by PharmacyChecker.com | Mar 6, 2015 | Pharmacychecker Online Pharmacy Report
To see just how drug company lobbyists snake their way into the legislative process please read this next section, which follows the executive summary.
You can view the whole report here.
The GAO inquiry into online pharmacies mandated by FDASIA in its Section 1127 was drafted by a lobbyist in the employ of a government relations firm (FaegreBD Consulting) hired by the Alliance for Safe Online Pharmacies (ASOP), a group that is led by Eli Lilly, the National Association of Chain Drugstores and LegitScript.The executive director of ASOP is Libby Baney, who now runs a consulting firm called FWD Strategies International.1 According to its website, FWD Strategies International “is not just a name; it is what we do – moving your vision forward.” In marketing her firm, Ms. Baney notes that one of its services is drafting congressional legislation. As an example of draft legislation, she notes Section 1127 of FDASIA among others relating to online pharmacy.
As evidenced above, it’s not surprising that Section 1127 did not encourage the GAO to perform serious research and independent analysis about online pharmacy safety. Instead Section 1127 conspicuously calls for GAO to report on “laws, policies, and activities that would educate consumers about how to distinguish pharmacy Internet web sites that comply with Federal and State laws and established industry standards from those pharmacy Internet websites that do not comply with such laws and standards…” That language represents the “vision” of the founders and funders of ASOP, companies and people with a history of working to curtail access by Americans to lower cost medication from safe international online pharmacies.2
1 Libby Baney is identified as a lobbyist for the Alliance for Safe Online Pharmacies in this lobbying disclosure report: http://soprweb.senate.gov/index.cfm?event=getFilingDetails&filingID=6B1B406C-D5C0-48C6-9484-B9FF3B372B1F&filingTypeID=51 [Last accessed 10/21/2014].2 Some of ASOP’s funders seek extreme actions, such as “delisting,” to achieve their goals. Eli Lilly recommends that search engines remove organic results so that Americans can no longer find online pharmacies that are not based in the U.S. See, testimony by Bruce Longbottom, JD, Eli Lilly, Statement to the House Energy and Commerce Committee, Subcommittee on Oversight and Investigations, February 27th, 2014, see http://docs.house.gov/meetings/IF/IF02/20140227/101804/HHRG-113-IF02-Wstate-LongbottomB-20140227.pdf [Last accessed 10/24/2014]. View the actual testimony about delisting here.
Tagged with: 1127, Alliance for Safe Online Pharmacies, ASOP, Eli Lilly, faegre, FDASIA, FWD Strategies International, GAO, Libby Bainey, lobbyist
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 5, 2015 | Drug Importation, Drug Prices, Generic drugs
At the beginning of this year, we brought you the story of Lu Yong, a Chinese citizen with Leukemia who was facing severe financial hardship due to the $3,783 monthly cost of his cancer medication, Gleevec. Mr. Lu found out he could order Veenat, a generic version of Gleevec, from India for a more affordable $640 a month. Soon thereafter he started helping fellow Leukemia sufferers – a thousand of them – access Veenat, in effect helping save their lives. Mr. Lu was rewarded by being charged with selling counterfeit drugs and credit card fraud!
The problem was that Veenat, an entirely genuine, legally manufactured and effective medication approved in India, is designated as “counterfeit” and unapproved in China. The credit card fraud charge was brought because Mr. Lu used other patients’ credit cards to order their medicine.
So, our earlier blog post on this story was called “Low Cost Counterfeit Drugs Save Lives in China…What?!” Seem like a stretch? Not really. Medication deemed “counterfeit” was in fact saving lives. A Chinese court seemed to agree, determining that Mr. Lu’s action should not be construed as “selling counterfeit drugs” since the medication was genuine. Additionally, because his use of other people’s credit cards was to help them, it was not “criminal behavior.” For more read about it in Chinese Radio International.
Lu Yong is a prescription access hero and we applaud him rancorously. Kudos to the Chinese legal system as well.
Tagged with: China, generic gleevec, Gleevec, lu yong, veenat
by PharmacyChecker.com | Feb 27, 2015 | Pharmacychecker Online Pharmacy Report
Last week we wrote that we would present a new section of Gabe Levitt’s report on online pharmacies. This week, we are going to start off with the Executive Summary of the report. We’ve given a sample below, but you’ll have to visit PharmacyChecker.com to view the whole Executive Summary.
