Written By: Priyanka Gaitonde, PHSR Graduate Student*

On Dec. 3, I and other members of the International Society of Pharmacoepidemiology (ISPE) student chapter at the School of Pharmacy – with support from our chapter advisors Julie Zito, BSPharm, PhD, professor in the Department of Pharmaceutical Health Services Research (PHSR) and Susan dosReis, BSPharm, PhD, associate professor in PHSR – organized a campus-wide debate to bring students from across the University together to deliberate the potential benefits and risks of the 21st Century Cures Act. This legislation, which was approved by the U.S. House of Representatives on July 10, focuses on enhancing development and approval processes for pharmaceuticals and medical devices.

The Pros

Tomefa Asempa, a fourth-year student pharmacist at the School; Lijo Panghat, a postdoctoral fellow at the School of Medicine; and Danielle Abraham and Jamila Torain, graduate students in the School of Medicine; argued in support of the legislation and urged the audience to understand that it will help to advance science and medicine by encouraging innovation and collaboration. They highlighted how the legislation responds to the need for treatments for serious, rare, and life-threatening conditions that tend to be under-researched and also spotlighted other positive aspects of the legislation, including increased funding for the NIH and the FDA, increased representation of traditionally underrepresented populations in clinical trials, and the incorporation of patient feedback and validated biomarkers in the drug approval process.

The Cons

On the other hand, Juan David Rueda and Bilal Khokhar, graduate students in the School’s PhD in PHSR program, along with Chuka Udeze and David Tran, second-year student pharmacists at the School, denounced the legislation and argued that further acceleration of drug approvals and approvals based only on biomarkers will weaken the assurance of benefits and result in less safe and less effective medical products. They also discussed how long-term value to the public’s health may be sacrificed to the short-term goals of faster FDA approvals for drugs and medical devices, noting that the bill increases market exclusivity for rare disease products, but does not help patients who will have to wait longer for less expensive generic versions of these medications.

Mutual Understanding

The debate was co-sponsored by the University Student Government Association (USGA) and the School’s student chapter of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR). It was attended by more than 50 students from across the University who, at the end of the evening, walked away feeling that, while this piece of legislation proposes some good policies, there are still many measures buried within it that need to be addressed and modified. In fact, it was Peter Doshi, PhD, assistant professor in PHSR, who summarized the findings best when he remarked, “The 21st Century Cures Act is a sweeping piece of legislation that will affect all of us as researchers, practitioners, and patients. However, although the University supports this legislation, few in our community know of its existence. That needs to change.  It was great to see students shine the spotlight on this bill through the debate.”

FDA "Cures" Debate (2015)

*Though submitted by Priyanka Gaitonde, this post was co-authored by Gaitonde, Tomefa Asempa, and Chuka Udeze.

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