adverse side effects among all prescriptions medications sold in the U.S.
Despite the escalating magnitude of the problem, only 10% of Americans with an opioid-use disorder currently receives any or adequate care. This is despite the fact that effective treatments exist, including therapy, counseling, in-patient detox, and the medicines methadone, buprenorphine and naloxone.
Drug and Device Approval Reforms
The far more controversial part of the law involves changes to the way drugs and devices are approved. The bottom line is this: The FDA is given new regulatory powers and flexibility to evaluate, seek public input and then authorize streamlined standards and pathways for drug and device approval. While at face value this sounds like it will benefit patients, it may do just the opposite.
The aim — long sought by industry — is to speed approvals up and get products to market faster.
For example, one change in the law would allow FDA to accept as proof of safety and effectiveness less rigorous clinical trials as well as other types of studies and data — both for the initial approval of drugs and to authorize new uses for drugs already on the market.
What could be bad about that? Well, lots, or little — depending on what FDA does with its new flexibility in coming years. Consumers will benefit if effective and safe new drugs and devices reach the market more quickly — the scenario posed by the bill’s sponsors and supporters.
Alternatively, if critics prove right, the bill could lead to some riskier, less effective drugs and devices reaching the market due to lowered standards for approval and/or a growing bias to quicker approvals. Some critics also allege that new drugs in the U.S. are already approved more quickly than in most other developed countries.
Notably, the FDA historically doesn’t move fast to change its standards and processes. So, it’s probably going to be years before the changes allowed in the new law become a reality.
Trump’s Potential Impact on the FDA
That said, the Trump administration is likely to appoint a new FDA commissioner whose allegiance and sympathy is with industry and quicker drug and device approvals. On the Trump transition website, FDA reform to this end was listed as a priority even before the new law was enacted.
Thus, the combination of the FDA’s new powers under the new law, and the new administration, could present real risks in the next four years. That warrants vigilance from consumer groups, sites like MedShadow, and the public.
At the very least, the FDA’s new powers are an experiment whose outcome is not yet certain.