by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 21, 2014 | Drug Importation, Drug Prices, Generic drugs, Personal Drug Importation, Politics
From Pembroke Consulting, published on DrugChannels.net
Yesterday, Senator Bernie Sanders (I-VT) held a hearing in front of the Senate Health, Education, Labor and Pensions Subcommittee on Primary Aging and Health entitled “Why Are Some Generic Drugs Skyrocketing in Price?” Bizarre drug price increases of 1,000% and up are becoming more common. This problem is not new: in the beginning of this year the People’s Pharmacy reported a 6,000% increase in the price Doxycycline!
Senator Sanders noted that the price of Digoxin, which treats congestive heart failure, has increased 883% from 12 cents to $1.06 per pill from 2013 to 2014. Migraine drug Divalproex Sodium ER spiked 881% from 27 cents to $2.38 per pill.
We are always ecstatic when Congress scrutinizes the obscene drug prices in America, and we applaud Sen. Sanders, but our focus is on what can be done now so that people today don’t go without needed medications. In his introductory remarks, Sen. Sanders said: “Drug prices in the country are by far the highest in the world.” Let’s elaborate on that. (more…)
Tagged with: Bernie Sanders, Digoxin, Divalproex Sodium ER, FDA, generic drugs, Pembroke Consulting
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 4, 2014 | Advocacy, Drug Prices, Politics
No matter how you vote today, or which party you like (if one at all), you may have ended up on this blog because you’re tired of high drug prices or struggling to afford medications you need. PharmacyChecker.com advocates for maximizing consumer-access to the lowest cost, safe and effective medications. We believe that it’s completely unacceptable and unnecessary for tens of millions of Americans to skip filling prescriptions each year because of cost. High drug prices in America are a public health crisis.
Access to affordable medication is a global public health priority and many people view it as a human right. According to the World Health Organization, ten million deaths could be prevented globally by improving access to safe and affordable medication. We strongly believe that much more can and should be done at the global level to help citizens of developing countries obtain life-saving medicines.
Our advocacy focus is – not surprisingly – “online access” to lower-cost medications, which requires an open and free Internet through which consumers can buy medication from safe international online pharmacies. We are a member of the RxRights.org coalition, which focusses on safe personal drug importation through verified international online pharmacies. We strongly encourage you to join them. They have a following of almost 85,000 Americans. Joining is free and for those of you activist-types it could be fun.
There are multinational pharmaceutical corporate forces aligned with willing politicians who accept their campaign contributions to prevent you from obtaining safe lower cost medications from outside the U.S. Pushing back and promoting online access to safe and affordable medication is not a liberal or conservative effort. It’s a big tent, non-partisan issue that draws consumers from all sides of the political fence who are tired of having to pay the world’s highest drug prices.
So, as long as you’re done voting, take this time to check out RxRights and stand up for more affordable medications!
Tagged with: advocate, election day 2014, RxRights
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 10, 2014 | Drug Importation, Online Pharmacies, Politics
In our recent public comments to the U.S. Food and Drug administration, we invoked your concerns with new FDA regulations to implement Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) for destroying safe (and affordable) medications imported for personal use. We issued a press release on the issue as well. Here are three of almost 2000 comments:
Morton Ross, Palm Harbor, FL 2014-04-03, “The Meds I take daily, are the difference between ‘Life and Death’. I cannot afford the higher prices at local pharmacies.”
Darilyn Schlie, Fort Worth, TX 2014-04-03, “Without the ability to go outside the US, I will not be able to afford the medication I need.”
James Marshall, Nashville, TN 2014-04-03, “I have emphysema and could not afford my medications if not for being able to order some of them from outside the USA.”
We need more voices! Working with RxRights.org, you can send a message to the Secretary of Health and Human Services stating your concerns, asking that she prevent morally unjust and dangerous refusals and destructions of imported drugs for personal use. The messaging process is easy and together we can win this!
The situation is not dire…yet. The regulation has not taken effect and it’s uncertain what its impact will actually be. Currently, the conventional wisdom holds that the chances of your prescription order being detained by U.S. Customs is less than 1%. What we don’t know is if the new regulations will change that dramatically.