The U.S. government relies on the Government Accountability Office (GAO) for objective and independent research and analysis of government programs and policies that affect public health. GAO’s report entitled Internet Pharmacies: Federal Agencies and States Face Challenges Combatting Rogue Sites, Particularly Those Abroad (the “GAO report”) contains critical inaccuracies and omits important peer-reviewed research to the extent that lawmakers and their staffs will likely draw erroneous conclusions about international online pharmacies that could lead to overreaching and unnecessary enforcement actions that disadvantage consumers and threaten public health. The GAO report was written pursuant to Section 1127 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), a law dedicated to protecting public health.
In contrast to the GAO report, the following holistic, consumer-focused, evidence-based analysis discusses online pharmacies within the important context of a health crisis caused by high drug prices in America, and can more appropriately guide lawmakers on how to protect the public from counterfeit or substandard medication. Legitimate public health concerns about rogue online pharmacies are being used to encourage legislative, regulatory, and private sector actions that curtail online access to safe and affordable medication. The consequence of overreach could be millions more Americans facing economic hardship or having to forgo prescribed medication, which studies show can lead to more sickness and death.
Fifty million Americans did not fill a prescription due to cost in 2012, according to the Commonwealth Fund. According to the Harvard School of Public Health, over half of Americans who do not take prescription medication due to cost report becoming sicker.1 That means potentially 25 million Americans become sicker each year because they can’t afford prescribed medication. According to the U.S. Centers for Disease Control and Prevention (CDC), about five million Americans buy prescription drugs from foreign sources each year for reasons of cost. Additional estimates show that between four and five million Americans get their imported prescription drugs through international online pharmacies due to their lower prices.
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Tagged with: CDC, Commonwealth Fund, drug affordability, FDASIA, GAO, government auditing standards, Medication Adherence, Section 1127
by Tod Cooperman, MD, President, PharmacyChecker.com, and Gabriel Levitt, Vice President, PharmacyChecker.com | Feb 26, 2015 | Drug Importation, Government, Personal Drug Importation
Unfortunately, a Maine state law that was created to help people access lower cost medication from licensed pharmacies in Australia, Canada, New Zealand and the United Kingdom, was invalidated yesterday in a decision by federal court Judge Nancy Torresen. Basically the judge, invoking a legal doctrine called “preemption,” concluded that federal law beats state law when it comes to foreign commerce, and since federal law technically bans personal drug importation under most circumstances, Maine’s law is trumped. I’ll return at the end to deal with a little legalese fun (but not too much!).
Taking a walk down memory lane here: personal drug importation programs in Maine, such as one operated for the City of Portland, Portland Meds since 2004, which has helped Americans save many millions of dollars, were shut down in 2012 by former State Attorney General William Schneider. The programs were shut down because Maine’s pharmacy groups persuaded AG Schneider that Canadian and all foreign pharmacies should be stopped from mail order pharmacy sales into Maine because they are not licensed in Maine. Most U.S. states require pharmacies based elsewhere to obtain an out-of-state pharmacy license if they want to sell medication by mail to their residents. While there are exceptions, most states do not allow pharmacies in other countries to obtain an out-of-state license.
Maine legislators were angered by this action and passed a law, LD 171 “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” that exempted licensed pharmacies in Australia, Canada, New Zealand, and the UK from having to obtain an out-of-state Maine pharmacy license. Not only was this law passed on a bi-partisan basis but the vote was overwhelming: Maine’s House voted 107-37: the Senate voted 30-4. And with that the personal drug importation programs resumed.
The law was invalidated, now what?
Programs like Portland Meds will not necessarily shutdown. We’ll have to wait and see what happens. But if they do shutdown then thousands of Mainers will be paying more for their medications. More seriously, some Mainers will likely end up skipping their medications because the prices at their local pharmacies are too high for them. Back in 2012, an owner of one company that worked with CanaRx, a Canadian pharmacy benefit company, admitted that by working with licensed foreign pharmacies his company saved money: but there was more to the story than simply a company saving money. Quoting a journalist from the Bangor Daily News:
While acknowledging that Hardwood Products “as a company is trying to save money,” Young said his greatest fear is that a spike in costs will spur his employees to stop taking medications for conditions such as diabetes and asthma.
“We have many people here who are hourly employees,” he said. “We pay a fair wage, but the impact out of the family net income will be significant. More important than the money is the health and well being of the employees and their families. What dollar figure do you put on that?”
…but all hope is not even close to lost! Americans still have access to safe and more affordable medication available online, and, again, Maine’s programs have not yet shut down. Equally as important to the longer term cause of prescription justice, the ruling leaves the door open for the State of Maine to appeal the decision up the legal food chain to the 1st Circuit Court of Appeals in Boston. If Maine wins then other states may follow its lead by passing similar legislation to promote access to lower costs medications from other countries.
