FDA Tells Novartis That 'Facebook Sharing' Widget On Its Site Violates Drug Ad Rules

from the sharing-is-not-caring dept

Technology can certainly make for some interesting clashes with regulatory regimes. Social networking, for example, starts to bring up all sorts of questions about the fine line between certain regulated areas of advertising, and basic free speech communication issues. Eric Goldman points us to the news that the FDA is warning pharma giant Novartis (pdf) over its use of a "Facebook Share" widget on its site promoting the drug Tasigna (a leukemia drug). The specific complaint is that the "share" feature includes promotional material about Tasigna, but not all of the associated risks (and, as with so many drugs, there's quite a list of risks). Because of the limited amount of space often used in "sharing" content, the FDA feels that some of the sharing options are misleading, not correctly noting that the drug is only approved for some users.

The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products. Thus, the shared content for Tasigna misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations.

The FDA even picks on the specific word choices in some of the sharing features, such as calling the drug a "next-generation" drug, which apparently implies it's better than other drugs in the space when that might not be the case. Advertising and marketing for pharmaceuticals has always been a contentious area, and I believe that many countries ban it, while the US allows it. But with the internet and social networking, the line between advertising and communication can start to blur. Yes, it may be problematic if Novartis is suggesting people "share" misleading or incomplete info about the drug, but what if people just start sharing that info on their own? Where do you draw the line?

Filed Under: communications, regulations, sharing, social media
Companies: facebook, fda, novartis

Pfizer, Novartis & Eli Lilly Received A Bunch Of Illegal Pharma Patents In India

from the jacking-up-the-price-on-known-medicines dept

As you may or may not know, India only recently changed its patent laws (under sever pressure from foreign countries and pharmaceutical companies) to allow pharmaceutical patents. Before that, pharmaceuticals (for the most part) were unpatentable there. Of course, contrary to what patent system supporters would tell you, India had a thriving pharma industry. Yes, a lot of it was in generic drugs, but according to patent system supporters if people can just copy each other, no one will even bother to get into that business. Reality shows that wasn't true. But, of course, the big pharma companies were quite upset by all of this, and got their governments to put pressure on India to "join the world community." In 2005, India's new patent laws went into effect, and while the results of all of this are still being analyzed, one thing that politicians smartly put into the law were sections 3(d) and (e), "which restrict protection being granted to already known and long-ago patented drugs and their combinations." This upset pharma industry sympathisers, but it's hard to fathom who could reasonably be against such a rule. You simply should not be able to patent things that are already known or patent the simple combinations of drugs that are already known. This is just common sense to prevent pharmaceutical firms from getting monopolies on drugs already out there.

However, Jamie Love points us to the news of a new report that found that the Indian patent office has gone against this law and issued such patents quite frequently and, no surprise, the main recipients are among the world's largest pharma companies, including Pfizer, Novartis and Eli Lilly. Is it any wonder that they've all been pushing to dump sections 3(d) and (e) all along? Remember, pharma patents are not about drug discovery, but about jacking up the prices on drugs.

Filed Under: india, patents, pharma
Companies: eli lilly, novartis, pfizer

India Won't Patent Minor Modifications In Drugs

from the closing-the-loophole dept

While many people are aware of how dangerous software patents are to innovation in the software space, not nearly as many feel the same way about pharmaceutical patents. However, there is increasing evidence that pharmaceutical patents are harming healthcare in a variety of ways, often by slowing the pace of innovation by locking up important concepts and making them too expensive. Recently, India was pressured to update its patent system to cover pharmaceuticals (in many countries, pharma patents are a relatively recent addition), though the rules state that drugs created before 1995 cannot receive patent protection. However, drug makers have long learned that a great way to artificially extend patent protection on a drug is to make a tiny modification and then get a new patent. That's why you now see Clarinex on the market from the maker of Claritin. Claritin went off patent, so the maker came out with Clarinex, advertising that it was much better, even though that doesn't actually seem to be the case.

It seems that pharma firm Novartis tried to use this little trick to sneak in patent protection in India for a leukemia drug that came out before 1995. It tried to get a patent on a slightly modified version of the drug, which would then let it ban the sale of generic versions of the non-patented version of the drug. Luckily, as pointed out at Against Monopoly, an Indian court has denied the request, since Indian law says patents should only be granted for new products, or ones where there's a significant improvement -- which is not at all true in this case. That means generic makers can continue to market their drug in India and many, many more leukemia patients will be able to afford the medicine. Novartis, of course, whines that this will slow down drug development, but the evidence suggests exactly the opposite. Having a truly competitive market increases the incentive for real innovation. What Novartis wants is to focus on marginal, useless innovation for the sake of keeping monopoly profits.

Filed Under: patents, pharmaceuticals
Companies: novartis