OxyContin(ues)- The FDA gets it right

The age-old debate about pharmaceutical patents, novelty, and money will probably never end.

While some people want to abolish pharmaceutical patents altogether (and good luck ever seeing a new drug again), most other pharma critics are at least somewhat rational. Yet, many still maintain that drug companies overuse patent protection as a tool to maximize profits, while providing no real innovation.

The first opinion is, of course nonsense--without patents to protect their inventions, no drug company in its right mind would spend a billion dollars to develop something that other companies (that incurred none of these costs) could sell for a fraction of the price.

And although the second opinion is frequently misguided--this is not always so.

There is a gray area where the concepts of novelty and advantage are blurry and can be open to a wide range of interpretation-- issues that are frequently fought in court.

Operating within this gray area are line extensions and "copycat" drugs--those with just enough difference to get a patent, while providing little or no real benefit to patients (Prilosec vs. Nexium is probably the best example of this). Additionally, new patents can be obtained for older drugs by simply tweaking the formulation, which may offer an advantage (sometimes small) relative to the old pill. It is this type of case where criticism is the most persuasive.

It is hard to argue with this. As I wrote here earlier this month, I believe that there are egregious cases where patents are granted to drugs or formulation changes that have questionable value, are used solely as line extensions for drugs that will otherwise lose patent protection. Economics over science.

But these are the exception, not the rule. Most patents are for new drugs, or new uses for older drugs. They are legitimate and necessary.

Every so often, an old drug can become quite innovative, simply by significantly changing a formulation, and the difference in properties can be profound.

Purdue Pharma, the makers of OxyContin did just that.

OxyContin is a very important drug for treatment of serious chronic pain. It is a time-release formulation of oxycodone (the narcotic in Percocet) but contains a much larger amount of the drug, which is gradually released providing prolonged pain relief and (at least theoretically) a lower addiction potential. Also, the time-release formula was designed to make the drug less prone to abuse (although users got around this).

Purdue persevered, and it paid off. But choosing a very clever formulation, they managed to make OxyContin so abuse-proof that abusers could no longer crush up the pill and smoke it. This worked so well that frustrated narcotic addicts quickly switched to heroin instead. These unintended consequences will undoubtedly not be lost on fans of irony.

So in this case, common sense by the FDA-- often two mutually exclusive terms-- prevailed, and because of this, other companies are banned from selling their generic version of OxyContin. Which I think is perfectly fair, considering what Purdue was able to accomplish after years of formulation research.

The FDA hit the potential generic competitors with a double whammy. The agency announced that it would not approve any generic versions of OxyContin. Additionally, they also approved new label for the reformulated OxyContin, based on the "tablets' physical and chemical properties make them more difficult to crush, meaning that abuse is less likely than with the original."

Good for them.

Purdue worked long and hard to solve some really difficult problems. They have earned the right to profit from their work.

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