Prescription Justice founder Gabriel Levitt submitted the comments below in response to the FDA’s request for comments on its draft guidance related to “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”
Founder of Prescription Justice, Gabriel Levitt, submitted a public comment to the World Health Organization (WHO) on the role of personal importation and online access to safe and affordable medicine in meeting the UN Sustainable Development Goals. The Global Action Plan for Healthy Lives and Well-Being for All is a joint initiative led by twelve global health and development organizations under the auspices of the WHO.
“Pursuant to the evidence and reasons given above, I believe my testimony overcomes the FDA’s public health justifications for refusing my medication order and ask that you release it to me. If you don’t then my health may be jeopardized because I can’t afford it locally.” Letter from a patient to the U.S. Food and Drug Administration (FDA) whose arthritis medicine was detained, and subject to refusal by the FDA. Each year, a few million Americans import lower cost medicines because the prices are lower, despite the federal restrictions. Most such orders are received, at least when patients have valid prescriptions, but the FDA has the authority to refuse and destroy them.
A group of over 50 healthcare providers, including physicians, nurses and physician assistants, have come together to demand the federal government stop any action that would restrict access to lifesaving medications through personal prescription importation. In a letter sent to President Donald Trump, members of Congress and the Food and Drug Administration (FDA), the healthcare providers expressed their alarm over FDA’s action in Florida against offices that primarily serve older Americans who prefer in-person assistance with purchasing medications from Canada and other countries, rather than using an internet site.
Prescription Justice recently joined with nine other health, social justice and consumer advocacy organizations to launch a petition to demand Congress act to bring relief to the millions of Americans who can't afford the prescription drugs they need. The online petition largely echoes the Prescription Justice policy platform which prioritizes ending the ban on Medicare negotiating drug prices, making pay-for-delay deals illegal, and permitting wider access to lower-cost, imported medication through legislative, regulatory, and policy reforms.