Drug Dealers to get new rules in the U.S.A.

[Jeunemaitre]

I say: so what?

Well, a lot of people agree with you, however...
While the private insurance industry has been taking steps to make coverage decision making a more evidence based enterprise, the availability of that evidence is the targeted take-down of cutting drug prices.

Think of it like an internet start-up, before these companies make money, they have to lay out for drug development (can't sell ads before you have content to draw surfers). Now who's going to fund the start up? Shareholders. Okay, now phase I studies of 50 possible drugs (animal tests)? Shareholders! Okay now you have 10 possible drugs left, who'll fund dose finding studies (phase II)? Shareholders! Okay with 2 possible drugs left, lets start phase III trials... Now into phase IIIb studies running alongside review by the FDA with 1 viable drug. Now lets say approval is granted on the first submission (it could happen) who's ready to by the drug and use it? NOBODY!
Okay, lets run phase 4 naturalistic trials and outcomes research, shareholders.

Now, once you've brought one drug to market, you have about 5 years to make it count because your 10 year patent filed when you first found the compound will then expire. So for five years you can replace the "Shareholders" in the above sequence with profit from "Drug One."

The reason that drug prices are so high is that it takes years of research and 49 some failures to get one "good" drug, then you have to prove that the drug is worthwhile above the doubts raised by the FDA and the private insurance market. Oh yeah, and you can't send anything (ad, information, sample, anything) to a decision maker unless they send a letter to you asking for it first.

The way to make money it to get reimbursement from insurance companies. How do you get reimbursed, you provide information from all of your trials to formulary decision makers. How do they get information? They have to ask you for it. How will they ask you for it? By seeing direct-to-consumer (DTC) ads, or hearing about it at trade shows.

I agree there should be no interference from pharma companies in the prescribing patterns of individual physicians, but there has to be some compromise made between the volumes of information that the FDA makes these companies present before their products can be marketed, and the paucity of information that the companies can provide to decision makers. I think the FDA has the right idea: get as much information as possible and then see a drug in terms of its benefits and side-effects, but they need to remember that they're not the only ones guarding the gates of pharmacotherapy.

edit: Damn, I'm long winded