by PharmacyChecker.com | Jun 11, 2012 | Advocacy, Drug Importation, Healthcare Reform
It’s unfortunate, but now documented, that President Obama, who initially supported personal drug importation as a policy to lower drug prices, changed direction as part of a deal to gain the pharmaceutical industry’s support for his larger health care initiative. The details came out last week, as described in a New York Times article “Obama Was Pushed by Drug Industry, E-Mails Suggest.”
We hope that President Obama will return to supporting personal drug importation as the problem of high drug prices persists and tens of millions of Americans are going without needed medication. Although not publicly supporting it, fortunately, the government’s longstanding policy is not to interfere with individuals getting prescription medications from abroad. You can get information on licensed pharmacies and their drug prices on PharmacyChecker.com.
There are legislative actions in the works that could lead to a more aggressive enforcement policy through which personally imported medication could be destroyed. Americans can stop this from happening. Take action through RxRights.org to tell your elected officials where you stand.
Tagged with: Big Pharma, Drug Importation, Emails, Healthcare Act, Obama
by PharmacyChecker.com | Jun 8, 2012 | Advocacy, Drug Importation, FDA
The problem of Americans not taking medications is caused by high costs of prescription drugs, undesirable side-effects, health literacy, forgetfulness among other reasons. Medication non-adherence is a $317 billion problem. The U.S. Surgeon General and the Department of Health and Human Services issued a request to individuals and organizations to submit information about the national problem of medication adherence. Specifically, the government’s request presents “the opportunity to identify issues relevant to all levels of government, as well as individuals, health care providers, and industry and private organizations in efforts to improve medication adherence in adults with chronic conditions.”
Since cost is one of the critical factors inhibiting Americans from getting needed medication, we believe the government should take more proactive steps to provide useful information about how to obtain affordable medication online. Our analysis and recommendations are published below. For a PDF copy click here.
The Honorable Howard K. Koh, MD., M.P.H.
Assistant Secretary for Health
The Honorable Vice Admiral Regina M. Benjamin, M.D., M.B.A.
Surgeon General of the United States
Room 710-H
200 Independence Ave., SW
Washington DC 20201
Re: Request for Information on Prescription Medication Adherence
Submitter: Gabriel Levitt, Vice President, PharmacyChecker.com, 333 Mamaroneck Avenue, White Plains, NY 10605. (718) 387-4526, Gabriel.levitt@pharmacychecker.com.
Prescription medication non-adherence should be treated as a national crisis since so many Americans suffer as a result. Some of the reasons for non-adherence are health literacy, psychological issues, side effects of medications, and lack of support systems. There are also tens of millions of Americans who simply can’t afford medication. A survey by the Commonwealth Fund found that 48 million Americans did not fill a prescription in 2010 due to high medication costs.[i] The data show the negative health and economic effects of non-adherence to prescription medication. First, it’s been reported that 121,000 people die each year due to prescription non-adherence.[ii] Second, according to the FDA, non-adherence to prescription medication costs the country $290 billion annually in additional health care costs.[iii] Third, numerous studies have shown that cost is either the number one reason, or a major factor for non-adherence. [iv]
Access to safe and affordable medication should be encouraged through all available sources, including personal drug importation. Over the past 15 years millions of Americans have obtained needed prescription drugs through non-U.S. online pharmacies, despite its technical illegality. Currently, the U.S. Food and Drug Administration does not prosecute people for small quantities of personal drug imports.
The FDA discourages Americans from ordering from any non-U.S. online pharmacy, not because it’s illegal but for safety reasons. Its position is that the drugs ordered from Canadian and other foreign pharmacies are not regulated by the FDA, and are therefore unsafe. That position is simply unsubstantiated. Fortunately for people living in other countries there are other national regulatory authorities that regulate drugs to make sure they are safe and effective.
We’ve established that the problem of prescription medication adherence is so severe in large part due to high drug prices. If it is safe to order less expensive medication online that allows Americans to adhere to their doctor’s prescription then we should encourage their use. Are non-US online pharmacies safe?
