Reviewing the draft Food and Drug Administration Globalization Act, I agree with the testimony of Biotechnology Industry Organization President and CEO Jim Greenwood last week to the House Engergy and Commerce Subcommittee on Health: “this ‘closed’ system for imported drugs and drug products is an essential element in ensuring drug safety in the US. Efforts to broaden importation of drugs will undermine efforts to strengthen the system and add to the FDA’s already heavy burden.”
I wonder, however, whether during the development of this act there was sufficient consideration into expanding authorization (to FDA?) to monitor online vendors and distributors. Certainly, the increasing number of drug products, legitimate and otherwise, available online has not escaped the attention of lawmakers. And it seems fitting that a law covering true globalization issues would not ingore this obvious hole in the “closed” system of drug distribution.
FDA already monitors these websites and has issued (virtual) warning letters to companies claiming FDA-approved products or supplements offering therapeutic value. What if increased funding to monitor overseas manufacture and distribution also included funds to monitor online distributors?
Before you reply with a caveat emptor, consider this: More than 80% of online “pharmacies” do not require a prescription and even FDA has suggested this may be the primary reason (more than cost) that users turn to online pharmaceutical purchase. Online pharmaceutical marketing is not going away anytime soon, and it’s time to include it in true global industry monitoring.