by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | Jun 6, 2014 | Drug Importation, Drug Prices, Generic drugs
Americans who take Celebrex to fight arthritis may be pleased to know that a generic version has been approved by the FDA. The New York Times’ coverage reports, in a somewhat predictive fashion, that generic drugs “can cost 30 to 80 percent less than the branded products.” While that’s true, don’t expect generic Celebrex to be so cheap. What’s most likely is that its price will initially be around 80%, and then creep downwards.
Millions of Americans have seen this pricing trend over the past few years, as many popular medications have recently gone generic. A patent’s expiry does not necessarily mean cheaper drugs, at least immediately. That’s because the FDA grants marketing exclusivity for a generic to a single drug company for six months, so only two drug companies – the brand name manufacturer and the first generic manufacturer – are competing. As more drug companies enter the market the price will eventually cost a fraction of the brand name counterpart. But that first generic to market will usually only be about 20% cheaper than the brand.
When atorvastatin (generic Lipitor) first came out you could actually save a lot of money by purchasing the brand from an international online pharmacy instead of the generic from a U.S. pharmacy. Now, with many companies manufacturing atorvastatin, generic Lipitor in the U.S. can be found for about $15 per month if you use a discount card. International online pharmacies that once had a leg up on U.S. pharmacies lose big once competition drives U.S. generic drug prices down.
A perfect example is the popular antidepressant Cymbalta. Currently, the cash price of a 90 day supply of duloxetine (generic Cymbalta, 60 mg) is around $250 – and that’s after using a discount card at the pharmacy. A 90 day supply of brand name Cymbalta is only $90 when ordered from an international online pharmacy – a 64% discount!
We expect this pricing pattern for Abilify, Gleevec, Crestor, and many other drugs coming off patent down the pipeline. In the initial phase of a new generic’s release, the brand version from an international online pharmacy will probably be much cheaper, but eventually your neighborhood pharmacy will be your best bet. So if you take Celebrex expect to celebrate a low cost U.S. generic in early 2015!
Tagged with: Atorvastatin, Celebrex, Cymbalta, Patent Cliff
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
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | Feb 13, 2014 | Drug Importation, FDA, Online Pharmacies
(Click here to skip the explanations and view the steps to finding a Canadian online pharmacy)
If you’ve seen one of the latest FDA press releases regarding Canadian pharmacies, you might be a little confused on how to find one. The FDA seems to acknowledge that there are legitimate – and therefore safe – Canadian pharmacies accessible online. Here’s what they say (with one word italicized by us):
“Don’t order medicines from web sites that claim to be Canadian pharmacies. Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.
Claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries. (Even if an online Canadian pharmacy is legitimate, in general, U.S. citizens cannot legally import prescription drugs from other countries. But that’s a separate issue. We’re talking here about fraud).”
The FDA’s focus on protecting you from online pharmacy fraud is commendable because that’s where the real health and safety threats reside. Since they don’t tell you how to find a legitimate, real Canadian pharmacy, we’re providing you with facts and guidance to help you make the right decisions for your health and prescription savings. Let’s remember, brand name medications sold in Canada and other non-U.S. pharmacies are often astronomically cheaper than ones here at home. (more…)
Tagged with: Canadian pharmacies, FDA, NABP, phrma
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 7, 2014 | Drug Importation, Drug Prices
Let’s give a big round of applause to CVS, the second largest chain pharmacy (behind Walgreens), for its decision to stop selling cigarettes and other tobacco products! To its credit, CVS is not being overly self-righteous, as it largely attributes the policy change as necessary to accommodate legal restrictions on tobacco sales in places where healthcare services are provided: this is in view of its plans to open up more healthcare clinics in its pharmacies throughout the country. So, come October, as per the company’s plans press release, Americans will no longer be able to buy cigarettes or other tobacco products at any of the 7,000-plus CVS stores nationwide.
Unfortunately, removing tobacco products from CVS’ shelves won’t help Americans afford their medicine. According to a survey by Consumer Reports, CVS has the highest drug prices (Costco had the lowest prices, especially on generics). While executives at U.S. pharmacy corporations have steadfastly opposed reforming drug importation laws to bring down drug costs, CVS’ former Chairman and CEO, Thomas Ryan, bravely supported it. To quote Mr. Ryan:
While many in our industry believe that importation is a fundamentally flawed concept and oppose it without exception, I have come to a slightly different view…Millions of Americans already have opted to import drugs because they can’t afford not to. We owe it to them to face this issue head on and not look the other way.
That statement was provided by Mr. Ryan in 2004. Since that time, access to affordable medication in the U.S. has only become more difficult due to higher drug prices, and Americans continue to personally import their medication, often from international online pharmacies.
The reason that those online pharmacies are a lifeline is provided by none other than…CVS! CVS/Caremark surveyed their pharmacists about a year ago; 61% cited high drug costs as the number one reason Americans don’t take their meds. Canadian and other foreign pharmacies have much lower prices and so Americans need them.
To be intellectually honest, Mr. Ryan’s idea was not for Americans to buy directly from Canadian or other foreign pharmacies but for CVS to import less expensive medication from verified foreign wholesale pharmacies and then sell it to Americans. Not a bad idea to help bring down drug costs, while keeping American pharmacists employed and corporate profits humming. Thus, understandably, Mr. Ryan’s position was dedicated to the public health and his business interests.
The heart and soul of Mr. Ryan’s position, however, is the public health alone – and not business interests. Once again, he said: “Millions of Americans already have opted to import drugs because they can’t afford not to. We owe it to them to face this issue head on and not look the other way.” They opt to import because brand name drugs are often 90% less expensive internationally. That’s why it’s best to help Americans safely buy medications where they can best afford it instead of looking the other way.
So you can put out that cigarette, get your flu shots from CVS, your generics from Costco and your brand name drugs overseas!
Tagged with: Consumer Reports, CVS, Tobacco