The evidence shows that properly credentialed non-US online pharmacies which fill orders from licensed pharmacies, require a valid prescription, and provide verifiable contact information on their websites safely dispense genuine medication. The medication purchased for personal drug importation is often the same brand name product – from the same manufacturer – sold here but at a much lower price, often 80% less than U.S. pharmacies. A consumer is almost certain to receive proper care and safe medications from one that meets the aforementioned criteria and is certified in the PharmacyChecker.com Verification Program.[v] In fact, U.S. Government Accountability Office studies have shown the relative safety of Canadian online pharmacies compared to U.S. online pharmacies.[vi]
We recommend that the Secretary of Health and Human Services instruct the U.S. Food and Drug Administration to:
- Correct its website and consumer communications about online pharmacies to reflect the facts demonstrated by over a decade of studies and consumer experience. The FDA website should communicate that “if you decide to purchase medication online from Canada or another country then only use properly credentialed websites.”
- Explicitly allow, at least on a temporary basis, personal drug importation through properly credentialed non-US online pharmacies.
By taking these steps fewer Americans will go without needed prescription medication because it will be affordable. Moreover, more people taking prescribed medication will lead to fewer hospitalizations and emergency room visits, resulting in lower healthcare costs for the nation.
Sincerely,
Gabriel Levitt
Vice President
PharmacyChecker.com, LLC
[i] Commonwealth Fund:
http://www.commonwealthfund.org/Surveys/2011/Mar/2010-Biennial-Health-Insurance-Survey.aspx.
[ii] Cut Copayments to Bolster Adherence”, The Center for Medicine in the Public Interest, See http://www.cmpi.org/in-the-news/in-the-news/cut-drug-copayments-to-bolster-adherence/(last accessed July 27, 2011).
[iii] Campaign to Improve Poor Medication Adherence (U18), A Notice by the Food and Drug Administration on 03/09/2011, See http://www.federalregister.gov/articles/2011/03/09/2011-5287/campaign-to-improve-poor-medication-adherence-u18#p-13, (last accessed July 27, 2011).
[iv] For more information see: http://www.federalregister.gov/articles/2011/03/09/2011-5287/campaign-to-improve-poor-medication-adherence-u18; http://www.nclnet.org/images/PDF/adherence_focus_groups.pdf; http://www.hsph.harvard.edu/news/press-releases/2008-releases/poll-usa-today-kaiser-harvard-prescription-drugs.html (last accessed July 27, 2011)
[v] Bate, Roger, Ginger Zhe Jin and Aparna Mathur. “Unveiling the Mystery of Online Pharmacies: An Audit Studay”. National Bureau of Economic Research. Working Paper #17655 (http://www.nber.org/papers/w17955.pdf). April 2012.
[vi] U.S. Government Accountability Office. Some Internet Pharmacies Pose Safety Risks For Consumers, GAO-04-820. Washington, DC. Government Accountability Office June 2004. See http://www.gao.gov/new.items/d04820.pdf (last accessed June 26th, 2011).
by PharmacyChecker.com | May 24, 2012 | Drug Importation, Healthcare Reform, Online Pharmacies, Personal Drug Importation
McCain Amendment.
Senator John McCain (R-AZ) introduced an amendment to the Pharmaceutical Drug User Fee Act authorization bill that would create explicitly legal access to and facilitate safe and affordable medicine from Canadian pharmacies through a government list of online pharmacies. Sen. McCain should be applauded for continuing his efforts on this issue. Unfortunately, the amendment was voted down 43 to 54.
In his floor statements, predicting his amendment’s failure, Senator McCain communicated that too many of our elected representatives are beholden to the pharmaceutical industry. For that reason, we can expect future legislative actions to curb access to safe personal drug imports. Due to FDA’s current regulatory practices, Americans are not prevented from obtaining needed medications from verified international online pharmacies.
CBS News On Online Pharmacies and Drugs Safety
In a recent article, CBS News informs American consumers on critical issues of drug safety. When it comes to ordering prescription drugs online, especially from outside the United States, the article is clear that Americans should only shop from properly credentialed online pharmacies, such as those approved by PharmacyChecker.com.
Americans should take other precautions as well. For instance, you should only take prescription medications prescribed to you from your doctor. Check expiration dates to make sure your prescription product is still effective. Before taking medication, look at it closely for any indication something is not right, including disintegration or discoloration.
Online pharmacies discussed by world leaders at G8 summits
Leaders from the world’s most advanced economies discussed online pharmacies at the recent G8 conference. The topics discussed also included economic growth and development, food and nutrition, and international security. Global health experts criticized the G8’s agreement, as published in the Camp David Declaration, for an over-emphasis on intellectual property protection in its section that mentioned drug safety.
