The House Committee on Energy and Commerce’s Health Subcommittee held a hearing today titled “21st Century Cures: Examining the Role of Incentives in Advancing Treatments and Cures for Patients.”
A bill introduced in September 2013, the “Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act of 2013” (H.R. 3116) featured prominently as legislation that could improve incentives for pharmaceutical and biotechnology firms to invest in research and development (R&D) of products that tackle unmet medical needs. Mental illness represents a vast unmet medical need, and AFSP supports incentives that allow promising new therapies to reach the market.
Witnesses included Marc Boutin, the Executive Vice President and Chief Operating Officer of the National Health Council, Kenneth Davis, president and CEO of the Sinai Health System, Alexis Borisy, a partner at Third Rock Ventures, Mike Carusi, general partner at Advanced Technology Ventures, Fred Ledley, professor and Director of Natural and Applied Sciences Management at the Center for Integration of Science and Industry at Bentley University, Steven Miller, the Senior Vice President and Chief Medical Officer of Express Scripts Holding Company, and C. Scott Hemphill, a professor of law at Columbia Law School.
Mr. Boutin urged the subcommittee members to support the MODDERN Cures Act. “There are more than 133 million people living with one or more chronic conditions – that’s more than 40% of the population. Effective treatments are available for some. But for many patients, all they have is hope,” he stated. Mr. Boutin also commented, “Some of the best science is not translated into treatments – simply because they don’t meet the technical requirements for a patent. From a patient perspective, this makes no sense, and Congress can fix it.” He concluded by declaring “it’s time to update our innovation ecosystem.” Dr. Hemphill argued that the regulatory protection granted under the Act, which is several years longer than most existing drug protections, could “grant a windfall for a large number of drugs that would have been developed anyway,” due to the Act’s broad definition of “unmet medical need.” His testimony advised a narrower scope for proposed incentives.
Committee Chairman Fred Upton (R-MI) delivered an opening statement questioning “whether current regulatory and economic incentives are sufficient to encourage robust investment into research and development of innovative new drugs and medical technologies.” Both he and Subcommittee Chairman Joseph Pitts (R-KY) highlighted that the vast majority of known diseases affecting patients lack effective treatments. Rep. Pitts also commented, “we cannot lose sight of the fact that new products targeting diseases that impact large patient populations such as diabetes and Alzheimer’s take much longer to get to market and are therefore becoming less attractive for investors and companies to pursue…if and when they ultimately get to market, these products are often left with the least amount of patent life and are granted the shortest exclusivity periods.”
In response, Rep. Henry Waxman (D-CA) cautioned, “We cannot legislate scientific advances. In some areas, the lack of new treatments is attributable to a lack of scientific knowledge, not the lack of incentives. To tackle these problems, we will need more investment in research.” For many psychiatric conditions, including major depression, bipolar disorder, and schizophrenia, the dry drug pipeline is likely due to such a knowledge gap. With the exception of bupropion hydrobromide, all anti-depressants approved by the FDA over the last 15 years have been compounds that focus on the neurotransmitter serotonin. The precise neurochemical underpinnings of many mental illnesses are still poorly understood, and continued support of basic science research is essential to spur future innovation.
There is a pressing need for novel psychiatric medications to treat depression, bipolar disorder, schizophrenia, post-traumatic stress disorder and other mental illnesses correlated with an increased risk for suicide. In addition to higher efficacy, drug characteristics such as faster action and fewer or less severe side effects could significantly reduce the burden of these chronic, disabling conditions. Anti-depressants currently on the market usually take four to six weeks to show treatment response, and the risk of suicide increases during the time between starting medication and symptom remission. In order to save the lives of those suffering with mental illness, strong investment in funding for research, as well as a favorable regulatory environment for pharmaceutical development are both necessary.
Please click here to read the witness testimony of Dr. Fred Ledley, Professor, Natural & Applied Sciences and Management Director of the Center for Integration of Science and Industry at Bentley University