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 | May 29, 2014 | Advocacy, Online Pharmacies, Rogue Online Pharmacies
Each year, FDA participates in Pangea, a global operation that identifies and shuts down rogue Internet pharmacies, seizes allegedly dangerous medication, and arrests those responsible. We like that Pangea takes actions against rogue online pharmacies that threaten the public health. However, media stories about Pangea can frighten the American public away from safe online sources of affordable prescription medication because they often assert that foreign online pharmacies are all dangerous, which is absurd.
Thankfully, Dan Mangan of CNBC News reminded Americans last week that there are safe international online pharmacies. His article, “Patients cross borders for online deals on medication” explains that PharmacyChecker.com was created to help consumers avoid fake online pharmacies and have peace of mind when shopping for medication internationally. Lee Graczyk, head of RxRights.org, let them know why this is so important: “For some folks, this is the most viable way for them to fill their prescription at a price they can afford.”
The article points out that despite Federal restrictions, Americans purchase medication from outside the United States for personal use. Though the FDA does advise against personal drug importation (wrongly in our opinion), its enforcement is focused on large scale drug importation of medication by doctors, providers, or wholesalers, not individuals. In fact, FDA has never prosecuted anyone for importing medication for personal use. The article also brings up Maine’s recent law that removed state restrictions on personal drug importation. A similar bill was introduced in the South Carolina legislature.
Residents of these states want to facilitate drug importation to help people like Bill. As Mr. Mangan reports, Bill, a resident of New York City, was prescribed Copaxone for macular degeneration. Because Copaxone is not FDA-approved for that condition, Medicare didn’t cover it, leaving him with a ridiculously high out-of-pocket cost. At the suggestion of his doctor, Bill used a Canadian pharmacy. Instead of paying about $5,000 for a 28-day supply, he paid $1,200.
We’re happy with Mr. Mangan’s reporting, as coverage of crackdowns against dangerous pharmacy websites should include balanced information. His coverage included information collected from both supporters for and against personal drug importation and international online pharmacies, and he should be applauded for doing so.
Tagged with: CNBC, FDA, Operation Pangea
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | May 16, 2014 | Advocacy, Drug Prices
AIDS prevention may be revolutionized if healthcare providers start to write more prescriptions for Truvada as a preventative measure for people at high risk for contracting HIV. As reported in the The New York Times, the U.S. Centers for Disease Control and Prevention is pushing for expanded use of Truvada as a prophylactic to prevent new HIV cases. To date, it has been primarily used to treat people who have already contracted HIV. If this recommendation is adopted, the number of prescriptions written for Truvada could increase from less than 10,000 per year to 500,000 per year, hopefully lowering the rate of new HIV infections, which has remained steady at 50,000 per year over the past decade.
But what if patients can’t access Truvada because of its cost? After all, a drug doesn’t work if a patient can’t afford to take it. The drug has a monthly cash price of about $1,500 at local U.S. pharmacies. Fortunately, Truvada is usually covered by insurance and Gilead offers an assistance program that covers the first $200 of a co-pay. They also have a program that covers the full cost of the drug for eligible uninsured or underinsured patients. Eligibility is not guaranteed to all!
Even if you’re insured and prescribed Truvada, the high cost might mean difficulties when it comes time to fill the prescription. Many pharmacy benefit formularies put the drug in tier 2 or 3, which means high co-pays. Other formularies place Truvada on a list of drugs that require pre-certification. In that case, the drug might not even be covered at all!
According to FiercePharma, dramatic increases in the number of prescriptions written for Truvada (and therefore requests for pharmacy benefit reimbursements) could increase co-pays and also curtail assistance programs. If that happens, patients may find themselves having to fork over a lot of cash for higher copays, deductibles or co-insurance. Some may very well end up stuck with a $1,500 per month bill.
For these patients, or anyone else who falls through the cracks, international online pharmacies may be an option. Truvada – the brand – is available for about $543.00 internationally; the generic – emtricitabine/tenofovir – not yet available in U.S. pharmacies, is $224.00. This could provide a lifeline for Americans who are prescribed Truvada in the coming years.
Tagged with: AIDS, CDC, Gilead Sciences, HIV, Truvada
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | May 9, 2014 | Advocacy, Drug Importation
I penned an op-ed for the Bangor Daily News’ weekend edition called “Maine’s Drug Importation Law Does not Endorse Online Pharmacies. Should it?” Maine passed a good law last year, lifting the state’s ban on personal prescription drug imports from pharmacies in Australia, Canada, New Zealand, and the United Kingdom. U.S. pharmacists and drug companies want Mainers to believe lifting the ban is not safe even though it is. But is it safe to order medications online from India and even island nations? It can be. In my piece, I examine the issues, which are not black and white and therefore merit an open and honest discussion. It also clarifies the differences between dangerous rogue pharmacy sites that are bad for consumers and safe international ones that help Americans afford prescribed medication.
