Adding to the slew of recent articles on the drug importation issue, a just-released California Healthcare piece discusses a new proposal that would allow “not only individuals but drug wholesalers and pharmacies to buy from Canada.” Undoubtedly, this is music to the ears of corrupt wholesalers and pharmacies. It also makes me think this bill omitted a key piece of information-the requirement for a fresh supply of body bags, a line made famous from Rambo. Of course, this is hyperbole, but there is a speck of truth to it. Many over the years have asked for proof that counterfeit drugs have harmed U.S. consumers. Well, that question will certainly be answered should this new proposal become law. If state regulators and FDA are unable or lack the resolve to oversee wholesalers and pharmacies on supply chain issues, as they have been ever since the PDMA became law almost 30 years ago, how are they going to handle this insurmountable task? Congress needs to look at its own report on the NECC catastrophe and see that pharmacies are woefully understaffed, to the tune of just 5 inspectors per state. Who exactly is going to ensure the drugs traditionally at-risk secondary wholesale distributors are distributing and independent pharmacies are ultimately dispensing to vulnerable patients are coming from approved Canadian sources and not some illegitimate supplier in a van? How would such a practice even co-exist with the DSCSA? Entertaining such a proposal should occur only after our supply chain is fully secured, but we are a long, long way from that happening. While this bill might look good on paper, it would amount to a self-inflicted wound necessitating the type of rescue mission that even Rambo would walk away from.
- FDA’S OCTOBER 2018 DRAFT GUIDANCE ON DSCSA VERIFICATION SYSTEMS IS MIA June 17, 2019
- THE TIME HAS COME FOR NOVEL APPROACHES TO SECURING OUR NATION’S DRUG SUPPLY April 11, 2019
- FDA AND CBP TO INCREASE JOINT INTERNATIONAL MAIL FACILITY EFFORTS April 5, 2019
- FDA’S LONG OVERDUE NATIONAL WHOLESALE DISTRIBUTOR LICENSING STANDARDS March 14, 2019
- THE OPIOID ABUSE EPIDEMIC AND FDA’S LAW ENFORCEMENT MISSION CREEP March 1, 2019
- NOVEL FDA APPROACH TARGETING PHARMACEUTICAL FRAUD CASE BAGS PENNSYLVANIA DRUG COMPANY February 26, 2019