by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 23, 2011 | Counterfeit Drugs, Online Pharmacies
A bill was introduced in the House of Representatives last week that would make repeat counterfeit drug offenders subject to 20-year maximum jail-terms with $4 million fines for individuals and $10 million if the defendant is an entity. PharmacyChecker.com applauds the introduction of H.R.3468, Counterfeit Drug Penalty Act of 2011, as we believe, if passed, it will act as a deterrent against individuals and businesses who endanger the public health by manufacturing and selling medication that is not subject to government regulations and oversight at best, and deadly at worst.
We also recognize that the bill’s language is clear not to blur the distinction between counterfeit and safe imported medication. The bill states:
Nothing in this Act, or the amendments made by this Act, shall be construed to apply to a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) solely because the drug is manufactured in or imported from a foreign country.
In contrast, the proposed Stop Online Piracy Act and Protect IP Act, now before Congress, defines all personally imported medicine, including genuine medication as a threat to the “public health.” This should be opposed. This language appears based on the lobbying rhetoric of the pharmaceutical industry to confuse lawmakers and consumers into believing the false proposition that all personally imported medicine purchased through online pharmacies is counterfeit. Thus, it’s a positive development that H.R. 3468 is crystal clear about the difference between counterfeit and imported drugs.
Stopping drug counterfeiters, whether they infiltrate the domestic supply chain by selling products to U.S. pharmacies or export dangerous drugs ordered online directly to Americans, protects the public health. The Counterfeit Drug Penalty Act seems to go after the real bad guys while not interfering with access to safe and affordable imported medicine and we hope it passes soon.
Tagged with: 21 U.S.C. 321, amendment, and Cosmetic Act, Congress, Counterfeit Drug Penalty Act of 2011, Counterfeit Drugs, counterfeiters, Drug, Federal Food, foreign, H.R. 3468, House of Representatives, importation, pharmacychecker.com, public health, Stop Online Piracy Act and Protect IP Act, supply chain
by PharmacyChecker.com | Jul 1, 2011 | Drug Importation, Online Pharmacies, Personal Drug Importation
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.
Our full submission can be accessed here.
Tagged with: Consumer Information, Docket No. FDA-2011-N-0259, Drug, Enforcement, FDA, NABP, Periodic Review of Existing Regulations