Americans who buy medication safely from properly credentialed international online pharmacies should be concerned about high level talks that address this issue. The pharmaceutical industry’s anti-consumerist positions on intellectual property rights are often overrepresented in such international organizations, and the industry seeks global action to shutdown safe international online pharmacies.
On the other hand, looking at the glass half-full, the Camp David Declaration makes clear that public safety – not intellectual property rights – are the goal in fighting rogue online pharmacies and counterfeit drugs: “To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products.”
We strongly support international actions to thwart the sale of dangerous medications online to protect both American and global patients. In fact, PharmacyChecker.com has been dedicated for almost a decade to evaluating online pharmacies in order to provide information about those that sell safe and affordable medication.
Tagged with: Camp David Declaration, CBS News, FDA, G8, John McCain, Pharmaceutical Drug USer Fee Act
by PharmacyChecker.com | May 16, 2012 | Counterfeit Drugs, Drug Importation, Online Pharmacy Verification Services, Pharmaceutical Industry
On May 14th, an article appeared in ForeignAffairs.com called “Dangerous Doses: Fighting Fraud In The Global Medicine Supply Chain.” Authors Tim Mackey, Bryan Liang, and Tom Cubic simultaneously report on the counterfeit drug threats and tragedies experienced globally while deceptively attempting to link safe international online pharmacies to this problem. Our vice president, Gabriel Levitt responded in Telling the whole truth about online pharmacies. His response is published below.
Telling the whole truth about international online pharmacies
Over a decade of experience and empirical studies [See “Unveiling the Mystery of Online Pharmacies: an Audit Study” in National Bureau of Economic Research] have shown that credentialed international online pharmacies sell safe and affordable medication, not counterfeit drugs, to Americans who otherwise might cut back or not take their medications at all. These credentialed websites work with licensed pharmacies that require a prescription and meet high safety standards for mail-order pharmacy. They just happen not to be located in the United States, which explains their low prices. They are not a part of the counterfeit drug threat but the authors of this article would like you to think that they are
So why do these authors take this position? Although not well disclosed, the two senior authors are directly affiliated with pharmaceutical corporate interests. Pharmaceutical companies in the U.S. do not want their sales undercut by lower cost imports of the same exact medicines they sell here because it negatively affects their profits. No one disputes this. Bryan Liang maintains a leadership position with the Partnership for Safe Medicines (PSM), which is largely funded by pharmaceutical companies and is currently led by the Deputy VP of Public Relations for the Pharmaceutical Researchers and Manufacturers of America (PhRMA). Thomas Cubic is head of the Pharmaceutical Security Institute (PSI), an organization of pharmaceutical company members. I believe the two entities share an office in Virginia.
The pharmaceutical industry has focused a lot of its lobbying muscle against drug importation laws that could help millions of Americans obtain needed medication. The pharmaceutical industry position is advocated on many levels through Liang’s Partnership for Safe Medicines and Cubic’s PSI, as well as through PhRMA and the National Association of Boards of Pharmacy with the goal of preventing non-US online pharmacies from selling to Americans even if they are safe. A careful reader would certainly find their position in this article.
The authors here accurately acknowledge that a majority of the world’s counterfeit drugs and the subsequent sickness and death they cause are found in countries with weak drug regulations and/or enforcement of laws. But they try and equate huge tragedies in developing countries where counterfeit drugs kill hundreds of thousands with the real but different dangers posed by the Internet.
Let’s just make one thing clear: The counterfeit drug problems found through online pharmacies in the rich countries are real but miniscule compared to the tragedies reported about in poorer countries. In fact, examples provided in this article perfectly reflect the sharp dichotomy in the numbers of counterfeit drug victims in the United States and in poorer countries. Eleven years ago one young American named Ryan Haight, 18, tragically died from an overdose of pills purchased online, which he should have never received. But it’s worth noting that the drug, Vicodin, was real – not counterfeit. In this case, the problem was dispensing medications without proper medical supervision – not counterfeit drugs. The people who sold him the Vicodin went to jail. In Niger, a much larger tragedy occurred – 2,500 people died out of 50,000 who were inoculated with bogus medication. Of course this had nothing to do with U.S. drug importation or online pharmacies. One might have expected the authors to mention the 238 Americans who died after ingesting fake Heparin, which was circulating thorough the legal U.S. drug supply in 2007 and 2008. This, too, had nothing to do with online pharmacies but exceeds in victims any reported incidents having to do with the Internet.
