By Paul Gionfriddo
July 25, 2017 at 5:00 am ET
To address our nation’s mental health challenges, we need to see a tremendous degree of focus in Congress over the next few weeks.
Current investments are needed in mental health services, treatments, and supports — while making the new ones promised in the 21st Century Cures Act to improve services to children and adults before Stage Four crises occur. We cannot leave people with mental illnesses behind as we seek to control Medicaid spending, any more than we can take back the promise of parity by reducing access to insurance coverage for people with chronic mental illnesses.
But that’s not all.
Although it’s often lost amidst the intense coverage of how Congress might repeal and replace Obamacare, we’re also coming up against another important health policy deadline that affects the lives of millions.
The Prescription Drug User Fee Act — now 25 years old — will expire in September. From the beginning, this law has had broad-based support among policymakers, the industry, and stakeholder groups representing consumers and providers. And, why not? With this law in place, the average review time for a new pharmaceutical product has dropped from two and half years to 11 months. This means modern, often life-saving drugs are getting to the people who need them more than eighteen months faster.
PDUFA supplements the resources of the Food and Drug Administration with user fees paid by pharmaceutical companies — a win for taxpayers. The FDA uses these fees to enhance staffing and get reviews done more quickly. The user fees do not give industry any control over the FDA — they just help the FDA do its job.
That’s why we need the U.S. Senate to focus on PDUFA before the September deadline hits. The House has already passed a new five-year reauthorization bill, and their colleagues on the other side of the Capitol need to follow suit.
It won’t be easy. In addition to the constant turmoil over health reform, there will no doubt be efforts to use the PDUFA bill as a vehicle to address other unrelated issues. Tying up PDUFA runs the risk of hurting some of our nation’s most vulnerable citizens. We need this law simply so that there are fewer delays between new medical innovations and the patients who need them to thrive and survive.
Over the past several years, we have seen promising new developments in biopharmaceutical research on how to treat mental disorders better. We can foresee treatments that will offer the promise of more productive, fulfilling lives and futures to millions of Americans who live with the experience of serious mental illnesses.
We call this “recovery,” and it should be our minimum level of expectation for every chronic disease. The problem is that there are currently over 200 staffing vacancies at the FDA and the agency needs hundreds more qualified professionals to reduce drug approval backlogs and modernize clinical trial processes.
In an age in which there is so much need for new treatments and therapies, and in which science is responding with exciting breakthroughs generated by expanding knowledge about brain chemistry and genomic research, we need the FDA to be equipped to move innovations from clinical trial to hospitals, pharmacies, and physicians’ offices.
This isn’t the time for the suffocating political problems of the present to turn back the clock, while diverting our attention from the future of health and mental health care.
We need our senators to stay focused on our health over the next few week so millions of their fellow citizens will be able to lead more independent and productive lives.
Paul Gionfriddo is president and CEO of Mental Health America.
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