What we do know is that FDA issued a proposed rule in May to implement Section 708, which is deceptively called “Destruction of Adulterated, Misbranded, or Counterfeit Drugs Offered for Import.” Destroying adulterated and counterfeit drugs sounds like a good plan but many, if not most, ‘misbranded drugs’ sold in foreign pharmacies are actually the same drugs you can buy at your local pharmacy just with different labeling and packaging. Though sometimes manufactured in a plant not registered with the FDA, they are manufactured in plants registered with another drug regulatory authority. Or they might be a generic version of a brand name drug that is approved in the U.S. but not yet off-patent here. These examples of real, safe and effective medications are usually deemed ‘misbranded’ or ‘unapproved’ by FDA. For more on this see my New York Times op-ed.
To Congress’ credit, before Section 708 goes into effect, regulations must be drafted requiring that consumers, 1) receive notification that their prescription drug orders have been refused import and 2) are provided “appropriate due process” to defend their drug imports before they are destroyed. Unfortunately, as I read it, FDA’s proposed rule did not assure consumers “appropriate” due process. In our comments we proposed that FDA clearly explain to consumers why their drug imports were refused and exactly how consumers can provide testimony to prevent the FDA from destroying their imported drugs. In the final rule, consumers should be able to successfully defend refused drug imports of safe and prescribed medication to have them released not destroyed. They need those medications to safeguard their health, and sometimes even lives.
We also proposed a revision to FDA’s personal drug importation policy so that safe personally imported medication from certain countries with very strong pharmaceutical regulations and pharmacy standards would not be detained or refused. We also recommended continuing actions to shutdown dangerous rouge pharmacy sites but not obtusely conflating them with safe international online pharmacies.
See below to learn more and advocate.
Petition the Government!
Comments by Americans concerned with Section 708
Comments by PharmacyChecker.com to the FDA on Section 708
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 2, 2014 | Advocacy, Personal Drug Importation, Politics
As we approach July 4th, a day to celebrate freedom in America, I urge you to stand up for your freedom to access safe and affordable medication!! Let’s face it: the global drug companies – big Pharma – would rather you pay higher prices for their medications because it makes them more money. In its infinite pandering to big Pharma, Congress included language in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) – an otherwise pretty useful drug safety bill – expanding the authority of the U.S. Food and Drug Administration to destroy safe, personally imported medications. In the spirit of independence – life, liberty, and the pursuit of happiness – take this time to send a message to the Secretary of the Department of Health and Human Services (HHS) asking that she take the necessary actions to protect your prescription drug orders, ones ordered from safe international online pharmacies.
Thanks to RxRights.org for leading the charge on this effort!
The onerous language under discussion is found in Section 708 of FDASIA, which allows the FDA to destroy medication orders valued at $2500 or less that are refused import. The medications subject to refusal and destruction are those deemed “adulterated, misbranded or counterfeit.” Those words seem pretty scary but don’t be fooled. Unlike an adulterated or counterfeit drug, an imported ‘misbranded’ drug can be the same, safe and effective medication sold in a U.S. pharmacy but with a slightly different label. Seizing and destroying a person’s safe prescription drug order is immoral, anti-American, and dangerous to that person’s health.
There’s a catch in the law, which actually invokes the Spirit of 1776. Before Section 708 goes into effect, the HHS Secretary shall draft proposed regulations to provide consumers with due process to “challenge the decision to destroy the drug.” That means Americans should have an opportunity when their medication orders are seized to tell the government “don’t destroy my safe prescription drug order.” As the agency under HHS tasked with regulating the nation’s drug supply, it’s the FDA that leads the government in this process. FDA’s proposed regulations, which are open for public comment, were drafted and published in early May. While they fail to provide what the law requires – “appropriate due process” – I believe they leave the door open to amend what they have proposed. This weekend I’ll be working to submit PharmacyChecker.com’s public comments to try and assist (persuade?) the FDA to issue a more consumer-friendly final regulation that protects your access to safe and affordable imported medication.
