Pharma Companies Try 'DRM' For Drugs As A Ploy To Stymie Generics

from the just-can't-give-it-up dept

One of the striking features of the drug world is how pharma companies become noticeably more inventive immediately before their patents are due to run out and their drugs are about to enter the public domain. That's because they need to find a way to differentiate themselves from the generic manufacturers that are then able to offer the same medicines for often vastly lower prices.

Usually this takes the form of modifying the formula of a drug slightly, patenting it, and then seeking to convince the medical profession that the new formulation is better in some way. But sometimes it involves more novel approaches, as here: In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.



But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills' narcotic payloads. As the New York Times article quoted above reports, having introduced these "tamper-resistant" designs, the pharma companies are now pushing to get a ban on generic versions that lack this feature. If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.

The drug companies have dressed this up as a service to society, but some aren't buying it: While companies like Purdue Pharma insist the public's health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection. In court papers filed in response to Endo’s lawsuit, the F.D.A. described the company's action as a "thinly veiled attempt to maintain its market share and block generic competition." There's no doubt that the abuse of painkillers is a significant problem, but according to another recent story, in The Washington Post, alarming levels of addiction to OxyContin and similar painkillers may be partly the drug companies' fault. For instead of warning doctors about this issue, the latter were assured that there were "minimal risks of addiction and dependence" if they prescribed these kinds of drugs for their patients: according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims [about minimal risks] were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers. So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

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Filed Under: drm, drugs, generics, pharmaceuticals

Companies: endo pharmaceuticals, purdue pharma