Last month, I blogged about the FDA Office of Criminal Investigations’ sending agents with search warrants to pharmacy storefronts in Florida that help older people buy more affordable medications from Canada and other countries. The FDA tried unsuccessfully to get one of the stores’ owners, Bill Hepscher, who runs Canadian MedStore, to sign a statement acknowledging that reimportation of prescription drugs is illegal. The Florida pharmacy storefront story was first reported in Kaiser Health News.
Yesterday, Senator Bill Nelson (D-FL) sent a letter to FDA Commissioner Scott Gottlieb demanding to know why some prescription orders coming from Canada and other countries were seized, and inquiring why the FDA raided the storefront offices.
Clearly, Sen. Nelson understands the technical illegality of personal drug imports and the need to protect people from counterfeit drugs and Fentanyl. However, his letter underscores his confusion about why the FDA is stopping people from getting non-controlled, regular prescription drugs now. He wants to know specifically if there is a change in FDA’s overall enforcement policy.
I’ve been warning about the serious public health ramifications of overzealous FDA enforcement on access to affordable medication for a long time. In 2015, I wrote a report about online pharmacies and personal drug importation, and sent it to the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.
Back in 2006, Senator Nelson played the leading role in ending stepped-up enforcement efforts by U.S. Customs and Border Patrol in which tens of thousands of prescription orders were seized on their way to patients. In October 2006, Customs announced it would no longer seize the international prescription orders. Small quantities of medication imported for an individual’s use are sometimes refused by FDA, but such actions have not greatly impacted Americans ordering online from pharmacies that require a prescription.
Sen. Nelson’s letter notes that the people from the pharmacy storefronts help older Americans “navigate the Internet to order the drugs they need at lower prices from legitimate pharmacies in Canada and other countries.” I was heartened to learn in Kaiser’s earlier reporting that many of the storefronts use PharmacyChecker Verifications to identify reputable international pharmacies.
To sum it up: Senator Nelson’s letter shows his serious concern that federal actions against personal imports will mean that more of his constituents won’t be able to afford medication. He is also concerned that the actions against pharmacy storefronts represent a new policy by the FDA under President Trump and Commissioner Gottlieb. To date, the FDA claims there is no new policy.
I hope Sen. Nelson gets the answers he wants and his constituents the medication they need at a price they can afford.Tagged with: Bill Hepscher, Enforcement, OCI, Scott Gottlieb, Storefront