by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jun 23, 2016 | FDA, Government, Online Pharmacies, Policy, Politics
“I represent safe and affordable imported medication. This bathwater is dangerous rogue pharmacy websites!”
Earlier this month, the U.S. Food and Drug Administration published a press release about Operation Pangea, an annual global initiative led by INTERPOL “to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.” This is the ninth annual operation, and each year I wonder if FDA will throw the baby out with the bathwater.
There are, according to FDA’s own sources, tens of thousands of drug-selling websites. Most of them are considered “rogue” by PharmacyChecker.com. Where the FDA and Operation Pangea successfully shut down sites (whether lawful or not) that intentionally sell counterfeit medications, or even online pharmacies that sell real medications but without the qualifications or pharmacy safety protocols to do so, we applaud their actions. Shutting down dangerous online pharmacies – throwing out the bathwater – is noble.
In February of last year we submitted a policy paper that I wrote to congressional committees with jurisdiction over laws and regulations that affect access to safe and affordable medications. Entitled “Online Pharmacies, Persona Drug Importation, and Public Health,” I argued that safe international online pharmacies are a boon to public health because they enable consumers to afford prescribed medications, and that overzealous enforcement of drug importation regulation could negatively affect access to those sites. Actions taken by FDA and through Operation Pangea would seem to cross the line from public health to Big Pharma profit protection where they curtail access to the safest international online pharmacies, which is throwing out the baby.
(more…)
Tagged with: Interpol, pangea
by PharmacyChecker.com | Mar 4, 2016 | Drug Importation, Drug Prices, Government
Yesterday, our CEO, Tod Cooperman, MD, applauded leading presidential candidates for supporting legal reforms to make it easier for Americans to buy lower cost medications from other countries.
“With millions of Americans doing this safely for more than a dozen years, it’s time for our government to stop threatening and scaring consumers and simply do what’s right: Make personal drug importation fully legal. Every presidential candidate should support this,” says Dr. Cooperman.
To read the full press release, go here: http://www.pharmacychecker.com/news/trump-clinton-sanders-support-drug-importation.asp.
Tagged with: Bernie Sanders, Donald Trump, Drug Importation, Hilary Clinton, Tod Cooperman
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jan 22, 2016 | Drug Prices, Government, Online Pharmacies
Unfortunately, public scrutiny about high drug prices doesn’t usually lead to legislative fixes, such as passing legislation that would allow Medicare to negotiate drug prices with the pharmaceutical industry and expand the practice of safe personal drug importation so more consumers access lower prices from foreign pharmacies. On the other hand, a New York Times article – “Even Talking About Reducing Drug Prices Can Reduce Drug Prices” – suggests, well, that “talking about” drug prices can reduce them, because pharma executives get scared that if they don’t moderate drug prices, more permanent and progressive fixes will finally happen.
(more…)
Tagged with: Bernie Sanders, Big Pharma, Drug Prices, Hilary Clinton, House Committee on Government and Oversight, Marco Rubio, Martin Shkreli, Medicare Improvement and Modernization Act of 2003, Medicare Part D, New York Times
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 20, 2015 | Advocacy, Drug Importation, Drug Prices, FDA, Government
Today, as the Obama administration hosted a “public” forum (think invitation only) about pharmaceutical innovation, access and affordability, I announced the formation of a non-profit organization dedicated to helping Americans get justice when it comes to prescription drug prices: Prescription Justice Action Group (PJAG). Whereas the administration’s public forum ignored personal drug importation, PJAG is providing guidance to Americans on what to do if their prescription drug orders are refused import by the FDA so they can try to have their medications released.
For about fifteen years, tens of millions of Americans have purchased medication from outside the U.S. –usually ordering it online. They do it because they want to save money or they really cannot afford the medication here at local pharmacies. The fact is that it has become a lifeline of lower cost medications for Americans.
But a new law – Section 708 of the Food and Drug Administration Safety and Innovation Act – gives the FDA expanded powers to destroy your personally imported medications, whether bought from a Canadian, Indian, Turkish or U.K. pharmacy. That doesn’t mean they will. It just means that they can. That law became effective over a month ago, and we haven’t heard of increased FDA seizures and destructions of international prescription orders.
The FDA has stated, and we have re-affirmed on our blog and main website, that under most circumstances it’s technically illegal to import prescription medication for personal use. But is it really? Is it always?
Section 708 allows the FDA to detain and potentially destroy your prescription order if it appears to be misbranded, unapproved, counterfeit or adulterated. If they take your adulterated or counterfeit drugs then the FDA has done their job. Misbranded or unapproved drugs, in contrast, could be entirely safe and effective medications, the same or foreign versions of the ones you buy in the U.S., but much less expensive. Under Section 708, you must be notified by the FDA if they take your prescription drug import, and you have 20 days to challenge them on their action. PJAG, in consultation with legal advisers, believes that you can make a good case that FDA should not destroy the medication but instead send it to you.
There are many dangerous online pharmacies out there from which you don’t want to buy or import medication. We call them rogue online pharmacies. But if you import a genuine, safe and effective medication, one that was purchased from a PharmacyChecker.com-approved online pharmacy and you get a notification from the FDA telling you that your prescription drug order is subject to destruction…PJAG!
