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Hitting Pause on Criticism of the FDA, Just for Today

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is. I’ve also witnessed and participated in its criticism, and with good reason: the agency is not honest or forthcoming about personal drug importation; its drug approval process is “inherently biased”; due to the “revolving door,” the FDA is too cozy with Big Pharma; and many other things. Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration, much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics.  

Whily my advocacy initiatives implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. So, without further ado, a moment of praise amongst the criticism:

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Nexium OTC or Prescription Nexium: Singing the Generic Blues as Esomeprazole Magnesium Stays Purple

Last June we wrote about how Americans taking Nexium – AstraZeneca’s multibillion dollar proton pump inhibitor that treats gastro esophageal reflux disease (GERD) – were losing out on savings due to the FDA’s postponement of a generic version in the U.S. market. Well, it looks like they’re going to wait even longer to find generic copies of the Purple Pill at local pharmacies (and the generic versions probably won’t be purple!). Initially, Indian pharmaceutical company Ranbaxy held exclusive marketing approval to sell generic Nexium in the U.S., but they were banned from actually selling it due to poor manufacturing practices. Well, last week the FDA revoked both Ranbaxy’s approval and its marketing exclusivity for generic Nexium. That might be good for the Purple Pill’s profits (say it fast) – but it leaves consumers singing the blues.

Cash paying Americans are left with the following domestic options: Prescription-strength (40 mg), Nexium or Nexium OTC (20 mg). Prescription-strength Nexium will run you about $600 for 60 pills. That’s a ridiculous price. It’s only $70 to get 126 capsules of Nexium OTC! So, can you just buy Nexium OTC instead of prescription-strength Nexium and just take two pills?

You might be able to, but you need to ask your doctor, pharmacist, or other healthcare provider. I asked my local pharmacist if I could just take OTC Nexium instead, and without hesitation she said I could, but that it may not be as effective and that it comes as a tablet rather than a capsule. The OTC version also has different inactive ingredients, I was told, so if you are allergic to any of those, you should stick with the 40 mg version. She suggested OTC Nexium if I couldn’t make a trip to my doctor or if my insurance didn’t cover prescription Nexium. Even if Nexium is covered, it might be a tier 2 or 3 drug, which could result in your co-pay being higher than the OTC cost.

We’d feel remiss in not reminding you that there are a plethora of proton pump inhibitors on the U.S. market, many that come at a much lower price tag.

But if you need to stick with prescription-strength 40 mg Nexium, it is available from international online pharmacies: 60 pills would be about $50, so it’s actually a better deal than Nexium OTC in the U.S. It’s worth noting that just like the OTC 20 mg pill, the 40 mg purple pill is sold as a tablet, not a capsule, in many foreign markets. You can view our comparisons of Nexium prices.

Hopefully we see these delays sorted out, and a generic version of 40 mg Nexium finally come to market in America. Until then, Nexium OTC at your local drugstore or ordering from an international online pharmacy may be your best options to avoid the drug price blues.


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Consumers Lose Due to Postponed Generics for Nexium, Diovan, and Valcyte

Americans are used to finding low-cost generic medications about six months to a year after they’re approved by the FDA. Think Lipitor, Plavix and Lexapro, which are all priced about 80% lower as generics.

Unfortunately, patients who had been looking forward to newly-approved generic versions of Nexium, Diovan, or Valcyte will have to keep waiting as a knot of legal and regulatory guidelines delay their U.S. release. The FDA approved Indian drugmaker Ranbaxy’s generic versions of these meds but has banned the plants to be used for their production from exporting products to the U.S., due to findings of substandard manufacturing practices.

You’d think that another drug manufacturer could just make and market the drug, but the U.S. approval system doesn’t allow that. The FDA grants six months of exclusive marketing rights to the company that first gains approval for a generic drug. We wrote about this process two weeks ago in our blog post covering generic Celebrex. Even though Ranbaxy’s plants can’t export generic versions of Nexium, Diovan, and Valcyte to the U.S., it still retains marketing exclusivity in the U.S. market!

This is good news for brand name drug makers and bad news for consumers. Global sales for Nexium, Diovan, and Valcyte totaled $8 billion last year. Delays to generic Diovan have grossed Swedish drugmaker Novartis $100 million a month. Cash-paying Americans, as usual, are hurt most by these shenanigans as they continue to pay high prices for brand-name medication. Taxpayers should also be unhappy, since they are footing the bill for these brand name drugs purchased through programs like Medicare and Medicaid.

There is, however, a bit of good news on the horizon – the European Medicines Agency, an Agency under the European Union that evaluates medicinal products (like the FDA), will reinstate the good manufacturing practices certificate for Ranbaxy’s Toansa plant, which was slated to produce generic Nexium and Diovan. Hopefully, these improvements are good enough for the FDA.

In the meantime, so you’re not held hostage to drug price insanity, you can find these brand medications internationally at amazing discounts. Feel free to compare their prices:

Diovan – save 70%
Valcyte – save 70%
Nexium – save  93%

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