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
Tagged with: Canada, Canadian pharmacies, CMPI, Peter Pitts, Pfizer, phrma, thurston, utah
I’m telling you Canadian drugs are safe but vote against importation.
In the Utah House of Representatives, Health and Human Services Committee, there was a meeting a few weeks back to discuss Rep. Norman Thurston’s drug importation bill. The bill’s aim is to lower prescription drug costs for Utah by importing lower-cost medications from Canada. The committee passed it 9-2. A week later, the Utah House passed the bill 39-31! But in that committee meeting, during the public session where organizations came out in favor and against the bill, something unique happened.
During his remarks against Thurston’s drug importation bill, one Mr. Peter Pitts said, and I quote from the audio clip: “I will tell you one thing in defense of Canada…If you drive up across the border and you go to a brick and mortar pharmacy and you get a product. That product is safe and effective; just as safe and effective as a U.S. product.”
I’ve followed and written about Big Pharma’s positions on importation for over 15 years. Its mantra and that of its hired guns is that the U.S. system for regulating pharmaceuticals is the world’s “gold standard.” As you’ll discover, Mr. Pitts, as I see it, is one of those hired guns and a notable one. Therefore, it’s great and fun to have him on the record, clearly (emphatically) stating that Canada’s system for regulating prescription drugs and the drugs sold in Canadian pharmacies are just as good as the ones sold here. That means Canada is the Gold Standard, too!
Listen to the whole hearing.
Note to all my fellow Americans that didn’t already know: if you live close to Canada and can’t afford your medication, then, according to Mr. Pitts, the medication there is damn good…not to mention a lot less expensive. Did you also know that federal law bans U.S. Customs Border Patrol from preventing people who are traveling back from Canada from importing small quantities of prescription drugs when they are for personal use? See: Can I drive to Canada to fill a prescription?
Who is this guy? Who cares? (more…)
This week I’m down in Washington, DC, talking to policy-makers and activists, setting off alarm bells about Big Pharma’s campaign to not only kill prescription importation legislation but also the ability for Americans to currently buy medications from Canada and elsewhere at all. I have a feeling Big Pharma knows I’m here, which is kind of cool (but also freaks me out because they are very powerful and we are not). Here’s the very quick story.
When I searched “pharmacychecker” in Google I noticed the top advertisement was placed by none other than the Pharmaceutical Researchers and Manufacturers of America (“Big Pharma”). That ad doesn’t show up in Brooklyn where I live but appears targeted in Google to the DC area. They know that our pricing information, verification work we do for patient safety, and advocacy is compelling to some public policy and healthcare advocates down here, so they pay Google to get their message on top. As if Big Pharma’s 1100 lobbyists aren’t enough!
It’s a badge of honor (but there’s no sleep til Brooklyn).
Tagged with: Brooklyn, DC, phrma