Tagged with: affordable prescriptions, Drug Importation, FDA, Food and Drug Administration Safety and Innovation Act, international pharmacies, Online Pharmacies, pjag, Section 708
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 6, 2015 | Drug Importation, Drug Prices, Generic drugs, Government
Americans should know about the heat coming down against the pharmaceutical industry from certain members of Congress in an effort to combat the public health crisis of high drug prices. This week, nine lawmakers from the House of Representatives announced the formation of a new group called the Affordable Drug Pricing Task Force. Its goals are clear, to lower cost barriers to life saving medication and to demand greater transparency about drug cost decisions made by the pharmaceutical industry.
Two pertinent facts were continually raised. One, high drug prices are the No. 1 healthcare issue in America. Two, medication prices are much lower in other countries, about 50% lower in the UK.
To announce the task force, a press conference was led by Congressman Lloyd Doggett (D-TX) and included speeches by Rep. Sander Levin (D-MI), Rep. Jan Schakowsky (D-MI), Rep. Jim McDermott (D-WA), Rep. Rosa DeLauro (D-CT), Rep. Peter Welch (D-VT), Rep. Marcy Kaptur (D-OH), Rep. David Cicilline (D-RI), and Congressman Elijah Cummings (D-MD). We wrote about Rep. Cummings’ efforts a couple of weeks back as Congressman Cummings noted PharmacyChecker.com as a supporter of the Prescription Drug Affordability Act of 2015. I also want to note thank Congresswoman DeLauro for recently becoming a co-sponsor of the Personal Drug Importation Fairness Act of 2015.
The speakers have supported a variety of solutions to lowering drug prices, including allowing Medicare to negotiate drug prices with pharmaceutical companies; ending “pay-for-delay,” a practice sometimes described as payoffs by brand drug patent holders to generic drug companies to that the latter will postpone launching a lower cost generic; reforming prescription drug importation laws to make it easier to access lower cost medications from other countries; and greater oversight into pharmaceutical industry pricing practices.
Some highlighted quotes or phrases:
- “If the people are not able to afford their prescriptions that means they suffer and in some instances they die.” Rep. Cummings.
- McDermott’s take: “The pharmaceutical companies have got the Congress in the palm of their hand and they will not let us go.”
- The problem of high drug prices was referred to as an “emergency situation” by Rep. Sander Levin.
It’s no secret that I support much of this agenda. But what is needed is bipartisanship, and I’m waiting for these leaders, as part of their noble effort, to consider looking critically at the Obama administration’s record on personal drug importation and online pharmacies. Candidate Obama in 2007 supported reforming the law to make it easier for Americans to import lower cost medication. Unfortunately, in its efforts to pass the Affordable Care Act, which I supported, the Obama administration made a deal with big pharma to change course and dump drug importation legal reform in exchange for pharma’s support for Obamacare and agreement to new discounts on Medicare Part D medications through the coverage gap (the “Donut hole”).
On that final note, the Obama administration, though the Department of Health and Human Services (HHS), has announced a forum on drug prices to be held on November 20th. Maybe we’ll learn that the Obama administration’s position on prescription drug importation has returned to one more in line with most Americans. We’ll keep our fingers crossed.
(You can view the complete press conference below)
Members of the newly formed Affordable Drug Pricing Task Force will hold a press conference announcing meaningful action to combat the skyrocketing costs of pharmaceuticals. Who: Reps. Cummings, Doggett, McDermott, DeLauro, Schakowsky, and Welch.
Affordable Drug Pricing Task Force Press Conference – Nov 4, 2015
Tagged with: Affordable Drug Pricing Task Force, Congress, David Cicilline, Drug Importation, Elijah Cummings, generic drugs, Jan Schakowsky, Jim McDermott, Marcy Kaptur, Online Pharmacies, Personal Drug Importation Fairness Act, Peter Welch, Rosa DeLauro, Sander Levin, United States
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Oct 23, 2015 | Drug Importation, Government
In his article for AFRO – “A Growing National Outcry for Lower Prescription Drug Prices” – we were pleased to be noted by Congressman Elijah Cummings (D-MD) as a supporter of the Prescription Drug Affordability Act of 2015, and one of several organizations, including Public Citizen, Families USA, and Knowledge Ecology International that “speak of millions of Americans.” The bill was also introduced in the Senate by Senator Bernie Sanders (I-VT), who is a candidate for the Democratic Primary.
Rep. Cummings highlights the fact that American public opinion is overwhelmingly in favor of legal and regulatory reform to bring down drug prices. His legislation calls for Medicare to negotiate drug prices with drug companies, ending “pay-to-delay” deals, which are often characterized as payoffs from brand to generic drug companies to postpone introducing a lower cost generic, and reforming drug importation laws to expand our access to lower cost medications in other countries.
PharmacyChecker.com is not taking sides in a partisan fashion. Republicans, Democrats, and independents agree on the urgency of tackling drug prices in America. Sen. John McCain (R-AZ), Charles Grassley (R-IW), and David Vitter (R-LA) have all introduced and sponsored drug importation reform legislation over the past few years that we support. Another example is Republican presidential candidate Mike Huckabee, who wrote an op-ed strongly in favor of legal reform of drug importation to help Americans buy lower cost medications from Canada.
The most critical factor is that we move in the right direction towards expanding access to affordable medication, and we salute Congressman Cummings for doing so.
Tagged with: Bernie Sanders, Charles Grassley, Congress, David Vitter, drug importation reform legislation, drugs from canada, Elijah Cummings, John McCain, Mike Huckabee, personal drug importation, Prescription Drug Affordability Act of 2015
