Although 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.
In March of this year the FDA took the unusual step of allowing an “unapproved” compounded drug to remain on the market to explicitly make sure Americans could afford that product. That drug is hydroxyprogesterone caproate, branded by K-V Pharmaceuticals as Makena, the first FDA-approved drug to prevent the risk of preterm birth in certain women. Will more such government interventions continue in support of drug affordability?
According to the Wall Street Journal Blog,“Typically, whenever a drug is approved, pharmacy compounding isn’t allowed and the FDA acts to remove any unapproved drugs that might on be the U.S. market.” However, the FDA is allowing the compound to remain solely because of the outrageous cost for the brand-name product; Makena is priced at $1,500 per dose! Before Makena was approved, the same drug without the K-V branding and FDA stamp of approval cost between $10 – 20 per dose.
To the best of our knowledge, the FDA’s role does not include controlling prices to help Americans have access to the medication they need. However, that is precisely what the FDA did in the case of Makena. In our opinion, that’s also what the FDA does by not enforcing certain personal drug importation laws that, if enforced, would prevent Americans from affording needed medication. Currently, under its personal drug importation policy, the FDA has stated it does not take enforcement action against individuals who import non-controlled medicines, which are generally (and ironically) viewed as not FDA-approved even if they’re the exact same drug sold here, often due to labelling or pill color and shape differences between otherwise identical products. (more…)
A new post on RxRights.org explains how the National Association of Boards of Pharmacy (NABP)’s Internet Drug Outlet Identification Program wrongly misleads consumers and the media by tagging all non-U.S. online pharmacies that sell to Americans as “rogue.” Essentially, that program’s list includes dangerous rogue online pharmacies along with reputable online pharmacies that meet high standards of safety but are simply not based in the United States. American consumers should expect more from pharmacy regulatory authorities and deserve to be properly informed. By adding properly verified international online pharmacies to the list, NABP scares Americans away from safe and affordable sources of medication. RxRight.org alerts the public that NABP’s program was sponsored with a grant from the drug giant Pfizer.
The post also deconstructs the ridiculous notion that only “FDA-approved” drugs are safe. It explains that the same exact drug purchased from a Canadian pharmacy (or any non-U.S. pharmacy) that is sold in the United States is “Not FDA-approved.” How can that be if it’s the same drug? There are many reasons, but one primary reason is labeling. FDA-approved drugs include approval of the drug’s specific labeling. That means that virtually all drugs sold in Canada that are compositionally identical to those sold in the United States are not “FDA-approved” because their labeling is different (such as including information in French and English), but of course they are equally as safe.
PharmacyChecker.com applauds RxRights.org for exposing misinformation campaigns sponsored by the pharmaceutical industry meant to scare Americans away from safe and affordable online pharmacies, wrongly inform the media, and shape our nation’s laws and regulations.