Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if the Secretary of the Department of Health and Human Services (HHS) certifies that importation would “pose no additional risk” to U.S. consumers and “result in a significant reduction in the cost” of those prescription drugs. Over the past 16 years, no Secretary of HHS has been willing to make that certification. As a result, Section 804 has remained dormant. In the wake of President Trump’s election, many consumer advocacy groups have been urging his administration to activate Section 804, but HHS Secretary Alex Azar dismissed the idea as a “gimmick.” Now, it appears that Secretary Azar has reconsidered the issue.
On July 31, 2019, HHS released its “Safe Importation Action Plan,” which is designed to pave the way for the importation of select prescription drugs from foreign countries. The plan would provide two pathways to facilitate drug importation: (1) a pathway that would allow “demonstration projects” under Section 804, where States, wholesalers, or pharmacists could import Health Canada-approved drugs into the United States; and (2) a pathway that would allow manufacturers to import “versions of FDA-approved drug products that they sell in foreign countries” under a new National Drug Code (NDC) for those products, “potentially allowing them to offer a lower price than what their current distribution contracts require.”
This announcement marks a major shift in U.S. policy regarding prescription drug importation, and it will have a significant impact on regulated industry. This webinar will:
- Frame HHS’ announcement in the context of the policy debate about providing access to cheaper prescription drugs by importing drugs from other countries, such as Canada.
- Outline the new policies announced by HHS, including the two proposed pathways for prescription drug importation.
- Address the myriad questions presented by the newly announced policies, including, among other things, HHS’ legal authority under Section 804, drugs that are eligible for importation, the HHS Secretary’s certification of “no additional risk” and “significant cost reduction,” the role of States in sponsoring demonstration projects, the impact on the global drug supply chain, and HHS’ all-or-nothing approach to severability.
- Provide our thoughts about the broader implications of the policy shift, including the additional pressure on drug manufacturers to reduce drug prices.
Thursday, September 12, 2019
1:00 P.M. – 2:00 P.M. ET
If you have questions concerning this roundtable webinar, email firstname.lastname@example.org.
King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, email@example.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.