by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jan 23, 2015 | Counterfeit Drugs, Drug Safety
FDA Seized Counterfeit Cialis at International Mail Facility
The FDA issued a warning about counterfeit Cialis, an erectile dysfunction (ED) medication, being sold through the mail, which probably means it was purchased from a rogue online pharmacy. The fake Cialis is some whacky combination of Cialis’s active ingredient, tadalafil, and the active ingredient in Pfizer’s Viagra, called sildenafil. Apparently, the FDA seized the counterfeit product before it reached a consumer in the U.S. by mail.
Fortunately, over 99% of safe, personally imported prescription drugs are not seized at international mail facilities. Still, I’ve given the FDA considerable grief about seizing safe medications, which they usually deem “misbranded” or “unapproved” for intellectual property or labeling reasons – but in this case FDA protected someone from a bad drug and that’s cool.
According to Reuters, FDA “cautioned against purchasing prescription medicines online, noting that some websites may be selling unsafe products.” The FDA also said that there is no indication that the “legitimate supply chain” – meaning the U.S. domestic supply chain – is at risk and that licensed U.S. pharmacies are safe. That’s probably true but there’s no reason to believe that the legitimate supply chains in other countries aren’t safe either. In other words, foreign online pharmacies verified by PharmacyChecker.com continue to sell real Cialis, the one marketed by Eli Lilly, for a lot less than they do here. The lowest cost Cialis (10mg) is $14.25 at a PharmacyChecker.com-approved international online pharmacy. That compares with a whopping $44.92 per pill at a one of the lower cost VIPPS-approved online pharmacies (VIPPS is the online pharmacy verification program of the National Association of Boards of Pharmacy).
The FDA recommends that consumers do not take Cialis supplied in bottles matching one or more of the following descriptions:
- lists “AUSTR81137” on the front of the bottle;
- does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
- does not include the tablet strength in a colored box;
- has different patterns and colors; it has yellow and darker green designs on the front label;
- has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle;
- lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
- lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.
I don’t agree with one of these – the bolded one – and here’s why: safe and real Cialis, or other genuine medications, ordered from online pharmacies won’t necessarily have an NDC number on it. In fact, if you were to travel to another country and purchase meds, real prescription drugs, in a brick-and-mortar pharmacy, they would not have an NDC number. That’s because NDC is unique to drugs packaged for sale in American pharmacies. Other countries use different labeling systems; for example, Canada’s version of NDC is called DIN (drug identification number).
One last important note: the truth is that many people want to get ED meds online, whether it’s Viagra, Cialis, or Levitra, without a prescription. PharmacyChecker.com strongly recommends that you don’t do that. The studies show that online pharmacies that don’t require a valid prescription are more likely to sell fake or otherwise bad medication, especially bogus ED meds!
Tagged with: cialis, Eli Lilly, Pfizer, Viagra
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 PharmacyChecker.com | Aug 14, 2013 | Drug Importation, Drug Prices, Online Pharmacies
A weekly series identifying prescription drugs manufactured in America and their prices.
Strattera (Atomoxetine HCl) is a popular attention deficit hyperactivity disorder medication for use by children and adults. Strattera, an Eli Lilly product, is manufactured right here in the U.S.A., but is far more expensive in American pharmacies than elsewhere. In fact, the price difference is shocking – 90 capsules (25 mg) will run you $828 at a Rite-Aid in New York City; from a verified international pharmacy it only costs $310.50. That’s a 63% savings, or just under $2,100 over the course of a year.
Check back next week for the savings on another American drug available abroad.
Tagged with: ADHD, American Made Prescriptions Are Cheaper Abroad, Eli Lilly, Strattera
