Per the FDA’s invitation for regulation reviews and comments as listed by the Federal Registrar, our vice president, Gabriel Levitt, submitted PharmacyChecker.com’s positions and suggestions pertaining to online pharmacies and personal drug importation.
Our first point is that there is inaccurate information provided for consumers on the FDA’s website relating to online pharmacies and drug safety. Consumers are misled to believe that any pharmacy not located in the United States is dangerous, or non-reputable, while experience and studies show that properly verified international online pharmacies are safe. Additionally, the FDA’s website communicates that only FDA-approved drugs are checked for safety and effectiveness, a claim for which there is no basis. In fact, some so-called “non FDA-approved” drugs are the exact same drugs made by Pfizer or Merck, for example, just labeled or colored differently.
We then recommend revisions to Section 9.2 of the FDA Regulatory Procedures Manual Imports and Exports, which guides FDA practices in enforcing our drug importation laws. We recommend that FDA’s personal drug importation policy explicitly disallow government officials from seizing personally imported prescription orders destined for Americans that they know are genuine and dispensed pursuant to a prescription. The ethical and economic basis for our recommendation is that prescription non-adherence (not taking your meds) often furthers illness, leading to more emergency room visits, costing the nation hundreds of billions in healthcare dollars.
Finally, we ask that the FDA ban enforcement actions against foreign companies that are known to operate safe international mail-order pharmacies. Studies show that cost is the number one reason that Americans do not take their medications, and cutting off access to these safe and affordable pharmacies means fewer Americans will take their prescribed medicines.Consumer Information, Docket No. FDA-2011-N-0259, Drug, Enforcement, FDA, NABP, Periodic Review of Existing Regulations