by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Dec 21, 2017 | FDA enforcement
Standing up for his constituents on drug prices
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 (more…)
Tagged with: Bill Hepscher, Enforcement, OCI, Scott Gottlieb, Storefront
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 21, 2017 | FDA
November 20, 2017 — Kaiser Health News reported that the FDA Office of Criminal Investigations sent agents and search warrants to several companies in Florida — often referred to as pharmacy storefronts — because they help Americans place orders and fill prescriptions with pharmacies located in Canada in addition to other countries.
Read the full story here: FDA Raids Florida Stores That Consumers Use to Buy Drugs from Canada
The FDA has a lot of regulatory latitude to shape its enforcement agenda. Its efforts against counterfeit drug sales, opioid pushers (including drug companies), and rogue websites can greatly protect public health. However, we know that FDA/OCI has a history of actions more focused on protecting the profits of pharmaceutical companies.
PharmacyChecker.com opposes enforcement actions that target the safest international pharmacy options, whether via online pharmacies or storefronts, on which many Americans have come to rely because they can’t afford medications locally.
FDA has informed storefront operators that prescription drug importation is illegal and that they could face fines or jailtime for helping Americans buy lower-cost medication. (more…)
Tagged with: Enforcement, Florida, opioids, storefronts
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Oct 23, 2014 | Counterfeit Drugs, FDA, Rogue Online Pharmacies
When you’re fighting for something you believe in sometimes you lose perspective, and that can lead to overreaction and self-righteous indignation. I’ve been very critical of the FDA because I believe the agency is not doing right by Americans consumers on the issue of online pharmacies and personal drug importation. FDA seems incapable of admitting that there are safe international online pharmacies that help Americans afford medication, and its BeSafeRx program is right out of the big pharma playbook; and…wait, wait, there I go again…
The FDA, specifically its Office of Criminal Investigations, expends a lot of time and energy tracking down people who are intentionally selling fake, expired, or otherwise clearly dangerous pharmaceuticals. Those efforts save lives and ought to instill fear in those perpetrating these acts or those considering doing so. We should and do applaud FDA for those efforts. (more…)
Tagged with: Enforcement, OCI, Office of Criminal Investigations, public health