I’m pretty certain that, with the requisite political will from Maine’s legislators, citizen rabblerousing, and some good legal marksmanship, there are ways to overcome and defeat Judge Torresen’s ruling.
To conclude, I’d like to challenge something Judge Torresen opined in her ruling to nullify Maine’s foreign pharmacy law:
“Congress enacted the FDCA [Food, Drug and Cosmetics Act] to bolster consumer protection against harmful products.”…In furtherance of this purpose, Congress has created a complex regulatory scheme covering the importation of pharmaceuticals into the United States…
Is that so? Maybe…in part. However, I believe that banning Americans from importing lower cost and safe prescription medication from licensed pharmacies for their own use does nothing to bolster consumer protection against harmful products but quite a lot to bolster protection of big drug company and U.S. chain pharmacy profits. I know that the ban impedes Americans from taking medications they need and forces more financial hardship. Are these facts that could hold up in court? I think so.
Tagged with: CanaRx, legal, Maine, Torresen
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 19, 2015 | Pharmacychecker Online Pharmacy Report
Correcting the Public Record about Online Pharmacies and Personal Drug Importation
In July of the 2013, the Government Accountability Office (GAO) published a report about Internet Pharmacies with a focus on foreign websites that I believe strongly distorted the public record about buying medication online through personal drug importation. GAO’s report was submitted to Congress in response to Section 1127 of the Food and Drug Administration Safety and Innovation Act, intended to protect the public health. I wrote a report to refute the GAO’s positions in order to correct the public record regarding the intersection of online pharmacies, personal drug importation, drug affordability and the public health. I believe that my report about online pharmacies proves that the GAO’s efforts fell very short in getting to the truth about buying medication online.
Americans buy lower cost and safe medication internationally, often online, and it benefits their health and financial well-being. If it were not for the option of personally importing lower cost medication, often using the Internet, many Americans would just not be able to get medical treatments they need. People who can’t take needed medication often get sick and may even die. The GAO report did not mention these facts.
The GAO seemed to conflate safe international online pharmacies with rogue online pharmacies in the same manner we’ve come to expect from the pharmaceutical industry, U.S. pharmacy trade associations and the FDA – by calling safe international online pharmacies “rogue.” The problem, for me, is that its lead author is not with the pharmaceutical industry, a U.S. pharmacy trade association, or the FDA. She is someone I’ve come to admire over the years just by following her work with GAO. So I can’t just say “look, it’s big Pharma again!” So for almost a year and a half I’ve written a report to, in part, prove to and remind myself that “we’re right and they’re wrong.” I’ve done that. I look forward to this report becoming a part of the public record.
Rogue online pharmacies, meaning drug-selling websites that are not safe (see my report for details), should be shutdown. Let’s get rid of them! However, if our elected leaders and regulators allow or enact policies to bring about an end to online access by Americans to safe and affordable medication and people get hurt, then they can’t say they didn’t know.
Below, I’ve pasted the cover letter from Tod Cooperman, MD, president of PharmacyChecker.com, and I that accompanied the hardcopy of the report we sent the congressional committees that received the GAO’s report in 2013. Each week we’ll be commenting on and posting the different sections of my report. To read the report now, visit “Online Pharmacies, Personal Drug Importation and Public Health”.
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Tagged with: GAO, Internet pharmacies, personal drug importation, public health, rogue online pharmacies
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 13, 2015 | Advocacy, Drug Safety, Online Pharmacy Verification Services
When it comes to prescription drugs and the public health, safety and affordability have to be considered together. People are at risk if they obtain medication that doesn’t work because it’s counterfeit, adulterated or substandard. At the same time, a perfectly safe and effective prescription drug will not help someone who cannot afford it. We help protect the public health by obtaining, verifying and providing information about online pharmacies and prescription drug prices that consumers can use to help maximize access to safe and affordable medication.
As we’ve said time and again, the key is to stay away from rogue online pharmacies by sticking with pharmacy sites publishing a valid PharmacyChecker.com seal, or accreditations from the Verified Internet Pharmacy Practice Sites program or LegitScript. Many members, but not all, of the Canadian International Pharmacy Association are verified by PharmacyChecker.com as well.
For healthcare providers and consumers looking to understand who we are, what we do, and how to use our information, we publish “Protecting the Public Health: Verifying Pharmacy Websites to Help Consumers Find Affordable Medication and Avoid Rogue Online Pharmacies.”
For those interested in more specifics on our online pharmacy safety policies, requirements and standards please see our detailed guidance document about our verification program.
We welcome your questions or comments about our programs and policies: info@pharmacychecker.com.