The authors would like you to believe that CanadaDrugs.com, a credentialed international online pharmacy, is a part of the counterfeit drug problem so as to foster actions that could block access to such sites. They state that one of its suppliers is responsible for the counterfeit Avastin in the United States. They fail to mention, however that the counterfeit Avastin had nothing to do with online pharmacies, safe or otherwise. As it happens, many pharmacies in the United States have at one time or another unintentionally sold counterfeit medication – including CVS and Walgreens, which is not a reason to shut them down.
The source of the most recent large scale problem with intentionally sold substandard medications distributed in the United States is in fact GlaxoSmithKline. They were fined $750 million for intentionally distributing millions of substandard pills all across the country. These products were manufactured at their facility in Puerto Rico. U.S. Marshalls confiscated $2 billion of products from the plant in 2005, the largest such seizure in history and worth at least four times the value of all drugs imported by Americans from Canada each year.
There is no doubt that companies and people operating websites that purposefully sell fake drugs or even real drugs without a prescription need to be shut down, and in many cases criminally prosecuted. Victims of bogus online pharmacies certainly go underreported and the problem is very serious. But it’s a different problem from the large scale counterfeit operations that are killing hundreds of thousands of people in poorer countries – a crisis that demands immediate action to prevent the next massacre. The UNDOC may in fact be a better venue for international enforcement efforts, as the authors point out, because police actions may exceed the WHO’s mandate. Interpol’s enforcement work in Operation Pangea definitely took out a lot of bad guys – more such efforts are needed. Certainly working in concert, tapping their respective strengths, UNDOC, Interpol, WHO-IMPACT can bring us to a better place where the counterfeit drug threat goes on the decline.
But when it comes to the American pharmaceutical market, we find 48 million Americans not filling a prescription each year due to cost – an underreported crisis from which many die. Some of these Americans seek affordable and genuine medication online from Canada and other countries to acquire needed medication.
To directly address the core of Foreign Affairs readers, we must not allow our foreign policy and multilateral actions to disadvantage American consumers who are struggling or can’t afford prescription medication. So as we ramp up our efforts to stop criminals from infesting the world with fake drugs let’s not enact policies that will block the access of Americans to life saving medications simply because it improves our corporate balance sheets.
Gabriel Levitt
Vice President
PharmacyChecker.com
President
United Nations Association Brooklyn Chapter
Tagged with: Bryan Liang, Counterfeit Drugs, Online Pharmacies, Online Pharmacy Verification Services, personal drug importation, Thomas Cubic
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | May 11, 2012 | Drug Importation, Drug Prices, FDA, Personal Drug Importation, Saving Money on Prescription Drugs
Americans need and deserve the freedom to buy medications that are safe and affordable. This is not only true as a matter of right and wrong; it’s a public health issue since about 48 million Americans don’t fill prescriptions due to cost. Online pharmacies offer an important outlet for affordable medication. That’s the good news. The bad news is that some Americans are forced to use online pharmacies when they would rather not; and others who need them are discouraged from doing so. What’s going on here?
According to a recent L.A. Times article, “Consumer Confidential: Fewer choices on buying medications,” more and more Americans are being forced by pharmacy benefit managers (PBMs) to purchase their medication through domestic online pharmacies. Traditionally, PBMs acted as middlemen between health insurance companies, drug companies, and pharmacies. The third party relationship between PBM and pharmacy is deteriorating and the online pharmacies being forced upon Americans are often owned and operated by the PBM! This stands in contrast to the international marketplace.
When it comes to buying medication from Canada and other international pharmacies, despite its technical illegality, Americans feel free to choose which online pharmacy they wish to shop from. We write “technically” because, due to its internal policy guidance on enforcement priorities, the FDA does not appear to prosecute individuals for buying foreign, non-controlled medication for their personal use. Still, the FDA discourages Americans from using all non-US online pharmacies, even safe ones.
Independent studies have shown that credentialed international online pharmacies can and do offer a safe shopping experience through which Americans can best afford their medication. This takes the wind out of the sails of safety-related arguments put forward by the pharmaceutical industry — which profits greatly from high American drug prices — against personal drug importation. But there are other criticisms of personal drug importation that have to do with economics.
