Delaying generics through "citizen petitions"
I saw this a few days ago in the WaPo — which is quickly becoming a favorite news site of mine, due to real, original reporting — and it's another straw on the camel's back, so-to-speak. I find myself defending Big Pharma quite a bit; I feel they're given an unfairly bad rap most of the time. Perhaps because they're easy targets, I'm not sure. But then you read stories like this that make you ready to throw in the towel and write the lot of them off as nothing but greedy money-grubbers.
On the one hand, you've got rules that work in your favor for a certain amount of time in the form of patent protection. They protect your intellectual investments so you can recoup costs and make money. I don't know of a single person that would begrudge anyone this. Without the profit incentive, why innovate? It didn't work particularly well in Soviet Russia, and it doesn't work well today, either. Carrots work better than sticks when it comes to creating and innovating.
On the other hand, you wonder why one of the parties has to be a spoil-sport and ruin the party by trying to bend the rules to their further benefit. Given that any single member of the one group has more resources than all the opposition put together*, this often makes for a pretty lobsided game. Especially when one party begins exploiting safeguards put in place by the government to work on behalf of the People.
Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" — requests for agency action that any individual, group or company can file — are being misused by brand-name drugmakers to stave off generic competition.
The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.
Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.
"The brand-name drug industry has found a major new loophole," Stabenow said in an interview. "The way things stand now, even if the FDA finds that a petition was frivolous and rejects it, [the drug companies] can get hundreds of millions of dollars of profits from the delay."
The businessman in me says "Wow, that's clever!" and the pharmacist in me says "That is wrong." And because I fancy myself a person of principle, the latter completely voids out any merit the former sentiment might have carried. If it's Wrong, you don't do it. And inventing citizen petitions to prolong patent protection is Wrong. There is nothing that will convince me otherwise.
Medical research from the standpoint of a publicly-traded company is, by its very nature, a marriage of two opposite ideals: helping people and exploiting themmaking money. It's a fine line to walk, and it's very easy to go too far towards the money-making side, particularly because the executives helming the ships aren't medical professionals: they're mostly business people. And they're driven largely by the demands of a whimsical market.
And then I wake up and remember that Big Pharma isn't all bad: it can't be, because each company is made up of individuals, all of whom have their own unique reasons for doing the jobs they do. While certain moves by certain individuals in certain divisions of certain companies can make the whole look bad, one has to remember the other side as well: the side making real breakthroughs in the name of medical science. These are the people to be admired, regardless of their motivations for doing research and development.
* This is a bad analogy because Big Pharma isn't in on one team while generic drugmakers are on another — Big Pharma compete amongst themselve more than they do with generic manufacturers — but all members of the one group share similar traits: size, market-capitalization, lobbying clout, etc. which put them in a league all their own compared to the generic drugmakers.
[tags]Medicine, pharmacy, Big Pharma, business, ethics[/tags]
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