Initiatives like DukeEngage have funded students to learn first-hand how issues of global health affect those in developing countries. But sometimes, you don’t have to go anywhere to profoundly influence global health.
Biologic drug affordability is one aspect of reform that has received little attention. Biologics are different from conventional drugs in that they are derived from living cells. These include drugs like Humira for treatment of Crohn’s disease, priced at $4,000 per month, and Herceptin, used to treat breast cancer, which can cost $37,000. Unlike conventional drugs, there is currently no FDA approval process to enable cheaper generic biologics to come to market, meaning that prices are likely to stay high indefinitely.
Generic biologics could provide an estimated $71 billion in savings over the next 10 years. Unfortunately, current provisions to approve generic biologics sponsored by N.C. Sen. Kay Hagan and Rep. David Price have some major flaws, including 12 years of additional market protection (conventional drugs get five years despite comparable research and development costs) apart from 20-year patents. This 12-year protection, coupled with provisions that allow companies to make minor changes to the drug and receive additional 12-year periods of protection, effectively creates a “no generics” proposal.
Student groups at Duke and the University of North Carolina have cast aside our rivalry to work side-by-side, as we are concerned that the proposed “no generics” provisions stand between patients and affordable access to tomorrow’s breakthrough medicines. As part of the AffordableMedsNow.org campaign, we call for no more than the five years of exclusivity, which is the protection given to conventional drugs.
Thanks largely to generic competition, the cost of first-line AIDS therapy in developing countries dropped from $10,000 per year to less than $100 per year. Today, you have the opportunity to improve the health of millions. We ask the Duke community to contact your Congressional representatives, and stand with UNC in support of patients’ right to affordable generic biologic drugs now.
Chris Manz
Second-year student, School of Medicine
American Medical Student Association
David Watkins
Fourth-year student, School of Medicine
Universities Allied for Essential Medicines