I invoke the spirits of our Founding Fathers to guide us in this fight for independence from the tyranny of high drug prices.
Happy Fourth of July!
Tagged with: Due Process, Regulations, RxRights, Section 708
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | Mar 28, 2014 | Personal Drug Importation, Politics
A couple of news articles from the state of Maine have me wondering if more Mainers are going to start importing medication from international online pharmacies. Maine is the only state that has, through the passage of a law, removed state restrictions on personal drug importation from pharmacies in a number of countries.
An article from the Sun Journal highlights a survey designed to track the impact of the Affordable Care Act in Maine (and perhaps these findings will apply to other states, too). Both low and middle-income Maine adults are struggling with medical bills. Surprisingly, 35% of middle-income adults had problems paying bills, compared to 32% of low-income adults. Budget cuts in the state have led to thousands of residents losing Medicaid coverage, so it is likely that the numbers will worsen for low-income adults.
Speaking of budget cuts, Maine Governor Paul LePage did not choose to expand another state program, Mainecare, which helps low-income residents pay healthcare providers. Samantha Edwards, writing for WLBZ, notes that residents who were in these programs are now looking elsewhere for assistance, especially for prescription drugs. The cuts to state programs are forcing municipalities to cover the costs. Rindy Folger, of Bangor Health and Community Services, said, “Since January 1st, we have seen over seventy-five people who we have never seen before who are now coming in looking for help with their medications…Monthly right now we are paying about $9,500 in prescriptions which, over the course of the year, is a significant amount of money for the Bangor taxpayers to have to pay.”
If municipalities like Bangor are going to be picking up the tab for medication, it might be wise for them (or the state) to implement prescription drug importation programs. Portland saved $200,000 a year on health care when it served prescriptions to its employees through PortlandMeds, a prescription drug importation program. It’s very possible – and reasonable – that more municipalities will implement these programs if the Maine’s healthcare cuts continue.
Tagged with: Maine, Obamacare, PortlandMeds
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Dec 31, 2013 | Advocacy, Online Pharmacies, Personal Drug Importation, Pharmaceutical Industry, Politics
This article summarizes good things and bad that are happening online with drug prices and savings, economics, legislation, politics, and even ethics that relate to access by Americans to more affordable medication offered by safe international online pharmacies. If you’re a consumer – especially an American consumer facing high drug costs – you should read this. When you’re done (or even right now!) we recommend joining RxRights to help play a role in making medication more affordable for all Americans.
Next year, we’re planning to focus more attention on local Americans pharmacies: what they’re doing right, wrong, and in between, and how you can save and take advantage of their in-store opportunities to improve your health! But for now, the international online pharmacy report…
The Good
The money Americans could save on brand name drugs by shopping at safe international online pharmacies continued to increase in 2013. In 2011 , we reported potential savings of 80%, then a mind-boggling 85% in 2012, and now 87.6% in 2013! Savings have proliferated because America’s trading partners, such as Australia, Canada, the states of the European Union, New Zealand, the United Kingdom, and Turkey, generally, have kept brand drug prices stable, whereas in America they increased by an estimated 13% last year.
The pricing data referred to above is from our prescription drug price savings research released this past September. In that report we looked at popular prescription drugs that are not always covered by health insurance plans, including new plans offered as a result of Obamacare. An extreme example of savings is on the drug Abilify 10 mg, a medication prescribed for depression; $9,007.08 could be saved annually by purchasing the drug from the lowest-cost online pharmacy verified by PharmacyChecker.com compared with a retail pharmacy in New York City. A more common example of potential annual savings from international pharmacies is the $3,935.28 savings on Spiriva Handihaler 18 mcg. Drug prices are out of control in the U.S., especially for those with no domestic generic alternative, and access to international online pharmacies is as urgent as ever.
It would, of course, be better if Americans could find more reasonable prices on brand name drugs at their local pharmacies.
(more…)
Tagged with: BeSafeRx, CSIP, FDA, ICANN, international online pharmacy, NABP, RxRights