Tackling drug prices

Dec. 7, 2016

Congress has passed the 21st Century Cures Act, legislation that will provide funding for the U.S. Food and Drug Administration (FDA) to accelerate the drug and medical device approval process. The legislation will also provide funding for basic, translational, and clinical research. The legislation is deemed by many as a means to quell the rising cost of drugs by encouraging more drugs to enter the market more quickly. However, additional efforts to address this issue are likely when the new Administration and Congress take over, and according to Barbara Greenan, senior director of Advocacy and Policy at the AADA, they will be multifaceted. “Certainly, expediting the backlog of generic drug approvals at the FDA is one way to drive down drug prices. However, this issue is complex and the new Congress and Administration will have to work with all stakeholders to find solutions that ensure patients have access to effective treatments.”

Specifically, several members of Congress are looking to alleviate the drug pricing issue by granting Medicare the authority to negotiate drug prices with manufacturers. “This is a concept that Democrats have largely supported and that President-elect Trump supported while on the campaign trail, but congressional Republicans generally oppose it,” said Christine O’Connor, AADA associate director of congressional policy.

Another option that has been kicked around is removing restrictions on drug importation. For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) introduced the Safe and Affordable Drugs from Canada Act. “President-elect Trump has indicated that he would support re-importation of drugs,” O’Connor said, “and there is some bipartisan support in Congress to do this. However, the pharmaceutical industry opposes re-importation.” Similarly, Congress may also turn the focus on the manufacturers and require more transparency into drug-pricing methods. “For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Tammy Baldwin (D-Wis.) introduced the FAIR Drug Pricing Act that would require drug manufacturers to explain price increases of more than 10 percent.” While these pieces of legislation will die at the close of the 114th Congress, similar legislation may be introduced next year in the new 115th Congress.

Of course, even if legislation passes muster in both chambers on the Hill and in the White House, the new Administration will likely be tasked with implementing these new laws. “There will be a heavy lift on the regulatory side to implement and operationalize drug pricing legislation,” Greenan said. “However, rising cost of drugs cannot be ignored and the AADA looks forward to working with the new Administration and Congress on addressing this highly impactful issue in the context of other health system reforms.”