For those interested in knowing more about this issue please read the International Online Pharmacy Report.
Tagged with: Bangor Daily News, Maine
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 25, 2014 | Advocacy, Drug Importation, Drug Safety
While it’s a life (and wallet) saver for millions of Americans, it seems to me that safe personal drug importation is an inconvenient truth for the U.S. Food and Drug Administration. A couple of weeks ago, The New York Times published a Letter to the Editor, “Unsafe Foreign Drugs,” by FDA Deputy Commissioner Howard Sklamberg as a response to my op-ed. His letter didn’t refute the gist of my position: the FDA and other regulators should not scare Americans or fool policymakers into believing that genuine medications purchased by Americans from licensed pharmacies in Canada and other countries are as dangerous as counterfeit drugs.
Mr. Sklamberg wrote, “Gabriel Levitt criticizes the Food and Drug Administration’s position that unapproved foreign drugs pose the same health risks as counterfeit drugs.” In fact, I do more than criticize FDA’s position. Their position is false and illogical. When FDA talks about “foreign unapproved drugs,” it often means real medication available in foreign pharmacies. That medication is either exactly the same as the medication sold here or a foreign version with the same active ingredients as medication sold here. When FDA talks about “counterfeit drugs,” they generally mean fake medication: products sold by criminals that fool people into believing that they were manufactured legally. In other words, it’s medication not licensed for sale in any country because the manufacturers – “counterfeiters” – were not authorized by any regulatory authority to make the drug. Real medication that is made under good manufactured practices and properly prescribed to a patient is almost always safe and effective. Fake (counterfeit) medication is almost never safe. For those reasons, claiming that drugs sold from pharmacies in other countries are as dangerous as counterfeit drugs is ridiculous.
Mr. Sklamberg cites the National Association of Boards of Pharmacy’s (NABP) data that only “3 percent of online pharmacies appear to meet state and federal laws” to show that most drug-selling websites are dangerous. What he doesn’t tell you is that the 97% of online pharmacies which fall outside this scope includes safe pharmacies, for example, licensed Canadian pharmacies in Manitoba that sell to Americans – in conformity with all Canada’s laws and rules. The NABP considers these “rogue” online pharmacies. Since the NABP represents U.S. boards of pharmacy, which are in turn heavily self-regulated by U.S. pharmacy interests, referring to all lower cost non-U.S. online pharmacies that sell to Americans as “rogue” appears commercially motivated. Furthermore, NABP takes considerable funding from drug companies for programs related to Internet pharmacy regulation and consumer communications, which also casts doubt on their independence.
Mr. Sklamberg writes: “Many sellers of unapproved foreign drugs falsely represent that they are from Canada to give the illusion that consumers are getting the same drugs approved for use in Canada.” That’s true; it is a problem, but that doesn’t mean there aren’t exceedingly safe non-U.S. online pharmacies. As we’ve explained on this blog, there are reputable Canadian pharmacies that have partnered with licensed pharmacies in other countries. Compare that to fake “Canadian” online pharmacies that publish the maple leaf and wave the Canadian flag. These are unethical, unsafe, and unrepentant operators often located in Russia and Eastern Europe. The NABP conflates the two kinds of websites, strikingly similar to FDA’s conflation of foreign, but “real,” medications with counterfeit drugs. If you want to find ones selling real medication, pursuant to a real prescription, dispensed by real licensed pharmacists, look for PharmacyChecker.com verified online pharmacies at http://www.pharmacychecker.com/online-pharmacy-ratings.asp.
What consumers want and need is real information on which online pharmacies sell genuine prescription drugs, dispensed safely by licensed pharmacists, for the lowest prices. That’s why Americans who choose to order outside the U.S. benefit from the information provided by PharmacyChecker.com.
To his defense, Mr. Sklamberg is an employee of the FDA and therefore is in the service of a bad law that restricts Americans from buying lower cost medications internationally. Hopefully he decides the best course for the public health is to encourage his agency to use its regulatory discretion to expand access to affordable medication internationally. FDA has considerable regulatory flexibility to do so.
And perhaps FDA is listening. My op-ed cited a particularly concerning provision of U.S. law, Section 708 of the Food and Drug Safety and Innovation Act, which facilitates the ability of regulators to destroy personally imported medication. Section 708 cannot go into effect until regulations are drafted and available for public comment on the due process provided to Americans whose medication orders are seized. The FDA’s website identifies April 18th as the date it planned to publish the regulations, and that date has come and gone with no sign of their publication!
