Why do pharmaceuticals switch prescription drugs to over-the-counter?

The Prescription Access Litigation project has a wealth of information about the pharmaceutical industry.  Here's their answer to the above question. 

There are a number of reasons. Since it’s easier for a patient to get an OTC drug (you don’t have to visit the doctor and get a prescription), it’s likely that more people will buy it. So switching a drug to OTC can increase a company’s sales. Many people also have the impression that Over-the-Counter drugs are “safer” than prescription drugs, even though this is not necessarily the case. So switching a drug from prescription to OTC can convince people who might worry about the drug’s safety to buy it.

But sometimes drug companies make this switch as part of a larger strategy to protect and increase their profits. This usually happens when a prescription drug’s patent is about to expire. A company that discovers a new drug gets a patent that prohibits anyone else from selling that drug for a certain number of years. When that patent expires, the company’s profits on that drug drop, as competitors start selling generic versions of it. Brand-name drug companies have used a variety of questionable schemes to protect their sales when this happens. Sometimes they introduce an “extended release” version of the drug (that lasts, say, 12 hours instead of 6); or they introduce a “new” brand-name drug that’s really a minor tweak of the old drug.

Sometimes, as part of this, the brand-name drug company will try to get the FDA to switch the drug from prescription-only to Over-the-Counter. When Prilosec’s patent expired, the manufacturer petitioned the FDA to make it over the counter, while at the same time introducing a “new” prescription drug, Nexium. Claritin’s manufacturer did the same thing when its patent expired, while introducing Clarinex, a “new” prescription allergy drug.

Making this switch has a couple of effects:

• It can hurt the sales of the generic versions of the prescription drug, since it’s easier for consumers to just buy the OTC drug than go to the doctor and get a prescription. There are already numerous obstacles to generic drug companies making cheaper prescription generics available to consumers. This tactic just adds to those obstacles, potentially hurting consumers in the long run as fewer generics come onto the market.
• Health plans usually will not cover the OTC version, but often will cover the “new” brand-name prescription drug. Health plan co-payments for drugs are often lower than even the cost of the OTC drug, meaning that it’s often actually cheaper for the consumer to pay the co-payment for an expensive brand-name prescription drug than the full-price of the OTC version. But the overall cost to the health care system, and thus to all of us, is higher because of the higher price of the brand-name prescription drug.
• The manufacturer usually starts a splashy advertising campaign to convince consumers that the “new” drug is a major breakthrough that makes it worth the high pricetag. They may also run ads for the OTC version. When Nexium came on to the market, AstraZeneca spent huge amounts on ads focusing on its treatment for “gastric reflux disease,” a serious sounding disease, while ads for Prilosec OTC (essentially the same drug) focused on heartburn, a reasonably-harmless sounding symptom.
• If the company does new studies (clinical trials) as part of its request to the FDA to allow the switch, it gets to be the only OTC version on the market for three years. It can then aggressively market the OTC version and preserve a good-size chunk of its profits on the drug.

Source: Prescription Access Litigation (PAL) Project

When you hear about the high cost of medical insurance, remember this article.

Technorati tags: pharmaceuticals, prescription drugs, generic drugs

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[Prescription Access Litigation]

Thanks for reposting our latest "Ask Pharmie" column! This edition of "Ask Pharmie" (www.askpharmie.org) was a foreshadowing of the Bitter Pill Award we announced yesterday -- we gave GlaxoSmithKline the ‘With Allies Like This, Who Needs Enemas?’ Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter.

The award was for GSK's launch of "alli," an Over-the-Counter version of orlistat, a weight loss drug previously only available by prescription (and called Xenical). The drug has some rather disgusting side effects and is not appropriate to be made Over-the-Counter. Read all about the award at prescriptionaccess.org/blog/

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[birth injury attorney]

It is important to always keep in mind that pharmaceutical companies always need to focus on profit. The incentive is always for them to choose the strategy that keeps profits increasing. For certain drugs that means changing to over-the-counter status. For other drugs, such as the types of drugs used in cancer treatments and the kinds of drugs that have severe side effects going over-the-counter is simply not an available option.

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