We're in the midst of the biggest overhaul to the prescription-drug market in a generation. But is that good news or bad?
Under last year's Inflation Reduction Act (IRA), the government is rolling out a complicated system of price controls. In theory, this is supposed to make medicines more accessible to patients. But in practice, it is certain to stifle innovation. Studies from the University of Chicago, the University of Southern California, and the Congressional Budget Office have all found that the bill's price caps will limit reinvestment in drug research, in turn reducing the number of future cures that come to market. This will do immeasurable harm to patients in the long run.
But now that the administration is moving forward with its dubious scheme, the least it can do is implement it in a fair and transparent manner. Unfortunately, that's not happening. As insurers, hospitals, pharmacies, and other health-industry players lobby the government for advantage, the very people the new system is supposed to help -- patients -- aren't being heard.
To be sure, CMS has paid lip service to the idea of patient input. This month, it held a series of listening sessions on the IRA, inviting testimony from people who take any of the 10 drugs that will be subject to the first price controls. But patient comments were limited to a mere three minutes each. That seems an impossibly short time in which to tell a meaningful story.
Meanwhile, the process of signing up to speak wasn't smooth. It required people to enter an email address before they could access important information about the sessions, and made caregivers obtain a power of attorney before they could share information about loved ones, according to Michael Ward of the Alliance for Aging Research, a patient advocacy group.
Speaking at an October conference, Ward also noted that during an earlier period in which CMS invited written responses from patients, it asked them for data and technical answers to which they wouldn't necessarily have access.
Even as patients struggle to make their voices heard, some groups claiming to speak for patients may not be what they seem. For example, Public Citizen -- the far left political advocacy organization – is pressuring the government to implement the IRA without any regard for how this might affect patients waiting for still-undiscovered treatments.
The public also lacks information on who is in charge of the price-setting program at CMS. Last year, the agency appointed Kristi Martin as senior advisor in charge of staffing up the team. Yet Martin was previously a principal at Waxman Strategies, a firm that lobbies on behalf of hospital groups. She also led health policy at Arnold Ventures, an advocacy group with a long history of trying to capsize our current system of drug development, despite the impact this could have on innovation. The opportunities for conflict of interest are significant. When is a conflict of interest not a conflict of interest? When it's in the interest of Uncle Sam, MD.
In short, the government is throwing up barriers to patients who want to have a say in the drug price-setting process -- and the Biden administration has tasked people with dubious motives to run the program. Patients shouldn't have to fear that CMS isn't prioritizing their interests.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
