For the benefit of consumers, I published a longish but straightforward explanation of the state wholesale drug importation bills, laws, and programs and how they differ from personal importation. I reviewed the drug relabeling section of Florida’s Drug Importation Program submission to the U.S. Department of Health and Human Services, and it really tells a story. Many if not most of the drugs that states propose to import from Canada are not made in Canada or the U.S. Both countries import a majority of their pharmaceuticals. They often come from the same countries and factories and are the exact same drugs. The reason the prices are so high in the U.S. is usually blamed on patents, which lead to what some call monopolistic pricing. Another reason drug prices are so much higher in the U.S. is that drug manufacturers have had a monopoly on commercial importation. It’s a very special protection that states are trying to remove through these programs.(more…)
With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada. Regardless, several states have passed laws toward creating importation programs: Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont. Simple summary: Canada’s brand drugs are priced much lower and states want access to them. These state laws have largely been confined to wholesale drug importation. That is, until this week when California Assemblymember Sydney Kamlager introduced the Affordable Prescription Drug Importation Act, AB 458. The bill not only calls for wholesale importation from Canada – but also personal drug importation from Canada and other countries, subject to Section 804 of the Food, Drug, and Cosmetic Act. It’s about time!
The bill states:
“This bill would authorize an individual to import a prescription drug only for use by that individual or a member of that individual’s immediate family from a foreign pharmacy if specified requirements are met. The bill would prohibit an individual from, among other things, importing a prescription drug for resale or a controlled substance.”
This is a huge step in the right direction because Americans are already buying medications internationally. Millions have done so from safe international online pharmacies – and the law technically permits this through enforcement discretion, but they should have “express permission.” As I stated in a press release yesterday:(more…)
This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose importation. Notably, it addresses the Canadian government’s valid concerns about new drug importation channels from the United States aggravating Canadian drug shortages.
Last year, just before the Section 804 rule went into effect, the Canadian government issued an interim order mandating that Canadian wholesale pharmacies not export drugs that could create or exacerbate domestic drug shortages. Certain drugs will require proper supply reporting before approved for export. The pharmaceutical industry’s flawed and, in some cases, false arguments against importation invoking drug safety issues are not working to stop the momentum on Section 804 state programs. In the industry’s public relations and lobbying efforts against the program, they often highlight Canada’s understandable and protective response. That won’t work either.
Colorado’s RFP is clear in its obligation to not cause drug shortages in Canada. A full quote from the proposal is in order here:(more…)
Here’s a kind of funny story to end the year with. I make a big deal on these pages about the decriminalized reality of personal drug importation. Federal law prohibits under most circumstances importing prescription drugs for your own use, but people are never busted for it. I’ve been around this a long time and I mean never. But that’s for personal use only. Recently, 20 U.S. air marshals in Dallas, Texas were disciplined for “smuggling” Viagra into the United States. They bought it at lower prices outside the U.S., brought it back, and gave it to their colleagues or sold it for a “small profit,” as reported in Yahoo News. So, are they in any real trouble?
It appears the answer is not really—at least not yet. The names of the air marshals are not public because they have not been charged with a crime. Some were suspended for a few days. One resigned. No one was terminated. However, two may be terminated based on “evidence uncovered during the investigation.” I would guess that those two were dabbling in the resale of stronger pharmaceuticals.(more…)
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
Canada’s Order Against U.S. Drug Imports to Prevent Shortages Directed at Wholesale Not Patient Purchases
Canada issued an interim order on Friday, November 27, preventing drug establishments from exporting products that would risk causing domestic shortages. The press release with quotes from Health Minister Patty Hajdu may be more digestible than the official order.
As I see it, Americans who rely on buying less expensive prescription drugs from Canada should not be too concerned about this new development. The order is directed at companies who distribute drugs via wholesale channels, not pharmacies that dispense drugs directly to patients. Patients in the U.S. with a valid prescription who safely order drugs from pharmacies in Canada do so through licensed retail pharmacies not wholesalers.(more…)Tagged with: Canada, drug shortages