Foreign pharmacies are cheaper because other governments negotiate with pharmaceutical companies to control drug prices for all their citizens, something the U.S. government does not do. Thus, personal drug importation is criticized for “importing” drug price controls and spoiling our “free market” in pharmaceuticals. But is our pharmaceutical market truly free?
In the LA Times article mentioned above, Jerry Lacy, who played Humphrey Bogart in “Play it Again Sam,” commented on his actor union’s arrangement with one of the largest PBM’s, Medco, which serves over 65 million people. “It’s like extortion…you do it their way or they won’t pay.” Mr. Lacy drew this conclusion after discovering he could only fill his prescriptions at the pharmacy of his choice twice at the insured (lower) price but then would have to buy from Medco’s online pharmacy or pay full (a higher) price elsewhere.
A letter to the editor by Chief Medical Officer of Express Scripts, another PBM, called “Letters: What Drugs Cost, and Why,” claims that PBM’s do provide choices. Well, maybe somewhat; but this is only partially true because the individual’s choice is not preserved. The employer or insurer chooses the option – not the individual. William Hale, in another letter to the LA Times editor, writes that he had to buy 90-day supplies for his medication from his PBM, even though his doctor would often change medication or dosage before the end of the 90 day supply. As a result, he has hundreds of unused pills and has ended up spending more than he would have if his PBM allowed him to purchase 30-day supplies from his local pharmacy. [For an excellent analysis about the free market for companies but not consumers read: “Inside The Secret World of Drug Company Rebates.”]
With foreign governments negotiating for lower prices in order to reign in government budgets, pharmaceutical companies seek higher profits from higher drug prices in the American “not-so-free” market..The American pharmaceutical market victimizes the millions of American consumers who are forced each year to pay more and more than their foreign counterparts for the same brand name medication or suffer the health consequences due to not taking prescribed medication. One way Americans seek justice is through international online pharmacies.
If considering online personal drug importation or any online pharmacy, experts have advised consumers to avoid online pharmacies that are not credentialed by reputable third parties, such as PharmacyChecker.com or VIPPS. But using common sense, Americans can and do make wise decisions about buying drugs online. For generic drugs, U.S. online pharmacies are often less expensive than non-US online pharmacies. The complete opposite is true for brand name drugs. Due to price competition among international online pharmacies (and of course foreign price controls), Americans can acquire from abroad the same medications sold here at an 80% discount.
By herding more of their members to their own pharmacies obviously PBMs can offer lower prices than local pharmacies; but this price reduction is not due to a “free market.” The only pharmaceutical market that is meaningful to most Americans is the one that provides them a safe prescription medication at the lowest price. Ironically it is often non-US online pharmacies that offer them such freedom.
Tagged with: Drug Prices, Jerry Lacy, L.A. Times, Online Pharmacies, PBMs
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | May 2, 2012 | Drug Importation, Drug Prices, Online Pharmacy Verification Services, Personal Drug Importation, Saving Money on Prescription Drugs
In their blog yesterday, our friends at RxRights.org, an advocacy group dedicated to helping Americans afford needed prescription medication, applauded Senator McCain’s (R-AZ) amendment to the Food and Drug Administration Safety and Innovation Act to greater facilitate safe and legal personal drug importation of prescription medications from verified Canadian pharmacies. Despite Senator McCain’s emphasis on verification and product authenticity, and co-sponsor Al Franken’s (D-MN) statement on this bill’s role in reducing overall healthcare spending, the amendment failed in a 12-9 vote in the Senate Committee on Health, Education, and Labor and Pensions.
Those against the bill cited drug product safety issues and concerns over the anonymity of the internet. Most vociferously, Senator Barbara Mikulski (D-MD) claimed that even with the bill consumers would still not know where there drugs were coming from, failing to recognize or understand that the solution to this problem is written in the amendment, which calls for a verification process that would identify safe online pharmacies. Just such a program was adopted by Kathleen Sebelius, now Secretary of the Department of Health and Human Services, when she was Governor of Kansas.
For more on this vote, please visit RxRights.org.
Click here for a video of the committee hearing. Coverage of the amendment begins at 28:40.
Tagged with: Al Franken, Drug Importation, John McCain, Online Pharmacies