Maybe the FDA’s delay is due to the 8,000+ Americans who petitioned them to make sure those regulations don’t impede their access to prescribed medications. I’ll leave you with a few comments posted to that petition explaining why Americans depend on safe personal drug importation and should have access to it:
CT Robertsson Jr — DENTON, TX
I am 72 yrs old, take several medications, and am likely to need others in the future. The price for some of my current drugs is criminal. Americans should cease being the personal property of drug companies who have billions to spend on political influence. If we’re all about “freedom” and “competition”, then let’s act like it.
Barbara Simpson — MCKINNEY, TX
I cannot afford my medications at the price American Pharmacies charge. If I am unable to obtain them from Canada at a much lower price it will mean I will have to go without my medications.
Ellen Renee Dill — SMYRNA, GA
I am on a fixed income. My insurance doesn’t cover every drug prescribed.
Michael Catalanello — PONCHATOULA, LA
It’s a freedom issue.
Tagged with: Howard Sklamberg, NABP, New York Times
by PharmacyChecker.com | Apr 8, 2014 | Advocacy, Drug Importation, FDA
Americans may be concerned by recent reports in the media about the safety of medications made in India (e.g., the New York Times article “Medicines in India Set off Safety Worries”). Problems with Indian drugs should be neither overlooked nor overstated. In this post we try to put this into perspective for American consumers who purchase Indian medication at their local pharmacies, whether they are aware it’s from India or not, or directly from an Indian pharmacy by ordering online.
Over the past decade, prescription medicine made in India has been sold in large quantities in U.S. pharmacies. Today, according to the FDA, Indian medications make up about 33% of all prescriptions filled here. In fact, Walmart’s ability to offer a $4 generic drug program was initially due to importing and selling medicines from the Indian drug companies Ranbaxy and Cipla. However, last year Ranbaxy was found to be making false claims to the U.S. Food and Drug Administration and exporting medications to the United States that did not comply with FDA’s regulations. The FDA fined Ranbaxy $500 million and banned importation of its products made in India.
It’s important to note that well-known brand name pharmaceutical companies, based in the U.S. and other rich countries, also have serious manufacturing problems. GlaxoSmithKline was fined $750 million for knowingly selling adulterated prescription medication that ended up in local U.S. pharmacies. In 2010, Eli Lilly was sent a warning letter from the FDA for violations of good manufacturing practices. Those are two examples of many.
The FDA’s discovery of more problems at Indian manufacturing plants is not necessarily due to new health risks associated with Indian drugs. In the past, the FDA could not afford to conduct regular inspections of many, if not most, foreign drug manufacturing facilities. Greater funding under a new law has enabled more FDA scrutiny of Indian drug companies, which has led to increasing regulatory enforcement by FDA. A major problem is that the Indian counterpart to the FDA, the Central Drug Standard Control Organization, needs to do a better job regulating drug safety. In fact, FDA Commissioner Margaret Hamburg recently travelled to India to engage her counterparts in a plan to improve regulatory oversight of drug manufacturers. We applaud her initiatives with India.
Another issue in India is that some Indian manufacturers make less quality, lower cost medicines for sale to poorer countries and to poorer segments of the population within India. This two-tier system is sad but true.
So where does that leave you as a consumer?
Notwithstanding the greater scrutiny by FDA in India, Indian medications sold to Americans are generally of high quality, whether purchased at a U.S. pharmacy or from a PharmacyChecker-approved online pharmacy dispensing from India. To be approved within the PharmacyChecker.com program, an Indian pharmacy must only dispense medications manufactured in plants which are 1) approved by FDA or by other strong regulatory authorities such as those in Canada and the UK; 2) operated by the largest and best Indian drug manufacturers who are known to most consistently sell high quality medication; or 3) approved by Indian regulators and inspected by qualified American personnel to meet FDA standards of Good Manufacturing Practices. In addition, every Indian pharmacy approved by PharmacyChecker.com has been inspected by an American pharmacist with special expertise in international mail-order pharmacy safety, and its pharmacy license has been verified with regulatory authorities in India.
As we’ve written before, international online pharmacies are not just “Canadian pharmacies.” Most of the reputable ones originated in Canada but are now partnered with pharmacies in several countries, including India. Other verified and safe international pharmacies are located in Australia, New Zealand, and the United Kingdom. There are even pharmacies created specifically for international mail-order pharmacy services on island nations. The ones approved in the PharmacyChecker.com Verification Program meet very high standards.
Where you order from should be based on the best information available and we strive to provide it. India has become the top supplier of generic medications worldwide but not all their medications are created equal.
Tagged with: Cipla, Eli Lilly, FDA, GlaxoSmithKline, India, Indian Pharmaceuticals, Ranbaxy
