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Death Penalty Medication Imported; Safe Prescription Drugs Banned – A Poor Prescription for America

EU FlagAlthough the U.S. technically bans the personal importation of affordable and safe drugs that help people stay or get healthy (for example Merck’s asthma medication Singulair, sold in other countries for a fraction of the price found in U.S. pharmacies, is not technically FDA-approved due to different packaging), we waive our drug importation laws when it comes to European Union-produced sodium thiopental – a non-FDA-approved version, for lethal injections.

Sodium thiopental is a required sedative in U.S. executions, and earlier this year the only U.S. manufacturer ceased producing it. For this reason, we now rely on EU imports – a practice that is getting more and more difficult, as export controls have been strengthened on their end because our EU allies oppose the death penalty.

We find it sad and ironic that our government facilitates the importation of a drug used for executions, regardless of one’s position on the death penalty, but refuses to loosen restrictions on personal importation for drugs that help Americans live.

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RxRights.org Message on Personal Drug Importation Picked Up on CNBC

Earlier this week, the head of RxRights.org, Lee Graczyk, issued a statement urging Congress “to exercise common sense and recognize that personal drug importation from legitimate, licensed pharmacies is a necessity for millions of Americans today.” Graczyk’s message was quoted in a CNBC article entitled, Why US Pays More for Health Care Than Other Nations. As a coalition member of RxRights.org, we are proud of the strong advocacy work they are doing to help seniors and all Americans gain access to affordable medication.

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Major Threats to U.S. Drug Supply, But Online Pharmacies Not Among Them According to Pew Report

Last week the Pew Charitable Trusts program on drug safety released its final White Paper about the major threats to the U.S. drug supply, called After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Online pharmacies are not among the major threats, according to Pew. Rather, the globalization of drug manufacturing and Byzantine domestic pharmaceutical distribution processes are the crux of the problem.

According to Pew, a major threat to the U.S. drug supply comes from importing active pharmaceutical ingredients and finished prescription drug products from facilities that have not been inspected by the FDA and on which we otherwise have too little information. The other major threat is attributed to the complicated nature of our domestic drug distribution system, in which literally thousands of wholesalers buy and sell prescription medication in a domestic grey market marred by loose and inconsistent regulations, state and federal.

It’s clear that Pew does not view international online pharmacies as a major threat to the U.S. drug supply, but they did make a few points of caution. The report reads:

Online pharmacies are another way that problematic products can make their way into the United States. While not examined in depth in this paper, there is no doubt that by indiscriminately purchasing drugs from online sources, consumers expose themselves to a large safety risk. While many legitimate online pharmacies exist, there have also been documented sales of counterfeit, diverted, misbranded or adulterated medicine through online pharmacies. (more…)

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PharmacyChecker.com Submits Comments to FDA Regarding Online Pharmacies and 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.

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CNN Report on Americans’ Search For Affordable Medication Spreads Confusion Not Clarity

CNN.com recently aired a video entitled Phony meds flooding U.S, which addressed a variety of dangers related to buying prescription drugs in Mexico, on the streets of Los Angeles, from unauthorized sources and from certain online pharmacies. While warning consumers about the dangers of bad medicine and fraudulent practices is good, the CNN piece, unfortunately, may confuse consumers about what the real threats are. With 120 million American consumers struggling to afford their medication, many are understandably looking for alternatives to the prohibitive costs of brand name drugs in the U.S. We believe our Consumer Guide, which does not recommend Mexican pharmacies, gives the best information on how to save money safely on your prescriptions, a summary of which you can find here.

Whether traveling to Mexico or ordering from international online pharmacies, Americans deserve to be properly informed and this CNN piece highlights how the message to consumers is often misleading, unclear and inaccurate.

The segment begins at a border crossing between Tijuana and southern California. CNN reports, “Everyday Americans flock across the border to buy deeply discounted prescription drugs”. Several Americans interviewed in the piece say they can get cheaper medications at Mexican pharmacies, at 50% off or more, and that it works for them. (more…)

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The Protect Intellectual Property Act – S.968 Will Prevent Access To Medicines

Last Thursday, the Senate Judiciary Committee unanimously passed S. 968, Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011, also known as the Protect IP Act. Its passage represents a real threat to Americans’ access to safe and affordable medications online and we hope that as the bill makes its way through the legislative process it will be amended appropriately.

Essentially, the bill will make it easier to crackdown on rogue pharmacy sites selling fake meds and not requiring a prescription, which is great; however, it will also encourage actions to block Americans’ access to reputable and affordable non-U.S. online pharmacies that sell genuine medication and require a prescription, which are a lifeline for uninsured Americans. That’s because of Section 5, which includes in its definition of “infringing sites” online pharmacies that sell medications to Americans that are not manufactured in a facility approved by the FDA. (more…)

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