Gabriel Levitt, President of Prescription Justice submitted comments to the Food and Drug Administration (FDA) in response to the Notice of Proposed Rulemaking (NPRM) titled "Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796.
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Justice founder Gabriel Levitt submitted the comments below in response to the FDA’s request for comments on its draft guidance related to “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”
Prescription Justice is proud to announce that a statement prepared by PJ President Gabriel Levitt for the U.S. House Ways and Means Committee on “Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit” is now part of the official congressional record.
Elizabeth, who is from California, periodically gets migraine headaches. To treat them, she is prescribed brand name Relpax (elitriptan), but finds that the drug is too expensive in the U.S., so she chooses to import the same drug at a much lower price. Despite federal restrictions, most medicines that are imported for personal use reach the patient. But not always. In Elizabeth’s case, instead of receiving her medication, the Food and Drug Administration (FDA) destroyed the medication after it was detained at an international mail facility (IMF). She gave Prescription Justice the green light to tell her story.
“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.