In its lawsuit to stop wholesale drug importation programs that could help lower U.S. drug prices, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) may be stepping on its toes in helping to allow more personal drug importation. Last month, along with co-plaintiffs Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (“CAHC”), PhRMA sued the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to invalidate the certification by the HHS Secretary Alex Azar that drug importation from Canada is safe and will achieve savings for the American consumer.
In late September, Secretary Azar, in a final rule, certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. 384, Part L, poses “no additional risk to the public’s health and safety” and will “result in a significant reduction in the cost of covered products to the American consumer.” Those were the two certifications needed to allow a new wholesale drug importation channel.
Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J). As explained below, the standard for allowing personal importation is different. While PhRMA does not want either wholesale or personal importation to lead to lower drug prices, certain legal arguments it employs in its lawsuit may help the cause of expanding personal drug importation. Namely, personal drug imports can be permitted if they don’t pose an “unreasonable risk” to the patient; not so for wholesale imports (drugs that are resold). PhRMA ignores this.
(more…)Tagged with: Alex Azar, cahc, phrma, PSM
Drug Companies Front and Center at PSM Interchange Conference
Two weeks ago I brought you some highlights of the PhRMA-led Partnership for Safe Medicines (PSM) Interchange propaganda show, which was held on September 18th. Look over to the left. See that picture. Those logos of big pharmaceutical companies make it abundantly clear who is pushing the distorted message of PSM about personal drug importation and online pharmacies.
I’m not joking about the word “propaganda” applied to the PSM event. The online Merriam Webster dictionary provides the following definition for that word: “ideas or statements that are often false or exaggerated and that are spread in order to help a cause, a political leader, a government, etc.” In this case, as I see it, the “cause” of PSM is the commercial agenda of the pharmaceutical and U.S. pharmacy industries cynically couched behind terms of patient safety. A central message of PSM is that Americans are risking their lives buying medication online from other countries and that there is no way to do so safely. Those are false and exaggerated messages that are potentially leading lawmakers and regulators to overreact and scare Americans from a potential lifeline of affordable prescription drugs. Evidence shows that this has been PhRMA’s communications strategy for more than a decade. (more…)
Tagged with: Counterfeit Drugs, daniel burke, FDA, Interchnage, laganga, Mississippi AG hood, OCI, Partnership for Safe Medicines, phrma, PSM
In George Orwell’s famous novel 1984, published in 1949, we find a future in which totalitarian, one-party rule has run amuck on a global scale. It is a world in which whatever “The Party” (think Communist or Nazis) states is a fact must be believed, regardless of the obtuse logic and propagandistic origins of that so called “fact.” The quintessential and frightening example provided by Orwell is the notion that 2+2=5 if The Party Say’s so. When I attended the Partnership for Safe Medicines (PSM) conference last week, it felt as if many people were willing to believe absurd notions about online pharmacies. Most positions espoused at PSM’s conference support the following fallacious statement: IF an online pharmacy is not based in the U.S. and sells prescription drugs to the U.S. THEN it is dangerous. They essentially put on a show in which different people in a myriad of ways communicate that 2+2=5.
The event, called the PSM Interchange, is a Lion’s Den with many people who are directly paid by drug companies, indirectly paid by drug companies, U.S. pharmacies or their trade groups, or those who would like to be paid by the aforementioned entities someday, either directly or indirectly. PSM’s stated mission, “working together to protect the safety of your prescription drugs,” is, it seems, a smoke screen for big drug companies working together to keep drug prices as high as possible in their most cherished market – America. (more…)
Tagged with: CanaRx, Kenneth "mac" McCall, Libby Baney, Maine, Partnership for Safe Medicine, Peter Pitts, phrma, PSM, Todd Brown